Read Microsoft Word - GMDN_EDMA_Codes.rtf text version

GMDN to EDMA code correlation table

31 May 2005

GMDN Term

No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term

GMDN Code

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

EDMA Code

11 01 01 09 11 01 01 14 11 01 01 20 11 04 03 06 11 04 04 01 11 04 04 02 11 04 04 04 11 04 04 05 11 04 04 90 11 30 01 01 11 30 01 02 11 30 01 03 11 30 01 11 11 30 01 90 11 30 04 02 11 30 04 03 11 30 04 04 11 30 04 11 11 30 04 90 11 50 01 03 11 50 01 90 11 50 03 03 11 50 30 01 11 50 90 90 11 70 01 05 11 70 01 06 11 70 01 07 11 70 01 50 11 70 03 02 11 70 03 90 11 70 90 90 11 90 01 01

EDMA Term

Angiotensin Converting Enzyme (CC) IC =>12.06.02.03 Creatine Kinase - MB "Activity"(CC) IC =>12.01.05.02 Lactate Dehydrogenase P ( LDH - P --> L ) Bilirubin - Electrodes Reference Electrodes Electrolyte Electrode Buffers and Solutions Substrate Electrode Buffers and Solutions Common Buffers and Solutions (Electrolytes) Other Buffers and Solutions (Electrolytes) Multiple Enzymes only - Clin. Chem Lab R. Multiple Substrates only - Clin. Chem Lab R. Multiple Electrolytes only - Clin. Chem Lab R. Multiple Parameters (Mix of all) - Clin. Chem Lab R. Other Multiple Clin. Chem Lab Reagents Multiple Substrates only - Electrodes/Biosensors Multiple Electrolytes only - Electrodes/Biosensors Multiple Blood Gas only - Electrodes/Biosensors Multiple Parameters (Mix of all) - Electrodes/Biosensors Other Multiple Parameter - Electrodes/Biosensors Unassayed Multicomponent Sera (CC) Other Multicomponent Sera (CC) Aqueous Standards (CC) Multiple Parameter Calibrators and Standards Electrodes/Biosensors Other, Other Controls Clinical Chemistry Triglyceride Test Strips Urea Test Strips HbA1c Test Strips Calibrators and Controls (Blood Test Strips) Albumin in stool (Meconium) Other Faeces Tests Other Clin. Chem. Rapid Tests Buffers (unassignable), Supplem. Reagents, etc (CC)

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 1 of 108

GMDN Term

No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term

GMDN Code

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

EDMA Code

11 90 01 10 12 01 01 30 12 01 01 31 12 01 01 80 12 02 01 06 12 02 01 08 12 02 01 09 12 03 01 10 12 03 01 46 12 03 02 90 12 03 03 01 12 03 90 18 12 04 01 12 12 05 01 13 12 05 02 09 12 05 02 10 12 06 01 07 12 06 02 90 12 06 03 17 12 06 03 18 12 06 04 90 12 06 05 06 12 06 05 07 12 06 05 08 12 06 05 09 12 06 05 90 12 06 30 01 12 06 30 90 12 06 90 02 12 06 90 12 12 06 90 13 12 06 90 14 12 06 90 15 12 06 90 16 12 06 90 17 12 06 90 18 12 07 01 06 12 07 01 07 12 07 01 90 12 07 30 01

EDMA Term

Electrophoresis Media (unassignable) Immunoelectrophoresis kits Immunofixation kits Buffers (unassignable), Supplem. Reagents, etc (Ig's) Immunoglobulin E - Screen Allergene specific IgA Allergene specific IgG Cancer Antigen 27.29 Cancer Associated Serum Antigen Other Receptor Assays HER-2/neu GT=>16 02 01 13 00 Protein S-100 B Neonatal Thyroxine Corticoid-binding Globulin Glycoprotein a Subunit Pregnancy associated Plasma Protein - A (Downs) Thyrosin Phosphatase IA2 Antibodies Other Renal metabolism tests Tartrate-resistant Acid Phosphatase 5b Procollagen Type I N terminal propeptide Other Endocrine Hormones (Growth Factors) a-Melanocite Stimulating Hormones Neurotensin Somatostatin Substance P Other Neoendocrine Function Assays Adrenalin / Noradrenalin / Dopamin Other Multiple Ind. A. Spec. Hormones Gonadotropin-Releasing Hormone Elastase (Pancreatic Polypeptide) Adrenalin Noradrenalin Dopamine Procalcitonin Leptin Motilin Soluble Transferrin Receptor Reticulocyte Haemoglobin Content Other Anemia Vitamin B 12 / Folate

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 2 of 108

GMDN Term

No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term

GMDN Code

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

EDMA Code

12 07 30 90 12 08 01 90 12 08 04 90 12 08 05 90 12 08 06 04 12 08 06 05 12 08 06 90 12 09 01 16 12 09 02 19 12 10 01 90 12 10 02 05 12 10 02 12 12 10 02 90 12 10 03 90 12 10 90 12 12 10 90 16 12 10 90 17 12 10 90 18 12 10 90 19 12 10 90 21 12 10 90 22 12 10 90 24 12 11 01 07 12 11 01 21 12 12 01 02 12 12 90 90 12 13 01 09 12 13 01 90 12 50 01 30 12 70 01 01 12 70 01 90 12 70 03 90 12 70 08 11 12 70 08 90 12 70 09 70 12 70 11 01 12 70 11 90 12 70 13 04 12 70 13 90 12 90 01 01

EDMA Term

Other Multiple Anemia / Vitamine Tests Other Cardiovascular TDM Other Anti-asthma TDM Other Anti-neoplastic TDM Rapamycin (Sirolimus) Mycophenolate Other Immunosuppressant TDM 6-Acethylmorphium Tox adulteration Other ANA / ENA Gal(ß1-3) Anti-GQ1b Other Neuro-Auto-Immunology Other Thyroid-Auto-Immune Disease Tests Sp 100 Antibodies Antibodies to endomysial Autoantigenes Antibodies to soluble Liverantigenes Nucleosome Antibodies Saccharomyces cerevisiae Antibodies Tissue Transglutaminase Antibodies Tissue Transglutaminase/ Gliadin Antibodies Combitest LDL Antibodies Anti-Staphylolysin (qualitative) A-Streptococcal Screening Carbo Hydrate Deficient Transferrin Other Organ Function Assays Homocysteine Other Cardiac Proteins Multi Constituents Immunochemistry Controls Albumin incl. uAlbumin Rapid Test IC => 12 01 03 01 Other Specific Proteins Rapid Tests Other Tumour Marker Rapid Tests Theophylline - Rapid Test Other TDM Rapid Tests Multiple Drugs of Abuse/Toxicology Rapid Tests C-Reactive Protein - Rapid Test Other Rheumatoid - Inflammatory Rapid Tests Brain Natriuric Peptide - Rapid Test Other Cardiac Marker Rapid Tests Antisera (monovalent and polyvalent)

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 3 of 108

GMDN Term

No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term

GMDN Code

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

EDMA Code

12 90 01 70 12 90 01 80 12 90 90 90 13 01 02 90 13 01 70 01 13 01 70 02 13 01 70 03 13 01 70 90 13 02 01 90 13 02 02 21 13 02 02 22 13 02 04 90 13 02 05 09 13 02 05 90 13 02 06 10 13 02 06 12 13 02 70 02 13 02 70 03 13 02 70 04 13 02 70 90 13 02 80 02 13 02 80 80 13 02 90 90 13 03 02 01 13 03 02 90 13 03 04 06 13 03 20 90 13 03 90 90 13 05 01 90 13 06 01 03 13 06 01 06 13 06 01 90 13 07 01 08 13 07 01 09 13 07 01 10 13 07 01 90 13 90 90 90 14 01 01 02 14 01 01 03 14 01 02 21

EDMA Term

Buffers (unassignable ), Supplem. Reagents, etc (IC) Coated Tubes and Beads (unassignable) (IC) Other, Other Immunochemistry Reagents Other Haemoglobin Testing Haemoglobin (Hb) Erythrocytes (Ery) Haematocrit (HCT) Other Rapid Haematology Tests Other Global Coagulation Tests Coagulation factor von Willebrand RCO Coagulation factor von Willebrand CBA Other Primary Hemostasis Thrombin Activating Fibrinolysis Inhibitor Other Fibrinolysis Tests Heparin Cofactor II - Tissue Factor Pathway Inhibitor Pro C Global Activated Partial Thromboplastin Time Rapid Test D-Dimer - Rapid Test Activated Clotting Time Rapid Test Other Haemostasis Rapid Tests Citrate Coated tubes (Citrate, Heparin etc.) Other Haemostasis Reagents Rhesus D Other Rhesus Typing Assays Enhancement Media (e.g. Bovine Albumin,LISS,PEG) Other immunohaematology Controls Other Other Immunohaematology Tests Other Monoclonal Antibodies Soluble Antigens / Receptors Colony Stimulating Factors (G-CSF,M-CSF,GM-CSF) Other Lymphokines /Immunmodulators Stain solutions (Histology/Cytology) Primary antisera for immunohistology Secondary antisera for immunohistology Other Histology / Cytology reagents Other Haematology DCM (susceptibility testing) Raw materials for preparing DCM Sample transport for NA Testing

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 4 of 108

GMDN Term

No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term

GMDN Code

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

EDMA Code

14 01 02 30 14 01 02 90 14 01 03 03 14 01 03 90 14 01 04 90 14 01 05 01 14 01 05 02 14 01 05 03 14 01 05 90 14 01 06 10 14 01 06 90 14 01 07 90 14 01 08 02 14 01 08 03 14 02 01 02 14 02 01 03 14 02 01 04 14 02 01 06 14 02 01 90 14 02 02 03 14 02 02 04 14 02 02 08 14 02 03 02 14 02 03 04 14 02 03 90 14 02 04 01 14 02 04 02 14 02 04 03 14 02 04 90 14 02 05 03 14 02 05 05 14 02 06 01 14 02 06 02 14 03 01 90 14 03 02 90 14 03 03 01 14 03 03 02 14 03 03 90 14 03 04 04 14 03 05 90

EDMA Term

Dip Slides (Bacteriology) Other Media in Tubes Susceptibility Testing (Bottles) Other Media in Bottles Other Prepared Media in Plates Broth only (Blood Culture - Manual) Diphasic (Blood Culture - Manual) Paediatric (Blood Culture - Manual) Other Manual Blood Culture (Concentrators, Antibiotic Inactivators Systems for Mycobacteria - Automated Other Automated Blood Culture Other Urine Screening (Bacteriology) Other Stains Gas Generating Kits Non-fermenters - Automated Streptococci - Automated Staphylococci - Automated Haemophilus & Neisseria - Automated Other Automated Identification Streptococci - Manual Staphylococci - Manual Rapid Single Tests (Catalase, Oxidase etc.) Streptococci Meningitis Causative Agents Other Immunological Identification Break-point Systems (Automated) MIC Systems - Automated Combined Susceptibility & Identification Systems (Auto) Other Automated Susceptibility Systems Multipoint Systems Rapid Single Tests (Cefinase etc.) Nucleic Acid Identification - manual Nucleic Acid Identification - automated Other DCM (Mycology) Other Prepared Media in Plates (Mycology) Tubes and Bottled Media for Yeasts and Fungi Dip Slides (Mycology) Other Tubes Media for yeasts and Fungi Identification Systems for Yeasts and Fungi / NA Other Serological Identification of Yeasts and Fungi

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 5 of 108

GMDN Term

No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term

GMDN Code

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

EDMA Code

14 03 06 90 14 04 01 03 14 04 01 04 14 04 01 90 14 05 01 01 14 05 01 90 14 70 01 90 15 01 02 90 15 01 03 90 15 01 04 90 15 01 05 90 15 01 06 05 15 01 06 06 15 01 06 90 15 01 07 90 15 01 08 90 15 01 09 40 15 01 09 90 15 01 10 90 15 01 11 90 15 01 12 11 15 01 12 90 15 01 13 01 15 01 13 03 15 01 13 90 15 01 14 90 15 01 15 40 15 01 15 90 15 01 40 01 15 01 40 02 15 01 40 03 15 01 40 04 15 01 40 05 15 01 40 06 15 01 40 07 15 01 40 08 15 01 40 09 15 01 40 12 15 01 40 13 15 01 40 90

EDMA Term

Other Susceptibility Systems for yeasts and Fungi Serum for Tissue Culture Other Tissue Culture Additives and Solutions Other Virology ( Microbiology ) Reagents Parasitology Extraction Reagents Other Parasitology Stains Other Microbiology Rapid Tests Other Gonococci Reagents Other Syphilis Reagents Other H. Pylori Reagents Other Legionella Reagents Lyme Antibody IgG Lyme Antibody IgM Other Lyme Borelliosis Reagents Other Mycobacteria Reagents Other Mycoplasma Reagents Pseudomonas Detection by NA Reagents Other Pseudomonas Aeruginosa Reagents Other Salmonella Reagents Other Streptococci Reagents Staphylotoxin Other Staphylococci Reagents Listeria Antigen Detection Listeria Antibody Assays Other Listeria Reagents Other Campylobacter Reagents E. Coli Detection by NA Reagents Other E. Coli Reagents Brucella - NA Reagents Clostridium difficile - NA Reagents Coxiella - NA Reagents Leptospira - NA Reagents Rickettsia - NA Reagents Yersinia - NA Reagents Bordetella pertussis / parapertussis - NA Reagents Diphteria (Corynebacterium D.) - NA Reagents Tetanus (Clostridium T.) - NA Reagents Proteus - NA Reagents Pseudomonas - NA Reagents Other Other Bacteriology - NA Reagents

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 6 of 108

GMDN Term

No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term

GMDN Code

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

EDMA Code

15 02 01 40 15 02 01 90 15 02 03 90 15 02 04 90 15 02 05 07 15 02 05 90 15 02 07 90 15 02 24 01 15 02 24 02 15 02 24 04 15 02 24 05 15 02 24 06 15 02 24 40 15 02 24 90 15 02 90 90 15 03 02 01 15 03 02 40 15 03 02 90 15 03 10 40 15 03 20 09 15 03 20 40 15 03 20 90 15 03 30 90 15 03 31 90 15 03 40 90 15 04 01 90 15 04 03 08 15 04 03 09 15 04 03 90 15 04 40 01 15 04 40 02 15 04 40 04 15 04 40 05 15 04 40 06 15 04 40 07 15 04 40 08 15 04 40 09 15 04 40 10 15 04 40 11 15 04 40 12

EDMA Term

Hepatitis A Virus - NA Reagents Other HAV Reagents Other HCV Reagents Other HDV Reagents HEV Antibody - Confirmatory Other HEV Reagents Other HGV Reagents HXV Antigen HXV Antigen - Confirmatory HXV Antibody (Total) HXV Antibody IgG HXV Antibody IgM Hepatitis X Virus - NA Reagents Other HXV Reagents Other Hepatitis Virus Reagents HIV 2 Antigen HIV 2 - NA Reagents Other HIV 2 Reagents HIV P24 - NA Reagents HIV Multiple Ag/Ab Combi Test HIV Multiple - NA Reagents Other HIV Multiple Reagents Other HTLV I Reagents Other HTLV II Reagents Other HTLV Multiple Reagents Other Rubella Virus Reagents HSV 1 IgG HSV 1 IgM Other HSV Reagents Adenovirus - NA Reagents Enterovirus - NA Reagents Influenza & Para Influenza - NA Reagents Respiratory Syncytial Virus (RSV) - NA Reagents Rotavirus - NA Reagents Measles - NA Reagents Mumps / Parotitis - NA Reagents Parvovirus B 19 - NA Reagents Varicella Zoster Virus - NA Reagents Dengue Virus - NA Reagents FSME Virus - NA Reagents

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 7 of 108

GMDN Term

No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term

GMDN Code

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

EDMA Code

15 04 40 13 15 04 40 14 15 04 80 11 15 04 80 12 15 04 80 14 15 04 90 90 15 05 01 90 15 30 02 40 15 30 02 90 15 50 01 30 15 50 01 90 15 70 01 01 15 70 01 90 15 70 02 90 15 70 03 01 15 70 03 90 15 70 90 02 15 70 90 03 15 70 90 90 15 90 90 01 15 90 90 40 15 90 90 90 16 01 01 01 16 01 01 02 16 01 01 03 16 01 01 04 16 01 01 05 16 01 01 06 16 01 01 07 16 01 01 08 16 01 01 10 16 01 01 11 16 01 01 12 16 01 01 13 16 01 01 14 16 01 01 90 16 01 02 01 16 01 02 02 16 01 02 03 16 01 02 04

EDMA Term

LCM Virus - NA Reagents Hantavirus / Bunyavirus - NA Reagents Dengue Virus FSME Virus Hantavirus / Bunyavirus Other Other Virology Reagents Other Toxoplasma Antibody HCV / HIV Combination - NA Reagents Other Multiple Viruses Multiconstituent Controls - Inf.Imm. Other Controls Inf. Immunology Chlamydia AG - Rapid Test Other Bacteriology Rapid Tests Other Hepatitis Viruses Rapid Tests HIV 1 - Rapid Test Other Retroviruses Rapid Tests RSV - Rapid Test Mononucleosis - Rapid Test Inf. Imm.=>15 04 04 11 Other Other Virology Rapid Tests Buffers (unassignable ), Supplem. Reagents, etc Supplem. Reagents, etc - NA Reagents Other Other Infectious Immunology Reagents Cystic Fibrosis Duchenne Muscular Dystrophy Factor V Leiden Fragile X Syndrome Haemochromatosis Haemophilia Huntington Chorea Polycystic Kidney Disease Tay Sachs Disease Thalassaemia Friedreich's Ataxia Spihocerebellar Ataxins Type 1,2,3,6,7,8 Prothrombin Mutation Other Monogenetic Disorders Tests Alzheimer's Disease Asthma Atherosclerosis Diabetes

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 8 of 108

GMDN Term

No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term

GMDN Code

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

EDMA Code

16 01 02 05 16 01 02 06 16 01 02 07 16 01 02 90 16 01 04 01 16 01 04 90 16 02 01 01 16 02 01 02 16 02 01 03 16 02 01 04 16 02 01 05 16 02 01 06 16 02 01 07 16 02 01 08 16 02 01 09 16 02 01 10 16 02 01 11 16 02 01 12 16 02 01 13 16 02 01 90 21 01 30 01 21 03 10 01 21 03 30 01 21 04 30 01 21 05 30 01 21 07 30 01 21 07 30 09 21 09 10 01 21 09 30 01 23 02 30 01 23 03 30 01 23 04 30 01 23 07 30 01 24 02 30 01 24 02 30 02 25 01 10 01 25 07 10 01 25 07 30 01 26 01 30 01 27 01 10 01

EDMA Term

Hypertension Multiple Sclerosis Osteoporosis Other Polygenetic Disorders Tests HLA-Typing Other Polymorphism Tests p53 k-ras BRCA 1+2 ret c-myc HNPCC APC t(9;22) t(8;14) t(14;18) inv (16) Telomerase HER-2/neu Other Acquired Gene or Chromosome Alteration Tests CH Consumables IM Hardware + dedicated accessories + software IM Consumables GE Consumables EP Consumables Diabetes Management Consumables Other RT_IC Consumables Other_CI Hardware + dedicated accessories + software Other_CI Consumables HS Consumables BG Consumables FC Consumables RT_HHC Consumables BC Consumables MB Consumables II Hardware + dedicated accessories + software RT_II Hardware + dedicated accessories + software RT_II Consumables NA Consumables MA Hardware + dedicated accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 9 of 108

GMDN Term

No Equivalent GMDN term No Equivalent GMDN term No Equivalent GMDN term Microhaematocrit centrifuge Tabletop centrifuge Analyser, laboratory, haematology, cell counting, manual Blood gas monitor Blood gas monitor, carbon dioxide Oxygen monitor, transcutaneous pH monitor Osmometer Spectrophotometer, atomic absorption Spectrophotometer, fluorescence Spectrophotometer, infrared Spectrophotometer, ultraviolet Spectrophotometer, ultraviolet/visible light Spectrophotometer, visible Analyser, laboratory, body fluids, alcohol Analyser, laboratory, body fluids, amino acid Analyser, laboratory, microbiology, susceptibility Analyser, laboratory, blood, urea nitrogen Analyser, laboratory, haematology, coagulation, automated Analyser, laboratory, body fluids, electrolyte Analyser, laboratory, body fluids, enzyme Analyser, laboratory, body fluids, glucose Analyser, laboratory, body fluids, nitrogen Analyser, laboratory, haematology, platelet aggregation Bilirubinometer Cytometer, manual Centrifuge, floor Centrifuge, refrigerated Analyser, laboratory, body fluids, chloride Laboratory information system Counter, bacteria Cytometer, manual, differential Slide dispenser Photofluorometer Freezer, blood plasma Analyser, laboratory, haematology, haemoglobin Immunofluorescence equipment

GMDN Code

0 0 0 10779 10780 11996 12586 12588 12592 12634 12842 15079 15080 15081 15082 15083 15084 15089 15090 15091 15092 15098 15100 15101 15102 15103 15104 15109 15112 15116 15117 15118 15124 15125 15132 15135 15141 15144 15146 15150

EDMA Code

27 01 30 01 28 01 30 01 29 01 30 01 23 09 10 01 28 01 10 01 23 01 10 01 21 04 10 01 21 04 10 01 00 00 00 00 00 00 00 00 00 00 00 00 21 04 10 01 21 01 10 01 21 01 10 01 21 01 10 01 21 01 10 01 21 01 10 01 21 07 10 09 21 02 10 01 24 01 10 01 21 01 10 01 23 02 10 01 21 04 10 01 21 01 10 01 21 01 10 01 21 01 10 01 23 02 10 01 21 01 10 01 23 05 10 01 28 01 10 01 28 01 10 01 21 04 10 01 29 01 10 24 09 10 01 23 05 10 01 23 05 30 01 21 02 10 01 00 00 00 00 23 09 10 01 21 02 10 01

EDMA Term

MA Consumables SP Consumables Other Consumables Other_HHC Hardware + dedicated accessories + software SP Hardware + accessories + software CC Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software Not for IVD use Not for IVD use Not for IVD use GE Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software Other RT_CI Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software SI Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software HC Hardware + dedicated accessories + software SP Hardware + accessories + software SP Hardware + accessories + software GE Hardware + dedicated accessories + software Other Hardware + dedicated accessories + software Other_MCB Hardware + dedicated accessories + software HC Hardware + dedicated accessories + software HC Consumables IC Hardware + dedicated accessories + software Not for IVD use Other_HHC Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 10 of 108

GMDN Term

GMDN Code

15161 15168 15177 15182 15183 15301 15551 15552 15601 15663 15709 15714 15776 15892 15970 15973 16014 16166 16217 16218 16273 16299 16300 16301 16302 16373 16374 16377 16378 16382 16383 16404 16456 16488 16525 16530 16531 16609 16749 16765

EDMA Code

00 00 00 00 00 00 00 00 23 09 10 01 23 05 10 01 23 05 10 01 21 02 10 01 21 01 10 01 23 02 10 01 21 01 10 01 28 01 10 01 21 04 10 01 28 01 10 01 21 04 10 01 00 00 00 00 00 00 00 00 24 02 10 01 23 03 10 01 21 01 10 01 21 02 10 01 21 02 10 01 24 01 30 01 21 01 10 01 21 01 10 01 21 01 10 01 21 01 10 01 23 02 10 01 23 09 10 01 23 01 10 01 21 01 10 01 21 02 10 01 21 02 10 01 28 01 10 01 28 01 10 01 21 07 10 01 00 00 00 00 21 04 10 01 23 07 10 01 23 04 10 01 23 07 10 01 28 01 10 01

EDMA Term

Not for IVD use Not for IVD use Other_HHC Hardware + dedicated accessories + software HC Hardware + dedicated accessories + software HC Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software SP Hardware + accessories + software GE Hardware + dedicated accessories + software SP Hardware + accessories + software GE Hardware + dedicated accessories + software Not for IVD use Not for IVD use BC & MB Hardware + dedicated accessories + software BG Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software SI Consumables CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software Other_HHC Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software SP Hardware + accessories + software SP Hardware + accessories + software Diabetes Management Hardware + dedicated accessories + software Not for IVD use GE Hardware + dedicated accessories + software RT_HHC Hardware + dedicated accessories + software FC Hardware + dedicated accessories + software RT_HHC Hardware + dedicated accessories + software SP Hardware + accessories + software

Mixer, clinical laboratory Pump, laboratory Sedimentation rate unit Slide stainer, haematology Slide stainer, histology RIA (RadioImmunoAssay) analyser Analyser, laboratory, clinical chemistry Coagulation analyser, manual Spectrophotometer Pipetter Analyser, laboratory, blood gas/pH Centrifuge tube adapter Blood potassium monitor Analyser, laboratory, breath, helium Carbon dioxide monitor, transcutaneous Analyser, laboratory, microbiology, blood culture, automated Analyser, laboratory, haematology, blood grouping Bilirubinometer, cutaneous Analyser, laboratory, immunoassay, photometric, enzyme Analyser, laboratory, immunoassay, fluorimetric Dispenser, antibiotic sensitivity disk Analyser, Laboratory, clinical chemistry, automated, discrete Analyser, laboratory, clinical chemistry, automated, centrifugal Analyser, laboratory, clinical chemistry, automated, continuous flow Analyser, laboratory, clinical chemistry, manual Platelet aggregation recorder, automated Hematofluorometer Counter, platelet, automated Analyser, laboratory, urine, automated Analyser, laboratory, radioimmunoassay, automated Analyser, laboratory, radioimmunoassay, semiautomated Diluter, blood cell Concentrator, specimen Blood glucose monitor, portable Disrupter, cell Analyser, laboratory, body fluids, electrolyte, flame photometer Photometer, reflectance Cytometer, flow Analyser, point-of-care, whole blood, coagulation Cytological centrifuge

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 11 of 108

GMDN Term

Analyser, laboratory, body fluids, lactate Bath, water, plasma-thawing Centrifuge, cell washing, automatic Blood grouping system, automated Analyser, laboratory, body fluids, electrolyte, ion-selective Analyser, laboratory, body fluids, electrolyte, coulometric Analyser, laboratory, radioimmunoassay, manual Cytometer, automated, flow Syringe, gas/liquid chromatography Analyser, laboratory, urine, semiautomated Densitometer, laboratory, scanning light Analysers, laboratory, immunoassay, nephelometric Calibrator, blood gas Analyser, laboratory, body fluids, calcium Slide stainer, microbiological Analyser, laboratory, semen Antimicrobial reagent disk Blood grouping/typing serum Culture media Culture medium, differential, microbiological Culture medium, mycobacteriology Mycology culture media Culture media, Mycoplasma Culture medium, selective, microbiological Culture media, tissue Culture medium, virology Fixative, electron microscopy Fixative, light microscopy Reagent, decalcifying, electron microscopy Reagent, decalcifying, light microscopy Reagent, quality control, coagulation Reagent, quality control, urinalysis Stain, haematology Stain, light microscopy, cytology Stain, light microscopy, histology Stain, microbiology Analyser, laboratory, blood, glycohemoglobin Reagent, quality control, blood gas/pH Analyser, laboratory, body fluids, catecholamine Analyser, laboratory, haematology, coagulation, semiautomated

GMDN Code

16773 16796 16815 16817 16818 16819 16865 16867 16876 16887 16905 16908 16929 16940 16961 16984 17005 17013 17014 17016 17017 17018 17019 17021 17022 17023 17025 17026 17049 17050 17059 17067 17080 17083 17084 17085 17109 17128 17173 17176

EDMA Code

21 01 10 01 00 00 00 00 28 01 10 01 23 03 10 01 21 04 10 01 21 04 10 01 21 02 10 01 23 04 10 01 00 00 00 00 21 01 10 01 21 05 10 01 21 02 10 01 11 50 90 01 21 04 10 01 24 09 10 01 21 02 10 01 14 02 05 02 13 03 01 02 14 01 14 02 14 01 03 10 14 03 14 02 02 07 14 01 14 04 01 02 14 04 13 07 01 05 13 07 01 05 13 02 80 90 13 02 80 90 13 02 50 11 50 90 02 13 01 03 01 13 01 03 01 13 01 03 01 14 01 08 21 07 10 09 11 50 90 01 21 02 10 01 23 02 10 01

EDMA Term

CH Hardware + dedicated accessories + software Not for IVD use SP Hardware + accessories + software BG Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software FC Hardware + dedicated accessories + software Not for IVD use CH Hardware + dedicated accessories + software EP Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software Blood gas control GE Hardware + dedicated accessories + software Other_MCB Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software Impregnated Disks, Multi-disks & Tablets ABO sera Bacteriology - Culture Bacteriology - Identification & Susceptibility Testing Mycobacteria media (Bottles) Mycology Mycoplasma - Manual Bacteriology - Culture Media for Tissue Culture Viral Culture Fixing reagents (Histology/Cytology) Fixing reagents (Histology/Cytology) Other Auxiliary Reagents (Haemostasis) Other Auxiliary Reagents (Haemostasis) Haemostasis Controls Urine Control Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Stains, Buffers etc (Bacteriology) Other RT_CI Hardware + dedicated accessories + software Blood gas control IC Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 12 of 108

GMDN Term

Centrifuge, floor, nonrefrigerated Analyser, laboratory, body fluids, creatinine Reagent, allergen specific immunoglobulin E Reagent, allergen specific immunoglobulin G Reagent, alpha-1-acid glycoprotein Reagent, alpha-1-antitrypsin Reagent, alpha-2-macroglobulin Reagent, alpha fetoprotein Reagent, antideoxyribonucleoprotein/anti-DNA Reagent, antimitochondrial antibody Reagent, anti-ndna antibody Reagent, antinuclear (HEp-2 cell substrate) antibody Reagent, antinuclear (KB cell substrate) antibody Reagent, antinuclear (tissue substrate) antibody Reagent, antinuclear/autoantibody multiple test system Reagent, antiparietal cell antibody Reagent, anti-smooth muscle antibody Reagent, antistreptolysin O Reagent, antistreptolysin O/antideoxy-ribonuclease Reagent, antithyroglobulin antibody Reagent, antithyroid-microsomal antibody Reagent, Aspergillus antibody Reagent, Bordetella pertussis antibody Reagent, Brucella antibody Reagent, C reactive protein Reagent, Candida albicans detection Reagent, Candida albicans antibody Reagent, carcinoembryonic antigen Reagent, ceruloplasmin Reagent, Chlamydia trachomatis detection Reagent, Legionella pneumophila detection Reagent, Legionella species Reagent, measles (rubeola) antibody Reagent, mumps virus antibody Reagent, Mycoplasma pneumoniae detection Reagent, Mycoplasma pneumoniae antibody Reagent, Mycoplasma/ureaplasma detection Reagent, myelin basic protein Reagent, myoglobin Reagent, Neisseria species detection

GMDN Code

17177 17182 17254 17255 17256 17257 17258 17259 17264 17267 17268 17269 17270 17271 17273 17274 17276 17278 17279 17280 17282 17284 17288 17289 17290 17291 17292 17293 17295 17296 17297 17298 17307 17309 17310 17311 17312 17313 17314 17315

EDMA Code

28 01 10 01 21 01 10 01 12 02 01 03 12 01 01 05 12 01 90 01 12 01 90 02 12 01 90 03 12 03 90 01 12 10 01 05 12 10 90 02 12 10 01 05 12 10 01 01 12 10 01 01 12 10 01 01 12 10 01 01 12 10 90 11 12 10 01 11 12 11 01 05 12 11 01 05 12 10 03 04 12 10 03 01 15 06 01 01 15 01 90 07 15 01 90 01 12 11 01 09 15 06 01 02 15 06 01 02 12 03 01 31 12 01 03 02 15 01 01 01 15 01 05 01 15 01 05 01 15 04 80 07 15 04 80 08 15 01 08 01 15 01 08 03 15 01 08 01 12 10 02 07 12 13 01 05 15 01 90 11

EDMA Term

SP Hardware + accessories + software CH Hardware + dedicated accessories + software Immunoglobulin E - Specific, monotest/monoresult Immunoglobulin G a1-Acid Glycoprotein ( Orosomucoid ) a1-Antitrypsin ( Protease inhibitor ) a2-Macroglobulin Alphafetoprotein ds DNA - Antibodies Anti-Mitochondrial Antibodies ds DNA - Antibodies ANA Screening ANA Screening ANA Screening ANA Screening Parietal Cell Antibodies Sm Anti-Streptolysin/Anti-Streptolysin O (qualitative) Anti-Streptolysin/Anti-Streptolysin O (qualitative) Thyroglobulin Autoantibodies Thyroid Peroxidase (incl. Microsomal) Antibodies Aspergillus Bordetella pertussis / parapertussis Brucella C-Reactive Protein IC=> 12 70 11 01 Candida albicans Candida albicans Carcinoembryonic Antigen Ceruloplasmin Chlamydia Antigen Detection Legionella Antigen Detection Legionella Antigen Detection Measles Mumps / Parotitis Mycoplasma Antigen Detection Mycoplasma Antibody Assays Mycoplasma Antigen Detection Anti-MAG (Myelin Associated Glycoprotein) Myoglobin Neisseria meningitidis

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 13 of 108

GMDN Term

Reagent, Neisseria gonorrhoeae detection Reagent, Neisseria meningitidis detection Reagent, papillomavirus detection Reagent, plasminogen Reagent, plasminogen activator Reagent, Chlamydia trachomatis antibody Reagent, circulating immune complexes Reagent, Coccidiodes immitis antibody Reagent, Cryptococcus neoformans Reagent, Cryptococcus neoformans antibody Reagent, cytomegalovirus antibody Reagent, cytomegalovirus antibody-IgG/IgM Reagent, cytomegalovirus antibody-IgM specific Reagent, Entamoeba histolytica antibody Reagent, Enterobacteriaceae detection Reagent, Epstein-Barr virus antibody Reagent, Epstein-Barr virus antibody-IgM specific Reagent, ferritin Reagent, fibrin degradation products Reagent, Franciscella tularensis antibody Reagent, Gardnerella vaginalis Reagent, Gram stain Reagent, Haemophilus species Reagent, Haemophilus influenzae B antigen Reagent, haptoglobin Reagent, hemopexin Reagent, Hepatitis A antibody Reagent, Hepatitis A antibody-IgM specific Reagent, Hepatitis B core antibody Reagent, hepatitis b core antibody-igm specific Reagent, Hepatitis B core antigen Reagent, hepatitis Be antibody/antigen Reagent, Hepatitis B surface antibody Reagent, Hepatitis surface antigen Reagent, hepatitis B surface antigen-confirmatory Reagent, Herpes simplex detection Reagent, Herpes simplex antibody Reagent, Herpes simplex antibody-IgM specific Reagent, Histoplasma capsulatum antibody Reagent, immunoglobulin A

GMDN Code

17316 17317 17319 17322 17323 17325 17326 17329 17332 17333 17334 17335 17336 17337 17338 17339 17340 17342 17343 17344 17347 17348 17349 17350 17351 17352 17353 17354 17355 17356 17357 17358 17359 17360 17361 17362 17363 17364 17366 17369

EDMA Code

15 01 02 01 15 01 90 11 15 04 80 03 13 02 05 05 13 02 05 06 15 01 01 03 12 11 01 08 15 06 01 90 15 06 01 90 15 06 01 90 15 04 02 04 15 04 02 05 15 04 02 06 15 05 10 01 14 02 02 01 15 04 04 04 15 04 04 04 12 07 01 02 13 02 05 02 15 01 90 90 15 05 10 90 14 01 08 01 15 01 90 10 15 01 90 10 12 01 03 03 12 01 03 04 15 02 03 04 15 02 03 06 15 02 02 14 15 02 02 16 15 02 02 11 15 02 02 24 15 02 02 04 15 02 02 01 15 02 02 02 15 04 03 01 15 04 03 04 15 04 03 06 15 06 01 90 12 01 01 01

EDMA Term

Gonococcal Antigen Detection Neisseria meningitidis Human Papilloma Virus Plasminogen Plasminogen Activator-Inhibitors Chlamydia Antibody Assays Total Circulating Immune Complexes Other Mycology Immunoassays Other Mycology Immunoassays Other Mycology Immunoassays CMV Antibodies - Total CMV IgG CMV IgM Entamoeba histolytica Enterobacteriaceae - Manual EBV Antibodies EBV Antibodies Ferritin Fibrinogen Degradation Products Other Other Bacteriology Immunoassays Other Parasitology Gram's Stain Haemophilus influenzae Haemophilus influenzae Haptoglobin Haemopexin HCV Antibody (Total) HCV Antibody IgM Hepatitis B Core Antibody (Total) Hepatitis B Core Antibody IgM Hepatitis B Core Antigen Hepatitis Be Antibody (Total) Hepatitis B Surface Antibody (Total) Hepatitis B Surface Antigen Hepatitis B Surface Antigen - Confirmatory HSV Antigen HSV Antibodies - Total HSV IgM Other Mycology Immunoassays Immunoglobulin A

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 14 of 108

GMDN Term

Reagent, immunoglobulin D Reagent, immunoglobulin E Reagent, immunoglobulin G Reagent, immunoglobulin M Reagent, properdin factor b Reagent, Proteus OX antibody Reagent, rapid Streptococcus detection Reagent, retinol binding protein Reagent, rheumatoid factor Reagent, rickettsia antibody Reagent, Rotavirus detection Reagent, rubella virus antibody Reagent, rubella virus antibody-IgM specific Reagent, salmonella antibody Reagent, Staphylococcus aureus detection Reagent, Streptococcus detection Reagent, Streptococcus group Reagent, Streptococcus group A detection Reagent, Streptococcus group B detection Reagent, Streptococcus pneumoniae detection Reagent, syphilis-reagin antibody Reagent, syphilis-treponemal antibody Reagent, syphilis-treponemal antibody/antigen Reagent, thyroglobulin Reagent, Toxoplasma gondii antibody Reagent, Toxoplasma gondii antibody-IgM specific Reagent, transferrin Reagent, Trichinella spiralis antibody Reagent, Trichomonas species Reagent, varicella-zoster virus antibody Reagent, yeast detection Reagent, occult blood, fecal Reagent, occult blood, gastric Reagent, strip, glucose Reagent, strip, multichemistry Microscope, stereo Culture medium, enrichment, microbiological Microcentrifuge Analyser, laboratory, breath Analyser, point-of-care, breath, alcohol

GMDN Code

17370 17371 17372 17373 17374 17375 17377 17378 17379 17380 17381 17382 17383 17384 17386 17388 17389 17390 17391 17392 17393 17394 17395 17398 17400 17401 17402 17403 17404 17405 17406 17410 17411 17419 17420 17439 17451 17452 17474 17475

EDMA Code

12 01 01 03 12 02 01 02 12 01 01 05 12 01 01 07 12 01 02 90 15 01 90 12 15 70 01 03 12 01 03 07 12 11 01 10 15 01 90 05 15 04 80 06 15 04 01 04 15 04 01 06 15 01 10 03 15 01 12 01 15 01 11 01 15 01 11 01 15 01 11 01 15 01 11 01 15 01 11 01 15 01 03 03 15 01 03 03 15 01 03 03 12 04 01 08 15 05 01 04 15 05 01 06 12 01 03 08 15 05 10 90 15 05 10 90 15 04 80 10 14 03 04 03 12 03 90 04 12 03 90 04 11 70 01 01 11 70 01 90 00 00 00 00 14 01 03 04 28 01 10 01 00 00 00 00 00 00 00 00

EDMA Term

Immunoglobulin D Immunoglobulin E - Total Immunoglobulin G Immunoglobulin M Other Complement Components Proteus Strep A - Rapid Test Retinol Binding Protein Rheumatoid Factors Rickettsia Rotavirus Rubella Virus Antibodies - Total Rubella Virus IgM Salmonella Antibody Assays Staphylococcal Direct Antigen Detection Streptococcal Direct Antigen Detection Streptococcal Direct Antigen Detection Streptococcal Direct Antigen Detection Streptococcal Direct Antigen Detection Streptococcal Direct Antigen Detection Syphilis Antibody Assays Total Syphilis Antibody Assays Total Syphilis Antibody Assays Total Thyroglobulin Toxoplasma Antibody (Total) Toxoplasma Antibody IgM Transferrin Other Parasitology Other Parasitology Varicella Zoster Identification Systems for Yeasts and Fungi - Automated Fecal Occult Blood (IC) CC =>11.70.03.01 Fecal Occult Blood (IC) CC =>11.70.03.01 Glucose Test Strips Other Blood Test Strips Not for IVD use Enrichment media (Bottles) SP Hardware + accessories + software Not for IVD use Not for IVD use

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 15 of 108

GMDN Term

GMDN Code

17476 17480 17607 17645 17656 17740 17741 17742 17778 17779 17780 17847 17894 17914 17916 17941 17994 17996 18102 18127 30155 30156 30157 30158 30159 30160 30161 30162 30163 30164 30165 30166 30167 30168 30169 30170 30171 30172 30173 30174

EDMA Code

00 00 00 00 11 70 02 02 12 01 03 01 00 00 00 00 11 70 01 02 23 01 10 01 23 01 10 01 23 01 10 01 14 05 02 01 15 05 10 07 15 05 10 08 00 00 00 00 14 01 01 90 15 02 03 04 21 02 10 01 11 70 01 90 00 00 00 00 00 00 00 00 00 00 00 00 12 03 01 32 11 02 01 01 11 02 01 02 11 02 01 03 11 02 01 04 11 02 01 05 11 02 01 06 11 02 01 07 11 02 01 08 11 02 01 09 11 02 01 10 11 02 01 11 11 02 01 12 11 02 01 13 11 02 01 14 11 02 01 15 11 02 01 16 11 02 01 18 11 02 01 19 11 02 01 21 11 02 01 22

EDMA Term

Not for IVD use Urine Multi-Constituent Test Strips Albumin (IC) incl. uAlbumin CC =>11.02.01.01 Not for IVD use Cholesterol Test Strips CC Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software Pneumocystis carinii Cryptosporidium Giardia lamblia Not for IVD use Other DCM HCV Antibody (Total) IC Hardware + dedicated accessories + software Other Blood Test Strips Not for IVD use Not for IVD use Not for IVD use Total Prostatic Specific Antigen Albumin (CC) IC =>12.01.03.01 Bile acids Bilirubin Urea/Blood Urea Nitrogen Cholesterol Copper Creatinine D-Xylose Delta-Aminolaevulinic acid Fructosamine Fructose Galactose Glucose Glycosylated/Glycated Haemoglobin IC=12.06.01.06 High Densitiy Lipoprotein Cholesterol Iron (CC) IC =>12.07.01.04 Lactate Lecithin Low Density Lipoprotein Cholesterol Non Esterified Fatty Acids

Analyser, point-of-care, breath, hydrogen Reagent, strip, urinalysis Reagent, urine, albumin Analyser, physiologic, thermometric fertility cycle Reagent, strip, cholesterol Analyser, laboratory, haematology Analyser, laboratory, haematology, cell counting, automated Analyser, laboratory, haematology, cell counting, semiautomated Reagent, Pneumocystis carinii Reagent, Cryptosporidium Reagent, Giardia lamblia Microwave oven, plasma-thawing Holding media Reagent, Hepatitis C antibody Analyser, laboratory, immunoassay, chemiluminescent Reagent, strip, alcohol Detector, protective barrier strike-through Monitor, bedside, blood gas, transcutaneous Aqueous flare/cell meter Reagent, prostate-specific antigen (PSA) Albumin kit Bile acid kit Bilirubin kit Urea nitrogen kit Cholesterol kit, total Copper kit Creatinine kit D-xylose kit Delta-aminolaevulinic acid kit Fructosamine kit Fructose kit Galactose kit Glucose kit Glycated haemoglobin kit High density lipoprotein kit Cr iron, CC Lactate kit Lecithin/sphingomyelin kit Low density lipoprotein kit Non-esterified fatty acid kit

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 16 of 108

GMDN Term

Oxalate kit Phospholipid kit Porphobilinogen kit Pyruvate kit Total lipids kit Total porphyrine kit Total protein kit Triglyceride kit Uric acid kit Atomic absorption spectroscopy kit, zinc Ammonia kit Bicarbonate kit Calcium kit Chloride kit Lithium kit Magnesium kit Phosphorous/inorganic phosphate kit Potassium kit Sodium kit Electrode, ion-selective, ammonia Electrode, ion-selective, calcium Electrode, ion-selective, chloride Electrode, ion-selective, lithium Electrode, ion-selective, magnesium Electrode, ion-selective, potassium Electrode, ion-selective, sodium Electrode, ion-selective, carbon dioxide Electrode, pH, in vitro Electrode, ion-selective, oxygen Electrode, ion-selective, creatinine Glucose electrode Electrode, ion-selective, glycated haemoglobin Electrode, ion-selective, lactate Electrode, ion-selective, urea Blood gas buffer/solution Assayed multicomponent serum kit, normal Assayed multicomponent serum kit, abnormal Enzyme control serum Lipid control serum Bilirubin control

GMDN Code

30175 30176 30177 30178 30179 30180 30181 30182 30183 30184 30185 30186 30187 30188 30189 30190 30191 30192 30193 30194 30195 30196 30197 30198 30199 30200 30202 30203 30204 30205 30206 30207 30208 30209 30210 30211 30212 30213 30214 30215

EDMA Code

11 02 01 23 11 02 01 24 11 02 01 25 11 02 01 26 11 02 01 28 11 02 01 29 11 02 01 30 11 02 01 31 11 02 01 32 11 02 01 33 11 03 01 01 11 03 01 02 11 03 01 03 11 03 01 04 11 03 01 06 11 03 01 07 11 03 01 08 11 03 01 09 11 03 01 10 11 04 01 01 11 04 01 02 11 04 01 03 11 04 01 04 11 04 01 05 11 04 01 06 11 04 01 07 11 04 02 01 11 04 02 02 11 04 02 03 11 04 03 01 11 04 03 02 11 04 03 03 11 04 03 04 11 04 03 05 11 04 04 03 11 50 01 01 11 50 01 01 11 50 02 01 11 50 02 02 11 50 02 03

EDMA Term

Oxalate Phospholipids Porphobilinogen Pyruvate Total Lipids Total Porphyrine Total Protein Triglycerides Uric Acid Zinc Ammonia Bicarbonate Calcium Chloride Lithium Magnesium Phosphate inorganic / Phosphorus Potassium Sodium Ammonia - Electrodes Calcium - Electrodes Chloride - Electrodes Lithium - Electrodes Magnesium - Electrodes Potassium - Electrodes Sodium - Electrodes Carbon Dioxide - Electrodes pH - Electrodes Oxygen - Electrodes Creatinine - Electrodes Glucose - Electrodes Glycated Haemoglobin - Electrodes Lactate - Electrodes Urea - Electrodes Blood Gas Buffers and Solutions Assayed Multicomponent Sera (CC) Assayed Multicomponent Sera (CC) Enzyme Control Sera Lipid Control Sera Bilirubin Control Sera

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 17 of 108

GMDN Term

Clinical chemistry calibrator, multi-component Clinical chemistry calibrator, single-component Blood gas control Urine control Cerebrospinal fluid control Blood glucose test strip Cholesterol test strip, total High density lipoprotein test strip Lactate test strip Urine test strip, single constituent Urine test strip, multiple constituent Urine sediment test kit Immunoglobulin A kit Immunoglobulin A subclass kit Immunoglobulin D kit Immunoglobulin D subclass kit Immunoglobulin G kit Immunoglobulin G subclass kit Immunoglobulin M kit Immunoglobulin M subclass kit Kappa/lambda chain kit Antihuman immunoglobulin polyvalent antiserum kit Human anti-mouse antibody kit Complement component C1q kit Complement component C1 inactivator kit Complement component C3/C3c kit Complement component Bb kit Complement component C4 kit Complement component C5a kit Complement component C5-9 kit Albumin, immunochemistry Ceruloplasmin kit Haptoglobin kit Haemopexin kit Lactoferrin kit Prealbumin/transthyretin kit Retinol binding protein kit Transferrin kit Transcobalamin S kit Lipoprotein kit

GMDN Code

30216 30217 30218 30219 30220 30221 30222 30223 30224 30225 30226 30227 30228 30229 30230 30231 30232 30233 30234 30235 30236 30237 30238 30239 30240 30241 30242 30243 30244 30245 30246 30247 30248 30249 30250 30251 30252 30253 30254 30255

EDMA Code

11 50 03 01 11 50 03 02 11 50 90 01 11 50 90 02 11 50 90 03 11 70 01 01 11 70 01 02 11 70 01 03 11 70 01 04 11 70 02 01 11 70 02 02 11 70 02 10 12 01 01 01 12 01 01 02 12 01 01 03 12 01 01 04 12 01 01 05 12 01 01 06 12 01 01 07 12 01 01 08 12 01 01 20 12 01 01 40 12 01 01 50 12 01 02 01 12 01 02 02 12 01 02 03 12 01 02 04 12 01 02 05 12 01 02 06 12 01 02 07 12 01 03 01 12 01 03 02 12 01 03 03 12 01 03 04 12 01 03 05 12 01 03 06 12 01 03 07 12 01 03 08 12 01 03 09 11 02 01 20

EDMA Term

Calibrators Multicomponent (CC) Calibrators Single Component (CC) Blood gas control Urine Control CSF controls Glucose Test Strips Cholesterol Test Strips HDL Test Strips Lactate Test Strips Urine Single Test Strips (incl. tablets) Urine Multi-Constituent Test Strips Urine SedimentTest Kit Immunoglobulin A Immunoglobulin A subclass reagents Immunoglobulin D Immunoglobulin D subclass reagents Immunoglobulin G Immunoglobulin G subclass reagents Immunoglobulin M Immunoglobulin M subclass reagents Kappa and Lambda chain Anti Human Ig polyvalent antisera Human anti-mouse antibody Complement Component C1q Complement Component C1 inactivator Complement Component C3/C3c Complement Component for Bb Complement Component C4 Complement Component C5a Complement Component C5-9 Albumin (IC) incl. uAlbumin CC =>11.02.01.01 Ceruloplasmin Haptoglobin Haemopexin Lactoferrin Pre-albumin / Transthyretin Retinol Binding Protein Transferrin Transcobalamin (S) Lipoprotein, Chemical determination/detection

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 18 of 108

GMDN Term

Apolipoprotein A-I kit Apolipoprotein A-II kit Apolipoprotein B kit Apolipoprotein E genotyping kit Atrial natriuretic peptide kit Creatine kinase-myoglobin kit Fatty acid binding protein (FABP) kit Glycogen phosphorylase BB kit Myoglobin kit Myosin light chain kit Troponin kit a1-acid glycoprotein Alpha1-antitrypsin kit Alpha2-macroglobulin kit Alpha1-microglobulin kit Fibronectin kit Trypsin kit Neonatal trypsin kit Antihistamine antibody kit Immunoglobulin E kit Immunoglobulin E specific, monotest/monoresult Immunoglobulin E monotest/monoresult multiantigen kit Immunoglobulin E monotest/pluriresult multiantigen kit Cancer antigen 15-3 kit Cancer antigen 19-9 kit Cancer antigen 50 kit Cancer antigen 72-4 kit Cancer antigen 125 kit Cancer antigen 195 kit Cancer antigen 242 kit Cancer antigen 549 kit Cytokeratin fragment 19 kit Carcinoembryonic antigen kit Mucin-like carcinoma-associated antigen kit Prostatic specific antigen Squamous cell carcinoma antigen kit Tissue polypeptide antigen kit Oestrogen receptor kit Progesterone receptor kit Alphafoetoprotein kit

GMDN Code

30256 30257 30258 30259 30260 30261 30262 30263 30264 30265 30266 30267 30268 30269 30270 30271 30272 30273 30274 30275 30276 30277 30278 30279 30280 30281 30282 30283 30284 30285 30286 30287 30288 30289 30290 30291 30292 30293 30294 30295

EDMA Code

12 01 04 01 12 01 04 02 12 01 04 03 12 01 04 11 12 13 01 01 12 70 13 01 12 13 01 03 12 13 01 04 12 13 01 05 12 13 01 06 12 13 01 07 12 01 90 01 12 01 90 02 12 01 90 03 12 01 90 04 12 01 90 05 12 01 90 07 12 01 90 08 12 10 90 90 12 02 01 02 12 02 01 03 12 02 01 04 12 02 01 05 12 03 01 02 12 03 01 03 12 03 01 04 12 03 01 05 12 03 01 06 12 03 01 07 12 03 01 08 12 03 01 09 12 03 01 20 12 03 01 31 12 03 01 90 12 03 01 32 12 03 01 35 12 03 01 36 12 03 02 01 12 03 02 02 12 03 90 01

EDMA Term

Apolipoprotein A I Apolipoprotein A II Apolipoprotein B Apolipoprotein E Genotyping Sub-typing GT=>16 01 02 03 00 Atrial- Brain Natriuric Peptide (incl. Pro-ANP/BNP) CK - MB / Myoglobin - Rapid Test Fatty Acid Binding Protein Glycogen Phosphorylase BB Myoglobin Myosin Light Chain Troponin (T + I) a1-Acid Glycoprotein ( Orosomucoid ) a1-Antitrypsin ( Protease inhibitor ) a2-Macroglobulin a1-Microglobulin Fibronectin Trypsin (IC) CC =>11.01.01.30 Trypsin Neonatal Other Other Auto-Immune Disease Tests Immunoglobulin E - Total Immunoglobulin E - Specific, monotest/monoresult Immunoglobulin E - monotest/monoresult - multi Ag Immunoglobulin E - monotest/pluriresult-multi Ag Cancer Antigen 15-3 Cancer Antigen 19-9 Cancer Antigen 50 Cancer Antigen 72-4 Cancer Antigen 125 Cancer Antigen 195 Cancer Antigen 242 Cancer Antigen 549 CYFRA 21-1 Carcinoembryonic Antigen Other Cancer Antigens Total Prostatic Specific Antigen Squamous Cell Carcinoma Antigen Tumor Polypeptide Antigen (TPA - incl. TPS) Estrogen Receptor Assays Progesterone Receptor Assays Alphafetoprotein

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 19 of 108

GMDN Term

Beta2-microglobulin kit Cathepsin-D kit 5-hydroxyindoleacetic acid kit Human placental alkaline phosphatase kit Laminin kit Neuron specific enolase kit Oncogene deoxyribonucleic acid probe kit Oncogene protein kit Prostatic acid phosphatase, IC Thymidine kinase kit Tissue-associated protein kit TPS Free triiodothyronine kit Free thyroxine kit Neonatal thyroid stimulating hormone kit Reverse triiodothyronine kit Triiodothyronine kit Triiodothyronine uptake kit Thyroxine kit Thyroglobulin kit Thyroxine binding globulin kit Thyroid peroxydase antibody kit Thyroid stimulating hormone kit Androstenedione kit Dehydroepiandrosterone kit Oestradiol kit Follicle stimulating hormone kit Progesterone kit 17-hydroxyprogesterone kit Prolactin kit Sex hormone binding globulin kit Testosterone kit Alpha2-pregnancy-associated glycoprotein kit Oestriol kit Free oestriol kit Oestrone kit Total human chorionic gonadotrophin kit Beta-human chorionic gonadotropin kit Human placental lactogen kit Pregnancy specific B1 glycoprotein kit

GMDN Code

30296 30297 30298 30299 30300 30301 30302 30303 30304 30305 30306 30307 30308 30309 30310 30311 30312 30313 30314 30315 30316 30317 30318 30319 30320 30321 30322 30323 30324 30325 30326 30327 30328 30329 30330 30331 30332 30333 30334 30335

EDMA Code

12 03 90 02 12 03 90 03 12 03 90 05 12 03 90 06 12 03 90 07 12 03 90 08 12 03 90 90 12 03 90 90 12 03 01 37 12 03 90 12 12 03 90 13 12 03 01 36 12 04 01 01 12 04 01 02 12 04 01 03 12 04 01 04 12 04 01 05 12 04 01 06 12 04 01 07 12 04 01 08 12 04 01 09 12 10 03 01 12 04 01 11 12 05 01 01 12 05 01 02 12 05 01 03 12 05 01 04 12 05 01 06 12 05 01 07 12 05 01 08 12 05 01 09 12 05 01 10 12 05 02 01 12 05 02 02 12 05 02 03 12 05 02 04 12 05 02 05 12 05 02 06 12 05 02 07 12 05 02 08

EDMA Term

Beta2-Microglobulin Cathepsin-D 5 HIAA Human Placenta Like Alkaline Phosphatase Laminin Neuron Specific Enolase Other Other Tumour Markers Other Other Tumour Markers Prostatic Acid Phosphatase (IC) CC =>11.01.01.02 Thymidine Kinase Tissue Associated Protein Tumor Polypeptide Antigen (TPA - incl. TPS) Free Triiodothyronine Free Thyroxine Neonatal Thyroid Stimulating Hormone Reverse Triiodothyronine Triiodothyronine T- Uptake Thyroxine Thyroglobulin Thyroid binding globulin Thyroid Peroxidase (incl. Microsomal) Antibodies Thyroid Stimulating Hormone Androstenedione Dehydro-epiandrosterone Sulphate (incl. DHEA) Estradiol Follicle Stimulating Hormone Progesterone 17 OH Progesterone Prolactin Sex Hormone Binding Globulin Testosterone (with Dehydro and Free Testosterone) Alpha2-Pregnancy Associated Glycoprotein Estriol Unconjugated (free) Estriol Estrone Human Chorionic Gonadotropin Total ß Human Chorionic Gonadotropin (incl. subunit) Human Placental Lactogen Pregnancy Specific B1 -glycoprotein

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 20 of 108

GMDN Term

C-peptide kit Glucagon kit Insulin kit Insulin antibody kit Glutamic acid decarboxylase II antibody/islet cell antibody kit Bone alkaline phosphate, IC Calcitonin kit Collagen type I C-terminal propeptide kit Collagen type III C-terminal propeptide kit Cross-linked C-telopeptide kit Cross-linked N-telopeptide kit Cyclic adenosine monophosphate kit Deoxypyridinoline kit Vitamin D kit, 1-25-dihydroxyvitamin D3 Vitamin D kit, 25-hydroxyvitamin D3 Hydroxyproline kit Osteocalcine kit Parathyroid hormone intact kit Parathyroid hormone fragment kit Parathyroid hormone-related peptide kit Pyridinoline kit Adrenocorticotropic hormone kit Human growth hormone kit Insulin-like growth factor I kit Insulin-like growth factor II kit Insulin-like growth factor binding protein 1 kit Insulin-like growth factor binding protein 3 kit Vasointestinal peptide kit Vasopressin kit Bombesin kit Beta-endorphin kit 17-hydroxyketosterone kit 17-ketogenic steroid kit 17-ketosteroid kit Melatonine kit Neopterine kit Oxytocin kit Pepsinogen kit Prostaglandin kit Serotonin uptake, platelet

GMDN Code

30336 30337 30338 30339 30340 30341 30342 30343 30344 30345 30346 30347 30348 30349 30350 30351 30352 30353 30354 30355 30356 30357 30358 30359 30360 30361 30362 30363 30364 30365 30366 30367 30368 30369 30370 30371 30372 30373 30374 30375

EDMA Code

12 06 01 01 12 06 01 02 12 06 01 03 12 06 01 04 12 06 01 05 12 06 03 01 12 06 03 02 12 06 03 03 12 06 03 04 12 06 03 05 12 06 03 06 12 06 03 07 12 06 03 08 12 06 03 09 12 06 03 10 12 06 03 11 12 06 03 12 12 06 03 13 12 06 03 14 12 06 03 15 12 06 03 16 12 06 04 01 12 06 04 02 12 06 04 03 12 06 04 04 12 06 04 05 12 06 04 06 12 06 04 07 12 06 04 08 12 06 05 01 12 06 05 02 12 06 05 03 12 06 05 04 12 06 05 05 12 06 90 06 12 06 90 07 12 06 90 08 12 06 90 09 12 06 90 10 12 06 90 11

EDMA Term

C-Peptide Glucagon Insulin Insulin Antibodies GAD II Antibodies and other ICA Bone Alkaline Phosphatase (IC) CC =>11.01.01.06 iso-AP Calcitonin Collagen Type I C-terminal Propeptide Collagen Type III C-terminal Propeptide Cross-Linked C-Telopeptides Cross-Linked N-Telopeptides Cyclic Adenosin Monophosphate Deoxypyridinoline 1.25 Dihydroxyvitamin D3 25-Hydroxyvitamin D3 Hydroxyproline Osteocalcine Parathyroid Hormone intact Parathyroid Hormone (C-/N-terminal, M-regional) Parathyroid Hormone related Peptide Pyridinoline Adrenocortiotropic Hormone Human Growth Hormone Insulin-like Growth Factor I (Somatomedin C) Insulin-like Growth Factor II Insulin-like Growth Factor Binding Protein 1 Insulin-like Growth Factor Binding Protein 3 Vasointestinal Peptide Vasopressin Bombesin ß-Endorphin 17-Hydroxy-Ketosterone 17-Ketogenic Steroids 17-Ketosteroids Melatonine Neopterine Oxytocin Pepsinogen Prostaglandin Serotonin-Uptake (Platelets)

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 21 of 108

GMDN Term

Erythropoietin kit Ferritin kit Folate kit Iron kit Iron binding capacity kit Vitamin B1 kit Vitamin B2 kit Vitamin B6 kit Vitamin B12 kit Vitamin D kit, cholecalciferol Digoxin kit Digitoxin kit Disopyramide kit Flecainide kit Lidocaine kit N-acetylprocainamide kit Procainamide kit Propranolol kit Quinidine kit Carbamazepine kit Ethosuximide kit Free carbamazepine kit Free phenytoin kit Free primodine kit Free valproic acid kit Phenobarbital kit Phenytoin kit Primidone kit Valproic acid kit Amikacin kit Chloramphenicol kit Dibekacin kit Gentamicin kit Kanamycin kit Netilmicin kit Sisomycin kit Streptomycin kit Tobramycin kit Vancomycin kit Teicoplanine kit

GMDN Code

30376 30377 30378 30379 30380 30381 30382 30383 30384 30385 30386 30387 30388 30389 30390 30391 30392 30393 30394 30395 30396 30397 30398 30399 30400 30401 30402 30403 30404 30405 30406 30407 30408 30409 30410 30411 30412 30413 30414 30415

EDMA Code

12 07 01 01 12 07 01 02 12 07 01 03 12 07 01 04 12 07 01 05 12 07 02 01 12 07 02 02 12 07 02 03 12 07 02 04 12 06 03 10 12 08 01 01 12 08 01 02 12 08 01 03 12 08 01 04 12 08 01 05 12 08 01 06 12 08 01 07 12 08 01 08 12 08 01 09 12 08 02 01 12 08 02 02 12 08 02 03 12 08 02 04 12 08 02 05 12 08 02 06 12 08 02 07 12 08 02 08 12 08 02 09 12 08 02 10 12 08 03 01 12 08 03 02 12 08 03 03 12 08 03 04 12 08 03 05 12 08 03 06 12 08 03 07 12 08 03 08 12 08 03 09 12 08 03 10 12 08 03 11

EDMA Term

Erythropoietin Ferritin Folate Iron (IC) CC =>11.02.01.16 Iron Binding Capacity - Total (IC) CC =>11.02.01.17 Vitamin B1 Vitamin B2 Vitamin B6 Vitamin B12 25-Hydroxyvitamin D3 Digoxin Digitoxin Disopyramide Flecainide Lidocaine N-Acetylprocainamide Procainamide Propranolol Quinidine Carbamazepine Ethosuximide Free Carbamazepine Free Phenytoin Free Primodine Free Valproic Acid Phenobarbital Phenytoin Primidone Valproic Acid Amikacin Chloramphenicol Dibekacin Gentamicin Kanamycin Netilmycin Sisomycin Streptomycin Tobramycin Vancomycin Teicoplanine

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 22 of 108

GMDN Term

Caffeine kit Theophylline kit Methotrexate kit Cyclosporine kit Cyclosporine specific Tacrolimus kit Amphetamine kit Amphetamine/methamphetamine specific +ecstasy Barbiturate kit Benzodiazepine kit Cannabinoid kit Cocaine/cocaine metabolite kit Codeine kit Cotinine/nocotine/nicotine kit Lysergic acid diethylamide kit Methadone kit Methaqualone kit Morphine kit Opiate kit Phencyclidine kit Propoxyphene kit Acetaminophene kit 5-aminolevulinate dehydratase kit Amitriptyline kit Catecholamine kit Desipramine kit Doxepin/doxepin metabolite kit Alcohol kit Hippuric acid kit Imipramine kit Nortriptyline kit Phenol kit Protoporphyrin kit Salicylate kit Trichloroacetic acid kit Tricyclic antidepressant kit Uro/coproporphyrin kit Vanilmandelic acid kit Antinuclear antibody kit Extractable nuclear antigen kit

GMDN Code

30416 30417 30418 30419 30420 30421 30422 30423 30424 30425 30426 30427 30428 30429 30430 30431 30432 30433 30434 30435 30436 30437 30438 30439 30440 30441 30442 30443 30444 30445 30446 30447 30448 30449 30450 30451 30452 30453 30454 30455

EDMA Code

12 08 04 01 12 08 04 02 12 08 05 01 12 08 06 01 12 08 06 02 12 08 06 03 12 09 01 01 12 09 01 02 12 09 01 03 12 09 01 04 12 09 01 05 12 09 01 06 12 09 01 07 12 09 01 08 12 09 01 09 12 09 01 10 12 09 01 11 12 09 01 12 12 09 01 13 12 09 01 14 12 09 01 15 12 09 02 01 12 09 02 02 12 09 02 03 12 09 02 04 12 09 02 05 12 09 02 06 12 09 02 07 12 09 02 08 12 09 02 09 12 09 02 10 12 09 02 11 12 09 02 12 12 09 02 13 12 09 02 14 12 09 02 15 12 09 02 16 12 09 02 17 12 10 01 01 12 10 01 02

EDMA Term

Caffeine Theophylline Methotrexate Cyclosporine Total Cyclosporine Specific Tacrolimus Amphetamines Group Amphetamine/Methamphetamine Specific (+Ecstasy) Barbiturates Benzodiazepines Cannabinoids Cocaine + Cocaine Metabolites Codeine Cotinine Lysergic acid diethylamide Methadone Methaqualone Morphines Opiates Phencyclidine Propoxyphene Acetaminophene (Paracetamol) 5-Aminolevulinate Dehydratase Amitriptyline Catecholamines Desipramine Doxepin plus metabolites Ethanol (Alcohol) Hippuric Acid Imipramine Nortriptyline Phenols Protoporphyrin IX Salicylate Trichloroacetic Acid Tricyclic Antidepressants (Total) Uro/Coproporphyrins Vanillylmandelic Acid ANA Screening ENA Screening

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 23 of 108

GMDN Term

Anticytoplasmic antibody kit CENP-antibody kit ds DNA, antibodies ss DNA, antibodies Histone kit Jo-1 antibody kit Polymyositis-scleroderma antibody kit Scleroderma-70 antibody kit U1-small nuclear ribonucleoprotein antibody kit Antiganglioside total antibody kit Anti-GM1 antibody kit Asialo-GM1 kit Anti-GD1b antibody kit GalNAc kit Antimyelin-associated glycoprotein kit Anti-cancer associated retinopathy kit Anti-Hu antibody kit Anti-Yo blood group antibody kit Anti-Ri antibody kit Anticardiolipin antibody kit Antimitochondrial antibody kit Antiphosphatidylserine antibody kit Anti-B2-glycoprotein I antibody kit Complement component C3b activation kit Gliadin antibody kit Goodpasture antibody kit Liver-kidney microsome 1/related protein antibody kit Myeloperoxidase antineutrophil cytoplasmic autoantibody kit Proteinase 3-antineutrophil cytoplasmic autoantibody kit Parietal cell antibody kit Sperm antibody kit Systemic lupus erythematosis kit Thyroid microsomal antibody kit Thyroid stimulating hormone receptor antibody kit Thyroglobulin autoantibody kit Antistreptococcal Dnase B kit Antistreptococcal hyaluronidase kit Antistreptokinase antibody kit Anti-streptolysin reaction/titre, quantitative Anti-streptolysin/anti-streptolysin O, qualitative

GMDN Code

30456 30457 30458 30459 30460 30461 30462 30463 30464 30465 30466 30467 30468 30469 30470 30471 30472 30473 30474 30475 30476 30477 30478 30479 30480 30481 30482 30483 30484 30485 30486 30487 30488 30489 30490 30491 30492 30493 30494 30495

EDMA Code

12 10 01 03 12 10 01 04 12 10 01 05 12 10 01 06 12 10 01 07 12 10 01 08 12 10 01 09 12 10 01 10 12 10 01 14 12 10 02 01 12 10 02 02 12 10 02 03 12 10 02 04 12 10 02 06 12 10 02 07 12 10 02 08 12 10 02 09 12 10 02 10 12 10 02 11 12 10 90 01 12 10 90 02 12 10 90 03 12 10 90 04 12 10 90 05 12 10 90 06 12 10 90 07 12 10 90 08 12 10 90 09 12 10 90 10 12 10 90 11 12 10 90 13 12 10 01 16 12 10 03 01 12 10 03 03 12 10 03 04 12 11 01 01 12 11 01 02 12 11 01 03 12 11 01 04 12 11 01 05

EDMA Term

Anti cytoplasmic - Antibodies CENP - Antibodies ds DNA - Antibodies ss DNA - Antibodies Histones (H1,H2a,H3,H4,...Hn) Jo-1 PM-Scl - Antibodies Scl-70 U1-snRNP - Antibodies Anti-Ganglioside-Antibodies Total Anti-GM1 Asialo-GM1 Anti-GD1b GalNAc Anti-MAG (Myelin Associated Glycoprotein) Anti-CAR (Cancer Associated Retinopathy) Anti-Hu Antibody Anti-Yo Antibody Anti-Ri Antibody Anti-Cardiolipin Antibodies Anti-Mitochondrial Antibodies Anti-Phosphatidylserin Antibodies Anti-ß2-Glycoprotein I Antibodies Complement Activation Gliadin Antibodies Goodpasture Antibodies LKM1 and Related Proteins Antibodies MPO ANCA PR3 ANCA Parietal Cell Antibodies Sperm Antibodies Systemic Lupus Erythematosus Thyroid Peroxidase (incl. Microsomal) Antibodies TSH Receptor Antibodies Thyroglobulin Autoantibodies Anti-Streptococcal D Nase B Anti-Streptococcal Hyaluronidase Anti-Streptokinase (ASK) Anti-Streptolysin (quantitative) Anti-Streptolysin/Anti-Streptolysin O (qualitative)

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 24 of 108

GMDN Term

Anti-staphylolysin reaction, quantitative Anti-staphylolysin, qualitative Circulating immune complex kit C-reactive protein kit Rheumatoid factor kit Monoethylglycinexylidide kit Drug calibrator Drug control Hormone calibrator Plasma protein calibrator Plasma protein control CK-MB/myoglobin rapid test Myoglobin rapid test Troponin T rapid test Bladder tissue antigen kit PSA rapid test FSH rapid test HCG rapid test HPL rapid test Luteinizing hormone self-testing device Amphetamine rapid test Barbiturate rapid test Benzodiazepine rapid test Cannabinoid rapid test Cocaine/cocaine metabolite rapid test Methadone rapid test Opiate rapid test Phencyclidine rapid test Tricyclic antidepressant rapid test Amanitin kit Reticulocyte kit Haemoglobin subtype kit Haematology stain for microscopy Cellular enzyme determination kit Glandular fever kit Haematology control/calibrator Control blood normal Control blood abnormal Control bood multilevel Haemoglobin kit

GMDN Code

30496 30497 30498 30499 30500 30501 30502 30503 30504 30505 30506 30507 30508 30509 30510 30511 30512 30513 30514 30515 30516 30517 30518 30519 30520 30521 30522 30523 30524 30525 30526 30527 30528 30529 30530 30531 30532 30533 30534 30535

EDMA Code

12 11 01 06 12 11 01 07 12 11 01 08 12 11 01 09 12 11 01 10 12 12 01 01 12 50 01 01 12 50 01 02 12 50 01 03 12 50 01 05 12 50 01 06 12 70 13 01 12 70 13 02 12 70 13 03 12 03 01 01 12 70 03 11 12 70 05 01 12 70 05 02 12 70 05 03 12 70 05 04 12 70 09 01 12 70 09 03 12 70 09 04 12 70 09 05 12 70 09 06 12 70 09 07 12 70 09 08 12 70 09 09 12 70 09 10 12 90 01 02 13 01 01 10 13 01 02 02 13 01 03 01 13 01 09 01 13 01 09 02 13 01 20 13 01 20 01 13 01 20 02 13 01 20 03 13 01 02 01

EDMA Term

Anti-Staphylolysin (qualititative) Anti-Staphylolysin (qualitative) Circulating Immune Complexes C-Reactive Protein IC=> 12 70 11 01 Rheumatoid Factors MEGX TDM/Drug Standards / Calibrators TDM/Drug Controls Hormone Standards / Calibrators Specific Protein Standards / Calibrators Specific Protein Controls CK - MB / Myoglobin - Rapid Test Myoglobin - Rapid Test Troponin I/T - Rapid Test Bladder Tissue Antigen PSA - Rapid Test FSH - Rapid Test HCG - Rapid Test HPL - Rapid Test LH - Rapid Test Amphetamines Group - Rapid Test Barbiturates - Rapid Test Benzodiazepines - Rapid Test Cannabinoids - Rapid Test Cocaine + Cocaine Metabolites - Rapid Test Methadone - Rapid Test Opiates - Rapid Test Phencyclidine - Rapid Test Tricyclic Antidepressants - Rapid Test Amanitin ( Organic poisons ) Specific Reticulocyte reagents Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Histo/Cyto stains Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Glandula fever Haematology Controls and Calibrators Control Blood Normal Control Blood Abnormal Control Blood Multilevel Haemoglobin determinations (Total Hb)

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 25 of 108

GMDN Term

Platelet control Reticulocyte control Whole blood calibrator Prothrombin time kit Thrombin time kit Fibrinogen kit Coagulation factor II kit Coagulation factor IIa kit Coagulation factor V kit Coagulation factor VII kit Coagulation factor VIIa kit Coagulation factor VIII kit Coagulation factor IX kit Coagulation factor X kit Coagulation factor II, VII, X kit Coagulation factor XI kit Coagulation factor XII kit Coagulation factor XIIa kit Coagulation factor XIII kit Coagulation factor XIIIa kit Coagulation factor XIIIs kit Coagulation factor high molecular weight (HMW) kininogen kit Coagulation factor von Willebrand kit Prekallikrein/kallikrein kit Activated protein C resistance kit Factor V Leiden kit Fibrin sensitivity monomer kit Fibrinopeptide A kit Heparin kit Hirudin test kit Plasmin-alpha2-antiplasmin complex kit Prothrombin fragment 1+2 kit Thrombin-antithrombin III-complex kit Aggregation reagents Platelet factor 4 kit Prostacyclin kit Thromboxane kit Beta-thromboglobulin kit Alpha2-antiplasmin kit Fibrinogen degradation product kit

GMDN Code

30536 30537 30538 30539 30540 30541 30542 30543 30544 30545 30546 30547 30548 30549 30550 30551 30552 30553 30554 30555 30556 30557 30558 30559 30560 30561 30562 30563 30564 30565 30566 30567 30568 30569 30570 30571 30572 30573 30574 30575

EDMA Code

13 01 20 05 13 01 20 06 13 01 20 07 13 02 01 01 13 02 01 03 13 02 02 01 13 02 02 02 13 02 02 03 13 02 02 04 13 02 02 05 13 02 02 06 13 02 02 07 13 02 02 08 13 02 02 09 13 02 02 90 13 02 02 11 13 02 02 12 13 02 02 13 13 02 02 14 13 02 02 90 13 02 02 90 13 02 02 17 13 02 02 18 13 02 02 19 13 02 06 11 13 02 02 04 13 02 03 03 13 02 03 04 13 02 03 05 13 02 03 06 13 02 03 07 13 02 03 08 13 02 03 09 13 02 04 01 13 02 04 02 13 02 04 03 13 02 04 04 13 02 04 05 13 02 05 01 13 02 05 02

EDMA Term

Platelet Control Reticulocyte Control Whole Blood Calibrators Prothrombin time ( Quick Test ) Thrombin Time / Reptilase / Batroxobin Time Fibrinogen Assays (Factor I) Coagulation factor II ( Prothrombin ) Coagulation factor II a ( Thrombin ) Coagulation factor V Coagulation factor VII Coagulation factor VII a Coagulation factor VIII Coagulation factor IX Coagulation factor X Other Coagulation Factors Coagulation factor XI Coagulation factor XII Coagulation factor XII a Coagulation factor XIII Other Coagulation Factors Other Coagulation Factors Coagulation factor HMW-Kininogen (Fitzgerald) Coagulation factor von Willebrand Antigen Prekallikrein / Kallikrein (Fletcher factor) APC Resistance Coagulation factor V Fibrin sensitivity monomer Fibrinopeptide A Heparin Hirudin Test Plasmin - a2 - Antiplasmin Complex Prothrombin Fragment 1 + 2 Thrombin-Antithrombin III-Complex Aggregation Factors Platelet Factor 4 Prostacyclin Thromboxane ß-Thromboglobulin a2-Antiplasmin Fibrinogen Degradation Products

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 26 of 108

GMDN Term

D-dimer kit Plasmin kit Plasminogen kit Plasminogen activator inhibitor kit Tissue plasminogen activator kit Urokinase plasminogen activator kit Antiphospholipid antibody kit Antithrombin III kit Coagulation factor VIII inhibitor kit Coagulation factor IX inhibitor kit Coagulation factor X inhibitor kit Lupus anticoagulant kit Protein C kit Protein S kit Plasma control Prothrombin time rapid test Calcium chloride Citrate test Haemostasis buffer kit ABO grouping cell kit ABO serum kit Rhesus phenotype kit Blood group antibody 2 cell screening kit Antibody 3 cell screening kit Antibody identification cell panel kit Polyspecific antihuman serum kit Monospecific antihuman serum kit Coombs control Immunohaematology control kit Complement for HLA testing kit Human leukocyte antigen antibody screening kit Human leukocyte antigen typing kit Human leukocyte antigen control cells kit Human leukocyte antigen nucleic acid kit B/T-cell subtyping antibody kit Human leukocyte antigen class II determinant antibody kit Lymphoma subtyping antibody kit Cell surface receptor recognizing antibody kit Leukaemia subtyping antibody kit Lymphocyte subtyping antibody kit

GMDN Code

30576 30577 30578 30579 30580 30581 30582 30583 30584 30585 30586 30587 30588 30589 30590 30591 30593 30594 30595 30596 30597 30598 30599 30600 30601 30602 30603 30604 30605 30606 30607 30608 30609 30610 30611 30612 30613 30614 30615 30616

EDMA Code

13 02 05 03 13 02 05 04 13 02 05 05 13 02 05 06 13 02 05 07 13 02 05 08 13 02 06 01 13 02 06 02 13 02 06 04 13 02 06 05 13 02 06 06 13 02 06 07 13 02 06 08 13 02 06 09 13 02 50 02 13 02 70 01 13 02 80 01 14 90 90 90 13 02 80 03 13 03 01 01 13 03 01 02 13 03 02 02 13 03 04 01 13 03 04 02 13 03 04 03 13 03 04 04 13 03 04 05 13 03 20 01 13 03 20 13 04 01 01 13 04 01 02 13 04 01 03 13 04 01 04 13 04 01 90 13 05 01 01 13 05 01 02 13 05 01 03 13 05 01 04 13 05 01 05 13 05 01 06

EDMA Term

D-Dimer Plasmin Plasminogen Plasminogen Activator-Inhibitors Tissue Plasminogen Activator Urokinase Plasminogen Activator Anti-Phospholipid Antibodies Antithrombin III Coagulation factor VIII Inhibitor Coagulation factor IX Inhibitor Coagulation factor X Inhibitor Lupus Anticoagulant Markers Protein C Protein S Control Plasmas Prothrombin Time Rapid Test Calcium Chloride Other Other Microbiology Tests Buffers (Haemostasis) ABO grouping cells ABO sera Rhesus Phenotypes Antibody 2 cell screening Antibody 3 cell screening Antibody identification cell panels Polyspecific antihuman serum Monospecific antihuman serum Coombs Control Cells Immunohaematology Controls Complement for HLA testing HLA Antibody screening HLA Antigen typing HLA Control Cells Other Tissue Typing Reagents Antibodies for B and T-cell subtyping Antibodies for HLA class II determinants Antibodies for lymphoma typing(except B-&T-cell typing) Antibodies for recognizing cell surface receptors Antibodies for subtyping of leukemia(except B-&T-cell typing) Antibodies for Lymphocyte subtyping

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 27 of 108

GMDN Term

Interferon a/B/y kit Interleukin IL-1/IL-12 kit Interleukin IL-1a/IL1b/IL1RA/IL2r/IL6r kit Tumour necrosis factor kit Chromosome culture kit Cytochemical staining reagent Deoxyribonucleic acid in situ hybridization kit Embedding medium Mounting medium, <specify> Stain powder, histology/cytology Stain solution, histology/cytology Immunohistologic kit Dehydrated culture medium, bacteriology DCM Susceptibility testing media, bacteriology, dehydrated DCM additive Prepared media in tubes, bacteriology Broth medium, tube Culture medium, Mycobacterium isolation Transport medium, tube Prepared media in bottles, bacteriology Agar medium for pouring, bottle Broth medium, bottle Enrichment medium, bottle Mycobacterium medium, bottle Culture medium, bacterial cultivation/identification Isolation medium, plate Substrate incorporated ID medium, plates Susceptibility test medium, plate Blood culture, manual Culture medium, blood, adult, automated Urine screening system, automated Urine screening, manual, strip Gram's stain Enterobacteriaceae, automated Biochemical identification kit, anaerobe, automated Enterobacteriaceae, manual Biochemical identification kit, anaerobe, manual Staphylococcus kit System, Mycoplasma (inc. combined with I.D.)

GMDN Code

30617 30618 30619 30620 30621 30622 30623 30624 30625 30626 30627 30628 30629 30630 30631 30632 30633 30634 30635 30636 30637 30638 30639 30640 30641 30642 30643 30644 30645 30646 30647 30648 30649 30650 30651 30652 30653 30654 30656 30657

EDMA Code

13 06 01 01 13 06 01 11 13 06 01 12 13 06 01 04 13 07 01 01 13 07 01 02 13 07 01 03 13 07 01 04 13 07 01 06 13 07 01 07 13 07 01 08 13 07 01 11 14 01 01 14 01 01 01 14 02 05 14 01 01 04 14 01 02 14 01 02 01 14 01 02 10 14 01 02 20 14 01 03 14 01 03 01 14 01 03 02 14 01 03 04 14 01 03 10 14 01 01 14 01 04 01 14 01 04 02 14 01 04 03 14 01 05 14 01 06 01 14 01 07 01 14 01 07 02 14 01 08 01 14 02 01 01 14 02 01 05 14 02 02 01 14 02 02 05 14 02 03 03 14 02 04 04

EDMA Term

Interferons (a,b,y) Interleukins (IL-1,IL-1A,IL-1B,.. - IL-15) Interleukins Receptors(IL-2R,IL6R ...) Tumour Necrosis Factors (TNFa,TNFb) Chromosome Culture Kits / reagents Cytochemical staining reagents DNA in situ Hybridisation reagents Embedding media (Histology/Cytology) Mounting media (Histology/Cytology) Stain powders (Histology/Cytology) Stain solutions (Histology/Cytology) Immunohistology kits Dehydrated Culture Media (Bacteriology) DCM (except susceptibility testing) Susceptibility Testing - Manual Additives for DCM Prepared Media in Tubes (Bacteriology) Broth Media (Tubes) Mycobacteria Isolation Media (Tubes) Transport Media (Tubes) Prepared Media in Bottles (Bacteriology) Agar Media for Pouring (Bottles) Broth Media (Bottles) Enrichment media (Bottles) Mycobacteria media (Bottles) Dehydrated Culture Media (Bacteriology) Isolation Media (Plates) Substrate Incorporated ID Media (Plates) Susceptibility Test Media (Plates) Blood Culture - Manual Adult Bottles (Blood Culture -Autom.) Urine Screening Systems - Automated Urine Screening Manual (Strips etc.) Gram's Stain Enterobacteriaceae - Automated Anaerobes - Automated Enterobacteriaceae - Manual Anaerobes - Manual Staphylococci Systems for Mycoplasma (inc. combined with I.D.)

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 28 of 108

GMDN Term

Mycobacterium susceptibility test kit Dehydrated culture medium, mycology DCM for yeasts/fungi Prepared medium in plates, mycology PPM for yeast/fungi Substrate incorporated medium for yeasts/fungi Culture medium, yeast/fungal cultivation/identification Tubed/bottled medium for yeasts/fungi Yeast kit Analyser, yeast/fungi Yeast/fungi nucleic acid kit Serological identification, yeast/fungi Tissue culture cell Culture medium, tissue Parasitology stain Pneumocystis carinii kit Plasmodium falciparum kit Cryptosporidium kit Chlamydia antigen kit Chlamydia nucleic acid kit Chlamydia total antibody kit Chlamydia immunoglobulin A kit Chlamydia immunoglobulin G kit Chlamydia immunoglobulin M kit Gonococcus antigen kit Gonococcus nucleic acid kit Gonococcus total antibody kit Treponema antigen kit Treponema nucleic acid kit Treponema total antibody kit Treponema immunoglobulin G kit Helicobacter pylori antigen kit Helicobacter pylori nucleic acid kit Helicobacter pylori antibody kit Legionella antigen kit Legionella nucleic acid kit Legionella antibody kit Borrelia antigen kit Borrelia nucleic acid kit Borrelia total antibody kit

GMDN Code

30658 30659 30660 30661 30662 30663 30664 30665 30666 30667 30668 30669 30670 30671 30672 30673 30674 30675 30676 30677 30678 30679 30680 30681 30682 30683 30684 30685 30686 30687 30688 30689 30690 30691 30692 30693 30694 30695 30696 30697

EDMA Code

14 02 05 04 14 03 01 14 03 01 01 14 03 02 14 03 02 01 14 03 02 02 14 03 04 03 14 03 03 14 03 04 01 24 09 10 01 15 06 01 90 14 03 05 01 14 04 01 01 14 04 01 02 14 05 01 02 14 05 02 01 14 05 02 02 14 05 02 03 15 01 01 01 15 01 01 40 15 01 01 03 15 01 01 04 15 01 01 05 15 01 01 06 15 01 02 01 15 01 02 40 15 01 02 03 15 01 03 01 15 01 03 40 15 01 03 03 15 01 03 05 15 01 04 01 15 01 04 40 15 01 04 03 15 01 05 01 15 01 05 40 15 01 05 03 15 01 06 01 15 01 06 40 15 01 06 03

EDMA Term

Mycobacteria Susceptibility Testing Dehydrated Culture Media (Mycology) DCM for Yeasts and Fungi Prepared Media in Plates (Mycology) PPM for Yeasts and Fungi Substrate Incorporated Media for Yeasts and Fungi Identification Systems for Yeasts and Fungi - Automated Tubes and Bottled Media for Yeasts and Fungi Identification Systems for Yeasts - Manual Other_MCB Hardware + dedicated accessories + software Other Mycology Immunoassays Serological Identification of Yeasts and Fungi Cells for Tissue Culture Media for Tissue Culture Parasitology Stains Pneumocystis carinii Plasmodium falciparum Cryptosporidium Chlamydia Antigen Detection Chlamydia Detection by NA Reagents Chlamydia Antibody Assays Total Chlamydia Antibody IgA Chlamydia Antibody IgG Chlamydia Antibody IgM Gonococcal Antigen Detection Gonococci detection by NA Reagents Gonococcal Antibody Assays Total Syphilis Antigen Detection Syphilis detection by NA Reagents Syphilis Antibody Assays Total Syphilis Antibody IgG H. Pylori Antigen Detection H. Pylori Detection by NA Reagents H. Pylori Antibody Assays Legionella Antigen Detection Legionella Detection by NA Reagents Legionella Antibody Assays Lyme Antigen Detection Lyme Detection by NA Reagents Lyme Antibody Total

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 29 of 108

GMDN Term

Mycobacterium antigen kit Mycobacterium nucleic acid kit Mycobacterium antibody kit Mycoplasma Mycoplasma antigen kit Mycoplasma nucleic acid kit Mycoplasma antibody kit Pseudomonas kit Pseudomonas aeruginosa antibody IgG Salmonella antigen kit Salmonella nucleic acid kit Salmonella antibody kit Streptococcus antigen kit Streptococcus nucleic acid kit Brucella kit Clostridium difficile kit Coxiella kit Leptospira kit Rickettsia kit Yersinia kit Hepatitis A virus antigen confirmatory kit Hepatitis A virus total antibody kit Hepatitis A virus immunoglobulin G kit Hepatitis A virus immunoglobulin M kit Hepatitis B virus surface antigen kit Hepatitis B virus surface antigen confirmatory kit Hepatitis B virus surface total antibody kit Hepatitis B virus surface immunoglobulin G kit Hepatitis B virus surface immunoglobulin M kit Hepatitis B virus core antigen kit Hepatitis B virus core antigen confirmatory kit Hepatitis B virus core nucleic acid kit Hepatitis B virus core total antibody kit Hepatitis B virus core immunoglobulin G kit Hepatitis B virus core immunoglobulin M kit Hepatitis B virus e antigen kit Hepatitis B virus e antigen confirmatory kit Hepatitis B virus e antigen nucleic acid kit Hepatitis B virus e antigen total antibody kit Hepatitis B virus e antibody immunoglobulin G kit

GMDN Code

30698 30699 30700 30701 30702 30703 30704 30705 30706 30707 30708 30709 30710 30711 30713 30714 30715 30716 30717 30718 30719 30720 30721 30722 30723 30724 30725 30726 30727 30728 30729 30730 30731 30732 30733 30734 30735 30736 30737 30738

EDMA Code

15 01 07 01 15 01 07 40 15 01 07 03 15 01 08 15 01 08 01 15 01 08 40 15 01 08 03 15 01 90 13 15 01 09 03 15 01 10 01 15 01 10 40 15 01 10 03 15 01 11 01 15 01 11 40 15 01 90 01 15 01 90 02 15 01 90 03 15 01 90 04 15 01 90 05 15 01 90 06 15 02 01 02 15 02 01 04 15 02 01 05 15 02 01 06 15 02 02 01 15 02 02 02 15 02 02 04 15 02 02 05 15 02 02 06 15 02 02 11 15 02 02 12 15 02 02 40 15 02 02 14 15 02 02 15 15 02 02 16 15 02 02 21 15 02 02 22 15 02 02 40 15 02 02 24 15 02 02 25

EDMA Term

Mycobacterial Antigen Detection Mycobacterial Detection by NA Reagents Mycobacterial Antibody Assays Mycoplasma Mycoplasma Antigen Detection Mycoplasma Detection by NA Reagents Mycoplasma Antibody Assays Pseudomonas Pseudomonas Aeruginosa Antibody IgG Salmonella Antigen Detection Salmonella Detection by NA Reagents Salmonella Antibody Assays Streptococcal Direct Antigen Detection Streptococci Detection by NA Reagents Brucella Clostridium difficile Coxiella Leptospira Rickettsia Yersinia HAV Antigen Confirmatory HAV Antibody (Total) HAV Antibody IgG HAV Antibody IgM Hepatitis B Surface Antigen Hepatitis B Surface Antigen - Confirmatory Hepatitis B Surface Antibody (Total) Hepatitis B Surface Antibody IgG Hepatitis B Surface Antibody IgM Hepatitis B Core Antigen Hepatitis B Core Antigen - Confirmatory Hepatitis B Virus - NA Reagents Hepatitis B Core Antibody (Total) Hepatitis B Core Antibody IgG Hepatitis B Core Antibody IgM Hepatitis Be Antigen Hepatitis Be Antigen - Confirmatory Hepatitis B Virus - NA Reagents Hepatitis Be Antibody (Total) Hepatitis Be Antibody IgG

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 30 of 108

GMDN Term

Hepatitis B virus e antibody immunoglobulin M kit Hepatitis C virus antigen kit Hepatitis C virus antigen confirmatory kit Hepatitis C virus nucleic acid kit Hepatitis C virus total antibody kit Hepatitis C virus immunoglobulin G kit Hepatitis C virus immunoglobulin M kit Hepatitis C virus antibody confirmatory kit Hepatitis D virus antigen kit Hepatitis D virus antigen confirmatory kit Hepatitis D virus nucleic acid kit Hepatitis D virus total antibody kit Hepatitis D virus immunoglobulin G kit Hepatitis D virus immunoglobulin M kit Hepatitis E virus antigen kit Hepatitis E virus antigen confirmatory kit Hepatitis E virus nucleic acid kit Hepatitis E virus total antibody kit Hepatitis E virus immunoglobulin G kit Hepatitis E virus immunoglobulin M kit Hepatitis G virus antigen kit Hepatitis G virus antigen confirmatory kit Hepatitis G virus nucleic acid kit Hepatitis G virus total antibody kit Hepatitis G virus immunoglobulin G kit Hepatitis G virus immunoglobulin M kit Human immunodeficiency virus I antibody kit Human immunodeficiency virus 1 antigen kit Human immunodeficiency virus 1 antigen confirmatory kit Human immunodeficiency virus 1 nucleic acid kit Human immunodeficiency virus 1 total antibody kit HIV 1 antibody IgG HIV 1 antibody IgM Human immunodeficiency virus 1 antibody confirmatory kit Human immunodeficiency virus 2 antibody kit Human immunodeficiency virus 2 antibody confirmatory kit Human immunodeficiency virus 1 antigen p24 kit Human immunodeficiency virus p24 antibody kit HIV - multiple (1/2) Human immunodeficiency virus multiple antigen kit

GMDN Code

30739 30740 30741 30742 30743 30744 30745 30746 30747 30748 30749 30750 30751 30752 30753 30754 30755 30756 30757 30758 30759 30760 30761 30762 30763 30764 30765 30766 30767 30768 30769 30770 30771 30772 30773 30774 30775 30776 30777 30778

EDMA Code

15 02 02 26 15 02 03 01 15 02 03 02 15 02 03 40 15 02 03 04 15 02 03 05 15 02 03 06 15 02 03 07 15 02 04 01 15 02 04 02 15 02 04 40 15 02 04 04 15 02 04 05 15 02 04 06 15 02 05 01 15 02 05 02 15 02 05 40 15 02 05 04 15 02 05 05 15 02 05 06 15 02 07 01 15 02 07 02 15 02 07 40 15 02 07 04 15 02 07 05 15 02 07 06 15 03 01 04 15 03 01 01 15 03 01 02 15 03 01 40 15 03 01 04 15 03 01 05 15 03 01 06 15 03 01 07 15 03 02 04 15 03 02 07 15 03 10 01 15 03 10 04 15 03 20 15 03 20 01

EDMA Term

Hepatitis Be Antibody IgM HCV Antigen HCV Antigen - Confirmatory Hepatitis C Virus - NA Reagents HCV Antibody (Total) HCV Antibody IgG HCV Antibody IgM HCV Antibody - Confirmatory Hepatitis Delta Antigen Hepatitis Delta Antigen - Confirmatory Hepatitis Delta Virus - NA Reagents Hepatitis Delta Antibody (Total) Hepatitis Delta Antibody IgG Hepatitis Delta Antibody IgM HEV Antigen HEV Antigen - Confirmatory Hepatitis E Virus - NA Reagents HEV Antibody (Total) HEV Antibody IgG HEV Antibody IgM HGV Antigen HGV Antigen - Confirmatory Hepatitis G Virus - NA Reagents HGV Antibody (Total) HGV Antibody IgG HGV Antibody IgM HIV 1 Antibody (Total) HIV 1 Antigen HIV 1 Antigen - Confirmatory HIV 1 - NA Reagents HIV 1 Antibody (Total) HIV 1 Antibody IgG HIV 1 Antibody IgM HIV 1 Antibody - Confirmatory HIV 2 Antibody HIV 2 Antibody - Confirmatory HIV P24 Antigen HIV P24 Antibody HIV - Multiple ( 1 / 2 ) HIV Multiple Antigen

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 31 of 108

GMDN Term

GMDN Code

30779 30780 30781 30782 30783 30784 30785 30786 30787 30788 30789 30790 30791 30792 30793 30794 30795 30796 30797 30798 30799 30800 30801 30802 30803 30804 30805 30806 30808 30809 30810 30811 30812 30813 30814 30815 30816 30817 30818 30819

EDMA Code

15 03 20 04 15 03 20 07 15 03 30 01 15 03 30 40 15 03 30 04 15 03 30 07 15 03 31 01 15 03 31 40 15 03 31 04 15 03 31 07 15 03 40 01 15 03 40 40 15 03 40 04 15 03 40 07 15 04 01 40 15 04 01 04 15 04 01 05 15 04 01 06 15 04 02 01 15 04 02 40 15 04 02 04 15 04 02 05 15 04 02 06 15 04 03 01 15 04 03 40 15 04 03 04 15 04 03 05 15 04 03 06 15 04 04 40 15 04 04 04 15 04 04 11 15 04 80 02 15 04 80 03 15 04 80 04 15 04 80 05 15 04 80 06 15 05 01 04 15 05 01 05 15 05 01 06 15 05 10 01

EDMA Term

HIV Multiple Antibody HIV Multiple Antibody - Confirmatory HTLV I Antigen HTLV I - NA Reagents HTLV I Antibody HTLV I Antibody - Confirmatory HTLV II Antigen HTLV II - NA Reagents HTLV II Antibody HTLV II Antibody - Confirmatory HTLV Multiple Antigen HTLV Multiple - NA Reagents HTLV Multiple Antibody HTLV Multiple Antibody - Confirmatory Rubella - NA Reagents Rubella Virus Antibodies - Total Rubella Virus IgG Rubella Virus IgM CMV Antigen CMV - NA Reagents CMV Antibodies - Total CMV IgG CMV IgM HSV Antigen HSV - NA Reagents HSV Antibodies - Total HSV IgG HSV IgM EBV - NA Reagents EBV Antibodies Mononucleosis Inf. Imm.=> 15 70 90 03 Enterovirus Human Papilloma Virus Influenza & Para Influenza Respiratory Syncytial Virus (RSV) Rotavirus Toxoplasma Antibody (Total) Toxoplasma Antibody IgG Toxoplasma Antibody IgM Entamoeba histolytica

Human immunodeficiency virus multiple antibody kit Human immunodeficiency virus multiple antibody confirmatory kit Human T-cell leukaemia virus I antigen kit Human T-cell leukaemia virus I nucleic acid kit Human T-cell leukaemia virus I antibody kit Human T-cell leukaemia virus I antibody confirmatory kit Human T-cell leukaemia virus II antigen kit Human T-cell leukaemia virus II nucleic acid kit Human T-cell leukaemia virus II antibody kit Human T-cell leukaemia virus II antibody confirmatory kit Human T-cell leukaemia virus multiple antigen kit Human T-cell leukaemia virus multiple antigen nucleic acid kit Human T-cell leukaemia virus multiple antibody kit Human T-cell leukaemia virus multiple antibody confirmatory kit Rubella virus nucleic acid kit Rubella virus total antibody kit Rubella virus immunoglobulin M kit Rubella virus immunoglobulin G kit Cytomegalovirus antigen kit Cytomegalovirus nucleic acid kit Cytomegalovirus total antibody kit Cytomegalovirus immunoglobulin G kit Cytomegalovirus immunoglobulin M kit Herpes simplex virus kit Herpes simplex virus nucleic acid kit Herpes simplex virus total antibody kit Herpes simplex virus immunoglobulin G kit Herpes simplex virus immunoglobulin M kit Epstein-Barr virus nucleic acid kit Epstein-Barr virus antibody kit Mononucleosis Enterovirus kit Human papillomavirus kit Influenza/parainfluenza kit Respiratory syncytial virus kit Rotavirus kit Toxoplasma total antibody kit Toxoplasma immunoglobulin G kit Toxoplasma immunoglobulin M kit Entamoeba kit

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 32 of 108

GMDN Term

Chagas Distoma kit Echinococcus kit Leishmania kit Schistosoma kit H. Pylori rapid test Strep A rapid test Strep B rapid test Treponema rapid test kit Hepatitis virus rapid test kit HBsAg rapid test HCV antibody rapid test Human immunodeficiency virus rapid test kit HIV 1/2 rapid test Cytomegalovirus rapid test kit Clinical chemistry instrument Chemistry analyser Manual photometer/spectrophotometer Dedicated glycated haemoglobin/HbA1system Semi-automated CC analyser Small automated CC analyser Medium automated CC analyser Large automated CC analyser Extra large automated CC analyser Electrolyte, flame photometer Blood gas analyser Blood gas, p02/pC02, pH Analyser, blood gas, general-purpose Blood gas/CO-oximeter Blood gas, electrolyte, CO-oximeter Laboratory equipment, electrophoresis Urine analyser Manual urine analyser Glucose meter, self-testing Analyser, cholesterol Immunochemistry instrument Analyser, protein Protein analyser Large protein analyser Analyser, immunoassay, <specify>

GMDN Code

30820 30821 30822 30823 30824 30825 30826 30827 30828 30829 30830 30831 30832 30833 30834 30835 30836 30837 30838 30839 30840 30841 30842 30843 30844 30845 30846 30847 30848 30849 30851 30852 30853 30854 30855 30856 30857 30858 30859 30860

EDMA Code

15 05 10 02 15 05 10 03 15 05 10 04 15 05 10 05 15 05 10 06 15 70 01 02 15 70 01 03 15 70 01 04 15 70 01 05 15 70 02 15 70 02 01 15 70 02 02 15 70 03 15 70 03 02 15 70 90 01 21 01 10 01 21 01 10 01 21 01 10 01 21 07 10 09 21 01 10 01 21 01 10 01 21 01 10 01 21 01 10 01 21 01 10 01 21 04 10 01 21 04 10 01 21 04 10 01 21 04 10 01 21 04 10 01 21 04 10 01 21 05 10 01 21 01 10 01 21 01 10 01 21 07 10 01 21 01 10 01 21 02 10 01 21 02 10 01 21 02 10 01 21 02 10 01 21 02 10 01

EDMA Term

Chagas Distomatosis Echinococcus Leishmania Schistosoma H. Pylori - Rapid Test Strep A - Rapid Test Strep B - Rapid Test Syphilis - Rapid Test Hepatitis Viruses Rapid Tests HBsAg - Rapid Test HCV Antibody - Rapid Test Retroviruses Rapid Test HIV 1 / 2 - Rapid Test CMV - Rapid Test CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software Other RT_CI Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software EP Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software Diabetes Management Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 33 of 108

GMDN Term

2/3 part differential blood cell counter 5 part differential low/medium end blood cell counter Analyser, haematology, reticulocyte Flow cytometer without cell sorter Flow cytometer with cell sorter Fully-automated coagulation system Sedimentation rate instrument, manual Blood culture system Clinical centrifuge Sample processor, immunoassay Bacteria culture media/equipment Analyser, gas, nitrogen, partial pressure Fletcher factor Zimmerman/Norymberski, 17-ketogenic steroid Nitrous/nitrosonaphthol acid kit, 5-hydroxyindole Porter silber hydrazone, 17-hydroxycorticosteroid L-leucyl B-naphthylamide, leucine aminopeptidase Radioassay, vitamin B12 Chromatographic separation/Zimmerman, 17-ketosteroid Acid, vanilmandelic, diazo, p-nitroaniline/vanillin Acid, uric, phosphotungstate reduction Acid, vanilmandelic, electrophoretic separation Berthelot indophenol, urea nitrogen Urobilinogen kit Urease, photometric, urea nitrogen Radioimmunoassay, total triodothyronine Free tyrosine kit Electrode, ion specific, urea nitrogen Diacetyl-monoxime, urea nitrogen Radioimmunoassay, total thyroxine Radioimmunoassay, testosterone Radioimmunoassay, free thyroxine Radioimmunoassay, thyroxine-binding globulin Analyser, electrophoresis, protein fractionation Uranyl acetate/zinc acetate, sodium Tetraphenyl borate, colorimetry, potassium Electrode, ion specific, potassium Urinary pH dye-indicator kit Molybdenum blue method, phospholipids 2,4-dinitrophenylhydrazine, lactate dehydrogenase

GMDN Code

30861 30862 30863 30864 30865 30866 30867 30868 30869 30870 30891 31240 31337 31345 31346 31347 31348 31349 31350 31351 31352 31353 31354 31355 31356 31357 31358 31359 31360 31361 31362 31363 31364 31365 31366 31367 31368 31369 31370 31371

EDMA Code

23 01 10 01 23 01 10 01 23 01 10 01 23 04 10 01 23 04 10 01 23 02 10 01 23 09 10 01 24 02 10 01 28 01 10 01 28 01 10 01 24 09 10 01 00 00 00 00 13 02 02 19 12 06 05 04 12 03 90 05 12 06 05 03 11 01 01 22 12 07 02 04 12 06 05 04 12 09 02 17 11 02 01 32 12 09 02 17 11 02 01 04 11 70 02 01 11 02 01 04 12 04 01 05 12 06 90 90 11 04 03 05 11 02 01 04 12 04 01 07 12 05 01 10 12 04 01 02 12 04 01 09 21 05 10 01 11 03 01 10 11 03 01 09 11 03 01 09 11 70 02 01 11 02 01 24 11 01 01 19

EDMA Term

CC Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software FC Hardware + dedicated accessories + software FC Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software Other_HHC Hardware + dedicated accessories + software BC & MB Hardware + dedicated accessories + software SP Hardware + accessories + software SP Hardware + accessories + software Other_MCB Hardware + dedicated accessories + software Not for IVD use Prekallikrein / Kallikrein (Fletcher factor) 17-Ketogenic Steroids 5 HIAA 17-Hydroxy-Ketosterone Leucine Aminopeptidase Vitamin B12 17-Ketogenic Steroids Vanillylmandelic Acid Uric Acid Vanillylmandelic Acid Urea/Blood Urea Nitrogen Urine Single Test Strips (incl. tablets) Urea/Blood Urea Nitrogen Triiodothyronine Other Individual and Specified Hormones Urea - Electrodes Urea/Blood Urea Nitrogen Thyroxine Testosterone (with Dehydro and Free Testosterone) Free Thyroxine Thyroid binding globulin EP Hardware + dedicated accessories + software Sodium Potassium Potassium Urine Single Test Strips (incl. tablets) Phospholipids Lactate Dehydrogenase L ( LDH - L --> P )

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 34 of 108

GMDN Term

Phenylketone kit Radioimmunoassay, parathyroid hormone Electrode, ion specific, magnesium Chromatographic derivative, total lipids Sulfophosphovanillin, colorimetry, total lipids Electrophoretic, lactate dehydrogenase isoenzymes Tetrazolium INT dye-diaphorase, lactate dehydrogenase NAD reduction/NADH oxidation, lactate dehydrogenase Radioimmunoassay, human growth hormone Titrimetric, magnesium Radioimmunoassay, immunoreactive insulin Hexokinase, glucose Radioimmunoassay, prolactin (lactogen) Copper reduction, glucose Glucose oxidase, glucose Ferricyanide, glucose Orthotoluidine, glucose Globulin kit Radioimmunoassay, estriol Electrode, ion based, enzymatic, creatinine Acid, folic, radioimmunoassay Lieberman-Burchard/Abell-Kendall, colorimetric, cholesterol Radioimmunoassay, cortisol Cyclic glutamate monophosphate kit Alkaline picrate, colorimetry, creatinine Radioimmunoassay, corticosterone Acid, ferric ion-sulfuric, cholesterol Radioimmunoassay, corticoids Acid, phosphoric-thungstic (spectrophotometric), chloride Mercuric thiocyanate, colorimetry, chloride Immunochemical, ceruloplasmin Radioimmunoassay, cyclic AMP Radioimmunoassay, estradiol Chromatographic/fluorometric method, catecholamines Titrimetric phenol red, carbon-dioxide Bicarbonate/carbon dioxide kit, coulometric method Electrophoretic method, catecholamines Methylthymol blue, calcium Angiotensin I/renin kit Cresolphthalein complexone, calcium

GMDN Code

31372 31373 31374 31375 31376 31377 31378 31379 31380 31381 31382 31383 31384 31385 31386 31387 31388 31389 31390 31391 31392 31393 31394 31395 31396 31397 31398 31399 31400 31401 31402 31403 31404 31405 31406 31407 31408 31409 31410 31411

EDMA Code

11 02 01 36 12 06 03 14 11 04 01 05 11 02 01 28 11 02 01 28 11 01 01 21 11 01 01 19 11 01 01 19 12 06 04 02 11 03 01 07 12 06 01 03 11 02 01 13 12 05 01 08 11 02 01 13 11 02 01 13 11 02 01 13 11 02 01 13 11 02 01 30 12 05 02 02 11 04 03 01 12 07 01 03 11 02 01 05 12 06 02 04 12 06 90 90 11 02 01 07 12 05 01 15 11 02 01 05 12 05 01 15 11 03 01 04 11 03 01 04 12 01 03 02 12 06 03 07 12 05 01 03 12 09 02 04 11 03 01 02 11 03 01 02 12 09 02 04 11 03 01 03 12 06 02 02 11 03 01 03

EDMA Term

Phenylketonuria Parathyroid Hormone (C-/N-terminal, M-regional) Magnesium - Electrodes Total Lipids Total Lipids Lactate Dehydrogenase Isoenzymes Lactate Dehydrogenase L ( LDH - L --> P ) Lactate Dehydrogenase L ( LDH - L --> P ) Human Growth Hormone Magnesium Insulin Glucose Prolactin Glucose Glucose Glucose Glucose Total Protein Estriol Creatinine - Electrodes Folate Cholesterol Cortisol Other Individual and Specified Hormones Creatinine Corticosteron (R/M) Cholesterol Corticosteron (R/M) Chloride Chloride Ceruloplasmin Cyclic Adenosin Monophosphate Estradiol Catecholamines Bicarbonate Bicarbonate Catecholamines Calcium Angiotensin I / II Calcium

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 35 of 108

GMDN Term

Vanillin pyruvate, AST/SGOT Diazo colorimetry, bilirubin Saccharogenic, amylase Radial diffusion, amylase Cresol red colorimetry, carbon-dioxide Diazo, AST/SGOT Hydrazone colorimetry, AST/SGOT NADH oxidation/NAD reduction, AST/SGOT Starch-dye bound polymer, amylase Androsterone kit Radioimmunoassay, androstenedione Amyloclastic, amylase Nitrosalicylate reduction, amylase Tetrabromophenolphthalein, albumin Tetrabromo-m-cresolsulfonphthalein, albumin Diazo, ALT/SGPT Aldosterone kit Acid phosphatase, nitrophenylphosphate Radial immunodiffusion, albumin Acid phosphatase, thymol blue monophosphate Hydrazone colorimetry, aldolase Bromcresol purple dye-binding, albumin Azo dye, calcium Acid, hydroxyazobenzene-benzoic, albumin NADH oxidation/NAD reduction, ALT/SGPT Acid phosphatase, naphthyl phosphate Hydrazone colorimetry, ALT/SGPT Acid phosphatase, beta glycerophosphate IgD, antigen, antiserum, control IgA, rhodamine, antigen, antiserum, control IgA, peroxidase, antigen, antiserum, control IgA, ferritin, antigen, antiserum, control IgA, FITC, antigen, antiserum, control Inter-alpha-trypsin inhibitor kit IgA, antigen, antiserum, control Bence-Jones protein control Retinol-binding protein, antigen, antiserum, control Complement component C3/C3c control Complement component C1s control Haptoglobin, rhodamine, antigen, antiserum, control

GMDN Code

31412 31413 31414 31415 31416 31417 31418 31419 31420 31421 31422 31423 31424 31425 31426 31427 31428 31429 31430 31431 31432 31433 31434 31435 31436 31437 31438 31439 31440 31441 31442 31443 31444 31445 31446 31447 31448 31449 31450 31451

EDMA Code

11 01 01 10 11 02 01 03 11 01 01 07 11 01 01 07 11 03 01 02 11 01 01 10 11 01 01 10 11 01 01 10 11 01 01 07 12 05 01 11 12 05 01 01 11 01 01 07 11 01 01 07 11 02 01 01 11 02 01 01 11 01 01 03 12 06 02 01 11 01 01 02 12 01 03 01 11 01 01 02 11 01 01 04 11 02 01 01 11 03 01 03 11 02 01 01 11 01 01 03 11 01 01 02 11 01 01 03 11 01 01 02 12 01 01 03 12 01 01 01 12 01 01 01 12 01 01 01 12 01 01 01 12 01 90 02 12 01 01 01 12 50 01 06 12 50 01 06 12 50 01 06 12 50 01 06 12 01 03 03

EDMA Term

Aspartate Amino-Transferase Bilirubin Amylase - Total Amylase - Total Bicarbonate Aspartate Amino-Transferase Aspartate Amino-Transferase Aspartate Amino-Transferase Amylase - Total Androsterone Androstenedione Amylase - Total Amylase - Total Albumin (CC) Albumin (CC) Alanine Amino-Transferase Aldosterone Acid Phosphatase (CC) Albumin (IC) incl. uAlbumin Acid Phosphatase (CC) Aldolase Albumin (CC) Calcium Albumin (CC) Alanine Amino-Transferase Acid Phosphatase (CC) Alanine Amino-Transferase Acid Phosphatase (CC) Immunoglobulin D Immunoglobulin A Immunoglobulin A Immunoglobulin A Immunoglobulin A a1-Antitrypsin ( Protease inhibitor ) Immunoglobulin A Specific Protein Controls Specific Protein Controls Specific Protein Controls Specific Protein Controls Haptoglobin

IC =>12.01.03.01 IC =>12.01.03.01

IC => 12.03.01.37 CC =>11.02.01.01 IC => 12.03.01.37 IC =>12.01.03.01 IC =>12.01.03.01 IC => 12.03.01.37 IC => 12.03.01.37

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 36 of 108

GMDN Term

IgG, peroxidase, antigen, antiserum, control Haptoglobin, FITC, antigen, antiserum, control Complement C3b activator, antigen, antiserum, control Haptoglobin, antigen, antiserum, control Complement component C9 control Gamma globulin, FITC, antigen, antiserum, control Complement component C8 control Gamma globulin, antigen, antiserum, control Complement component C1r control Complement component C1q control Fraction IV-5, antigen, antiserum, control Fibrinopeptide A, antigen, antiserum, control Alpha2-AP-glycoprotein control Complement component C5 control Complement component C1 inactivator control Alpha2-2N-glycoprotein control Anti-smooth muscle antibody control Ferritin, antigen, antiserum, control FC, rhodamine, antigen, antiserum, control Complement component C4 control Antiparietal cell antibody control FC, FITC, antigen, antiserum, control FC, antigen, antiserum, control Coagulation factor XIIIa/XIIIs control Fab, rhodamine, antigen, antiserum, control Fab, FITC, antigen, antiserum, control Fab, antigen, antiserum, control Albumin, antigen, antiserum, control System, test, C-reactive protein, rhodamine Beta-globulin control System, test, C-reactive protein Alpha-globulin control Ceruloplasmin, rhodamine, antigen, antiserum, control Ceruloplasmin, FITC, antigen, antiserum, control Ceruloplasmin, antigen, antiserum, control Thyroglobulin, antigen, antiserum, control Transferrin, rhodamine, antigen, antiserum, control Carbonic anhydrase C, antigen, antiserum, control Prothrombin, antigen, antiserum, control Transferrin, antigen, antiserum, control

GMDN Code

31452 31453 31454 31455 31456 31457 31458 31459 31460 31461 31462 31463 31464 31465 31466 31467 31468 31469 31470 31471 31472 31473 31474 31475 31476 31477 31478 31479 31480 31481 31482 31483 31484 31485 31486 31487 31488 31489 31490 31491

EDMA Code

12 01 01 05 12 01 03 03 12 01 02 03 12 01 03 03 12 50 01 06 12 01 01 05 12 50 01 06 12 01 01 05 12 50 01 06 12 50 01 06 12 01 01 90 13 02 03 04 12 50 01 06 12 50 01 06 12 50 01 06 12 50 01 06 12 50 01 14 12 07 01 02 12 01 01 90 12 50 01 06 12 50 01 14 12 01 01 90 12 01 01 90 13 02 50 90 12 01 01 90 12 01 01 90 12 01 01 90 12 01 03 01 12 11 01 09 12 50 01 06 12 11 01 09 12 50 01 06 12 01 03 02 12 01 03 02 12 01 03 02 12 04 01 08 12 01 03 08 12 01 90 90 13 02 01 01 12 01 03 08

EDMA Term

Immunoglobulin G Haptoglobin Complement Component C3/C3c Haptoglobin Specific Protein Controls Immunoglobulin G Specific Protein Controls Immunoglobulin G Specific Protein Controls Specific Protein Controls Other Immunoglobulins Fibrinopeptide A Specific Protein Controls Specific Protein Controls Specific Protein Controls Specific Protein Controls Rheumatoid/Autoimmune Controls Ferritin Other Immunoglobulins Specific Protein Controls Rheumatoid/Autoimmune Controls Other Immunoglobulins Other Immunoglobulins Other Haemostasis Controls Other Immunoglobulins Other Immunoglobulins Other Immunoglobulins Albumin (IC) incl. uAlbumin CC =>11.02.01.01 C-Reactive Protein IC=> 12 70 11 01 Specific Protein Controls C-Reactive Protein IC=> 12 70 11 01 Specific Protein Controls Ceruloplasmin Ceruloplasmin Ceruloplasmin Thyroglobulin Transferrin Other Other Plasma Proteins Prothrombin time ( Quick Test ) Transferrin

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 37 of 108

GMDN Term

Carbonic anhydrase control Transferrin, FITC, antigen, antiserum, control Thyroglobulin, FITC, antigen, antiserum, control Beta2-glycoprotein III control Thyroglobulin, rhodamine, antigen, antiserum, control Beta2-glycoprotein I control Myoglobin, rhodamine, antigen, antiserum, control Antigen, antiserum, control, antithrombin III Myoglobin, antigen, antiserum, control Prealbumin, FITC, antigen, antiserum, control Albumin, FITC, antigen, antiserum, control Myoglobin, FITC, antigen, antiserum, control Inter-alpha-trypsin inhibitor control Alpha2-HS-glycoprotein control Lactoferrin, antigen, antiserum, control Lambda, antigen, antiserum, control Alpha-1-antitrypsin, FITC, antigen, antiserum, control Alpha2-glycoprotein control Kappa, rhodamine, antigen, antiserum, control Lipoprotein X, antigen, antiserum, control Alpha-1-antitrypsin, antigen, antiserum, control Alpha1-T-glycoprotein control Kappa, FITC, antigen, antiserum, control Lambda, peroxidase, antigen, antiserum, control Alpha1-lipoprotein control Lambda, FITC, antigen, antiserum, control Lactic dehydrogenase, antigen, antiserum, control IgG, antigen, antiserum, control Alpha1-B-glycoprotein control IgM, peroxidase, antigen, antiserum, control IgM, rhodamine, antigen, antiserum, control Lipoprotein control Kappa, peroxidase, antigen, antiserum, control Alpha1-antichymotrypsin control Lambda, rhodamine, antigen, antiserum, control Kappa, antigen, antiserum, control Spinal fluid control Albumin, rhodamine, antigen, antiserum, control IgM, ferritin, antigen, antiserum, control IgE, ferritin, antigen, antiserum, control

GMDN Code

31492 31493 31494 31495 31496 31497 31498 31499 31500 31501 31502 31503 31504 31505 31506 31507 31508 31509 31510 31511 31512 31513 31514 31515 31516 31517 31518 31519 31520 31521 31522 31523 31524 31525 31526 31527 31528 31529 31530 31531

EDMA Code

12 50 01 06 12 01 03 08 12 04 01 08 12 50 01 14 12 04 01 08 12 50 01 14 12 13 01 05 13 02 06 02 12 13 01 05 12 01 03 06 12 01 03 01 12 13 01 05 12 50 01 06 12 50 01 06 12 50 01 06 12 01 01 20 12 01 90 02 12 50 01 06 12 01 01 20 12 01 04 90 12 01 90 02 12 50 01 06 12 01 01 20 12 01 01 20 12 50 01 06 12 01 01 20 11 01 01 19 12 01 01 05 12 50 01 06 12 01 01 07 12 01 01 07 12 50 01 06 12 01 01 20 12 50 01 06 12 01 01 20 12 01 01 20 11 50 90 03 12 01 03 01 12 01 01 07 12 02 01 02

EDMA Term

Specific Protein Controls Transferrin Thyroglobulin Rheumatoid/Autoimmune Controls Thyroglobulin Rheumatoid/Autoimmune Controls Myoglobin Antithrombin III Myoglobin Pre-albumin / Transthyretin Albumin (IC) incl. uAlbumin CC =>11.02.01.01 Myoglobin Specific Protein Controls Specific Protein Controls Specific Protein Controls Kappa and Lambda chain a1-Antitrypsin ( Protease inhibitor ) Specific Protein Controls Kappa and Lambda chain Other Lipoproteins a1-Antitrypsin ( Protease inhibitor ) Specific Protein Controls Kappa and Lambda chain Kappa and Lambda chain Specific Protein Controls Kappa and Lambda chain Lactate Dehydrogenase L ( LDH - L --> P ) Immunoglobulin G Specific Protein Controls Immunoglobulin M Immunoglobulin M Specific Protein Controls Kappa and Lambda chain Specific Protein Controls Kappa and Lambda chain Kappa and Lambda chain CSF controls Albumin (IC) incl. uAlbumin CC =>11.02.01.01 Immunoglobulin M Immunoglobulin E - Total

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 38 of 108

GMDN Term

IgG, rhodamine, antigen, antiserum, control Sperm, antigen, antiserum, control IgM, FITC, antigen, antiserum, control IgM, antigen, antiserum, control Cohn fraction II, antigen, antiserum, control Seminal fluid control IgE, antigen, antiserum, control IgG, ferritin, antigen, antiserum, control IgD, rhodamine, antigen, antiserum, control IgD, FITC, antigen, antiserum, control IgD, peroxidase, antigen, antiserum, control Breast milk control Colostrum control IgG, FITC, antigen, antiserum, control IgE, rhodamine, antigen, antiserum, control Breast milk, antigen, antiserum, control Breast milk, FITC, antigen, antiserum, control IgE, peroxidase, antigen, antiserum, control IgE, FITC, antigen, antiserum, control System, test, systemic lupus erythematosus System, test, rheumatoid factor Drug mixture control material Cholinesterase test strip Colorimetry, cholinesterase Thin layer chromatography, quinine Radioimmunoassay, primidone Gas chromatography, salicylate Gas chromatography, cocaine Enzyme immunoassay, diphenylhydantoin Free radical assay, cocaine Enzyme immunoassay, barbiturate Thin layer chromatography, amphetamine Thin layer chromatography, phenobarbital Gas chromatography, ethosuximide Delayed analysis, alcohol Metamphetamine kit Enzyme immunoassay, primidone Thin layer chromatography, salicylate Gas chromatography, opiates Enzyme immunoassay, opiates

GMDN Code

31532 31533 31534 31535 31536 31537 31538 31539 31540 31541 31542 31543 31544 31545 31546 31547 31548 31549 31550 31554 31555 31556 31557 31558 31559 31560 31561 31562 31563 31564 31565 31566 31567 31568 31569 31570 31571 31572 31573 31574

EDMA Code

12 01 01 05 12 05 01 90 12 01 01 07 12 01 01 07 12 01 01 05 12 50 01 06 12 02 01 02 12 01 01 05 12 01 01 03 12 01 01 03 12 01 01 03 12 50 01 06 12 50 01 04 12 01 01 05 12 02 01 02 12 01 90 90 12 01 90 90 12 02 01 02 12 02 01 02 12 10 01 16 12 11 01 10 12 50 01 02 11 70 01 90 11 01 01 11 12 08 01 09 12 08 02 09 12 09 02 13 12 09 01 06 12 08 02 90 12 09 01 06 12 09 01 03 12 09 01 01 12 08 02 07 12 08 02 02 12 09 02 07 12 09 01 02 12 08 02 09 12 09 02 13 12 09 01 13 12 09 01 13

EDMA Term

Immunoglobulin G Other Fertility Function Hormones Immunoglobulin M Immunoglobulin M Immunoglobulin G Specific Protein Controls Immunoglobulin E - Total Immunoglobulin G Immunoglobulin D Immunoglobulin D Immunoglobulin D Specific Protein Controls Hormone Controls Immunoglobulin G Immunoglobulin E - Total Other Other Plasma Proteins Other Other Plasma Proteins Immunoglobulin E - Total Immunoglobulin E - Total Systemic Lupus Erythematosus Rheumatoid Factors TDM/Drug Controls Other Blood Test Strips Cholinesterase Quinidine Primidone Salicylate Cocaine + Cocaine Metabolites Other Central Nervous System TDM Cocaine + Cocaine Metabolites Barbiturates Amphetamines Group Phenobarbital Ethosuximide Ethanol (Alcohol) Amphetamine/Methamphetamine Specific (+Ecstasy) Primidone Salicylate Opiates Opiates

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 39 of 108

GMDN Term

Gas chromatography, phenobarbital Antiserum, gentamicin Digitoxin control serum, RIA Free radical assay, amphetamine Test reagent, zinc Mercury dithiazone, colorimetry, barbiturate Radioimmunoassay, amphetamine Phenothiazine kit Enzyme immunoassay, methadone Chloral hydrate kit Radioimmunoassay, ethosuximide Device, breath trapping, alcohol Antiserum, digoxim Calibrator, drug mixture Alcohol control material Reagent, test, tetrahydrocannabinol Gas chromatography, diphenylhydantoin Colorimetry, salicylate Radioimmunoassay, barbiturate Radioimmunoassay, phenobarbital Antiserum, digitoxin Thin layer chromatography, methadone Free radical assay, opiates Sulphanimide derivative kit Thin layer chromatography, barbiturate Enzyme immunoassay, amphetamine Thin layer chromatography, codeine Bromide kit Enzyme immunoassay, ethosuximide Gas chromatography, alcohol Acetylcholine choride, specific reagent, pseudo cholinesterase Calibrator, drug specific Haemagglutination, cocaine Radioimmunoassay, diphenylhydantoin Enzyme immunoassay, phenobarbital Gas chromatography, methadone Gas liquid chromatography, barbiturate Lead, protoporphyrin, fluorometric Thin layer chromatography, cocaine Digoxin control serum, RIA

GMDN Code

31575 31576 31577 31578 31579 31580 31581 31582 31583 31584 31585 31586 31587 31588 31589 31590 31591 31592 31593 31594 31595 31596 31597 31598 31599 31600 31601 31602 31603 31604 31605 31606 31607 31608 31609 31610 31611 31612 31613 31614

EDMA Code

12 08 02 07 12 08 03 04 12 50 01 02 12 09 01 01 11 02 01 33 12 09 01 03 12 09 01 01 12 09 01 90 12 09 01 10 12 09 01 90 12 08 02 02 00 00 00 00 12 08 01 01 12 50 01 01 12 50 01 02 12 09 01 05 12 08 02 90 11 02 01 90 12 09 01 03 12 08 02 07 12 08 01 02 12 09 01 10 12 09 01 13 12 08 03 90 12 09 01 03 12 09 01 01 12 09 01 07 11 03 01 90 12 08 02 02 12 09 02 07 11 01 01 11 12 50 01 01 12 09 01 06 12 08 02 90 12 08 02 07 12 09 01 10 12 09 01 03 12 09 02 90 12 09 01 06 12 50 01 02

EDMA Term

Phenobarbital Gentamicin TDM/Drug Controls Amphetamines Group Zinc Barbiturates Amphetamines Group Other drugs of abuse Methadone Other drugs of abuse Ethosuximide Not for IVD use Digoxin TDM/Drug Standards / Calibrators TDM/Drug Controls Cannabinoids Other Central Nervous System TDM Other Substrates Barbiturates Phenobarbital Digitoxin Methadone Opiates Other Antibiotics TDM Barbiturates Amphetamines Group Codeine Other Electrolytes Ethosuximide Ethanol (Alcohol) Cholinesterase TDM/Drug Standards / Calibrators Cocaine + Cocaine Metabolites Other Central Nervous System TDM Phenobarbital Methadone Barbiturates Other Toxicology Cocaine + Cocaine Metabolites TDM/Drug Controls

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 40 of 108

GMDN Term

GMDN Code

EDMA Code

12 08 02 09 11 01 01 90 12 09 02 13 12 09 01 12 12 70 09 90 12 08 01 02 11 03 01 90 12 08 02 02 12 09 01 06 12 09 01 01 12 09 01 12 12 08 01 01 12 50 01 02 12 08 02 02 12 08 01 01 12 08 01 01 12 09 01 10 12 08 01 02 12 09 02 90 11 03 01 90 12 09 01 01 11 03 01 90 12 08 01 01 11 01 01 11 12 09 02 07 12 09 01 12 12 09 01 09 12 09 01 06 12 08 02 07 21 04 10 01 12 08 02 09 21 01 10 01 12 08 02 90 12 08 01 01 12 08 02 90 12 09 02 90 12 09 01 12 12 09 01 15 12 08 01 01 12 09 01 10

EDMA Term

Primidone Other Enzymes Salicylate Morphines Other Drugs of Abuse/Toxicology Rapid Tests Digitoxin Other Electrolytes Ethosuximide Cocaine + Cocaine Metabolites Amphetamines Group Morphines Digoxin TDM/Drug Controls Ethosuximide Digoxin Digoxin Methadone Digitoxin Other Toxicology Other Electrolytes Amphetamines Group Other Electrolytes Digoxin Cholinesterase Ethanol (Alcohol) Morphines Lysergic acid diethylamide Cocaine + Cocaine Metabolites Phenobarbital GE Hardware + dedicated accessories + software Primidone CH Hardware + dedicated accessories + software Other Central Nervous System TDM Digoxin Other Central Nervous System TDM Other Toxicology Morphines Propoxyphene Digoxin Methadone

Gas chromatography, primidone 31615 Enzymatic method, alcohol dehydrogenase, ultraviolet 31616 Liquid chromatography, salicylate 31617 Gas chromatography, morphine 31618 Salicylate rapid test 31619 Radioimmunoassay, digitoxin (125-I), rabbit antibody, solid phase sep. 31620 Atomic absorption spectroscopy kit, antimony 31621 Liquid chromatography, ethosuximide 31622 31623 Free radical, benzoylecgnonine Liquid chromatography, amphetamine 31624 31625 Thin layer chromatography, morphine Radioimmunoassay, digoxin (125-I), rabbit antibody, second antibody 31626 Ethanol calibrator 31627 Thin layer chromatography, ethosuximide 31628 Radioimmunoassay, digoxin (3-H), rabbit antibody, coated tube sep. 31629 Radioimmunoassay, digoxin (125-I), rabbit antibody, double label 31630 Liquid chromatography, methadone 31631 Radioimmunoassay, digitoxin (3-H), rabbit antibody, charcoal sep. 31632 Lead, protoporphyrin zinc method, fluorometric 31633 Atomic absorption spectroscopy kit, arsenic 31634 Gas chromatography, amphetamine 31635 Atomic absorption spectroscopy kit, lead 31636 Radioimmunoassay, digoxin (125-I), rabbit antibody, polyethylene 31637 Electrometry, cholinesterase 31638 Potassium dichromate, alcohol 31639 Free radical assay, morphine 31640 Free radical assay, LSD 31641 Thin layer chromatography, benzoylecgnonine 31642 Liquid chromatography, phenobarbital 31643 31644 Analyser, mass spectrometry Thin layer chromatography, primidone 31645 Analyser, lead 31646 Liquid chromatography, diphenylhydantoin 31647 Radioimmunoassay, digoxin (125-I), rabbit antibody, charcoal sep. 31648 Thin layer chromatography, diphenylhydantoin 31649 Mercury kit 31650 Liquid chromatography, morphine 31651 Thin layer chromatography, propoxyphene 31652 Radioimmunoassay, digoxin (125-I), rabbit antibody, coated tube sep. 31653 Free radical assay, methadone 31654

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 41 of 108

GMDN Term

Liquid chromatography, primidone Densitometer Activated partial thromboplastin Fibrinogen control Control, plasma, abnormal Acid hematin Guaiac reagent White blood cell control Control, hemoglobin Plasma, coagulation control Test, prothrombin consumption Assay, erythropoietin Test, time, partial thromboplastin Tube, sedimentation rate Test, leukocyte alkaline phosphatase Fibrin split product Centrifuge, microsedimentation Test, sickle cell Haemocytometer Reagent, platelet aggregation Carboxyhaemoglobin kit Haematocrit kit Solution, gugol blue Fibrometer Diluent, blood cell Haemoglobinometer Glutathione, red-cell Plasma, fibrinogen control Haemoglobin S Test, fibrinogen Plasma, control, normal Test, thrombin time Thrombin Sulfhaemoglobin kit Romanowsky stain Control, platelet Red blood cell control Test, time, prothrombin Device, automated sedimentation rate Centrifuge, haematocrit

GMDN Code

31655 31737 32392 32393 32394 32395 32396 32397 32398 32399 32400 32401 32402 32403 32404 32405 32406 32407 32408 32409 32410 32411 32412 32413 32414 32415 32416 32417 32418 32419 32420 32421 32422 32423 32424 32425 32426 32427 32428 32429

EDMA Code

12 08 02 09 21 05 10 01 13 02 01 02 13 02 50 90 13 02 50 02 13 07 01 02 11 70 03 01 13 01 20 90 13 01 20 04 13 02 50 02 13 02 01 01 12 07 01 01 13 02 01 02 13 01 09 11 11 01 01 05 13 02 05 02 28 01 10 01 16 01 01 09 23 05 10 01 13 02 04 01 13 01 02 02 23 09 10 01 13 01 03 90 23 02 10 01 13 01 01 01 23 09 10 01 13 01 09 01 13 02 50 02 13 01 02 02 13 02 02 01 13 02 50 02 13 02 01 03 13 02 01 03 13 01 02 02 13 01 03 02 13 01 20 05 13 01 20 03 13 02 01 01 23 09 10 01 23 09 10 01

EDMA Term

Primidone EP Hardware + dedicated accessories + software Activated Partial Thromboplastin Time Other Haemostasis Controls Control Plasmas Cytochemical staining reagents Faecal Occult Blood (CC) IC =>12.03.90.04 Other Haematology Controls Haemoglobin Control Control Plasmas Prothrombin time ( Quick Test ) Erythropoietin Activated Partial Thromboplastin Time Erythrocyte Sedimentation Rate Test Alkaline Phosphatase - Total Fibrinogen Degradation Products SP Hardware + accessories + software Sickle Cell Anemia HC Hardware + dedicated accessories + software Aggregation Factors Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Other_HHC Hardware + dedicated accessories + software Other Haematology stains HS Hardware + dedicated accessories + software CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) Other_HHC Hardware + dedicated accessories + software Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Control Plasmas Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Fibrinogen Assays (Factor I) Control Plasmas Thrombin Time / Reptilase / Batroxobin Time Thrombin Time / Reptilase / Batroxobin Time Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Romanowsky stains Platelet Control Control Blood Multilevel Prothrombin time ( Quick Test ) Other_HHC Hardware + dedicated accessories + software Other_HHC Hardware + dedicated accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 42 of 108

GMDN Term

Cyanomethemoglobin kit Counter, cell, automated (particle counter) Instrument, coagulation, automated Test, thromboplastin generation System, haemoglobin, automated Aggregometer, platelet, thrombokinetogram Instrument, automated platelet counting Counter, differential cell Platelet counting, manual Haematocrit control Sporothrix schenekii kit Antigen, latex agglutination, Coccidioides immitis Coccidioides immitis control Antigen, Histoplasma capsulatum, all Histoplasma capsulatum control Nontreponemal control Nontreponemal kit Serum, reactive/non-specific control, FTA-ABS test Anti-human globulin, FTA-ABS test Antigen, HA, Treponema pallidum Test, sorbent, FTA-ABS Antisera, fluorescent antibody for FTA-ABS test Antigen, IHA, T. cruzi Antigen, latex agglutination, T. cruzi Antigen, CF, T. cruzi Antigen, HA, echovirus 1-34 Antiserum, CF, Epstein-Barr virus Antigen, HA including HA control, influenza virus C Antigen, CF including CF control, influenza virus C Antiserum, fluorescent, rabies virus Antiserum, fluorescent, C. diphtheriae Antigen, B. parapertussis Antigen, B. pertussis Antigen, latex agglutination, Trichinella spiralis Antigen, bentonite flocculation, Trichinella spiralis Antiserum, fluorescent, Q fever Antiserum, rickettsial pox Antiserum, murine typhus fever Antiserum, typhus fever Antigen, CF, typhus fever group

GMDN Code

32430 32431 32433 32434 32435 32436 32437 32438 32439 32440 32442 32443 32444 32445 32446 32449 32450 32451 32452 32453 32454 32455 32456 32457 32458 32459 32460 32461 32462 32463 32466 32467 32468 32469 32470 32471 32472 32473 32474 32475

EDMA Code

13 01 02 01 23 01 10 01 23 02 10 01 13 02 01 02 23 09 10 01 23 02 10 01 23 01 10 01 23 01 10 01 13 01 01 90 13 01 20 90 15 06 01 90 15 06 01 90 15 50 01 06 15 06 01 90 15 50 01 06 15 50 01 01 15 01 90 90 15 01 03 03 15 01 03 03 15 01 03 01 15 01 03 03 15 01 03 03 15 05 10 02 15 05 10 02 15 05 10 02 15 04 80 90 15 04 04 04 15 04 80 04 15 04 80 04 15 04 80 90 15 01 90 08 15 01 90 07 15 01 90 07 15 05 10 90 15 05 10 90 15 01 90 03 15 01 90 05 15 01 90 05 15 01 90 05 15 01 90 05

EDMA Term

Haemoglobin determinations (Total Hb) CC Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software Activated Partial Thromboplastin Time Other_HHC Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software Other Reagents for Haematology Analyzer Other Haematology Controls Other Mycology Immunoassays Other Mycology Immunoassays Mycology Controls - Inf.Imm. Other Mycology Immunoassays Mycology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Other Other Bacteriology Immunoassays Syphilis Antibody Assays Total Syphilis Antibody Assays Total Syphilis Antigen Detection Syphilis Antibody Assays Total Syphilis Antibody Assays Total Chagas Chagas Chagas Other Viral Antigen/Antibody Detection EBV Antibodies Influenza & Para Influenza Influenza & Para Influenza Other Viral Antigen/Antibody Detection Diphteria (Corynebacterium D.) Bordetella pertussis / parapertussis Bordetella pertussis / parapertussis Other Parasitology Other Parasitology Coxiella Rickettsia Rickettsia Rickettsia Rickettsia

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 43 of 108

GMDN Term

Antiserum, rocky mountain spotted fever Antigen, CF, spotted fever group Antiserum, CF, Q fever Antigen, CF, Q fever Antiserum, CF, psittacosis (Chlamydia group) Rhinovirus kit Cytomegalovirus antigen control Antiserum, CF, cytomegalovirus Antiserum, CF, lymphocytic choriomeningitis virus Antigen, CF, lymphocytic choriomeningitis virus Parainfluenza virus kit Antiserum, fluorescent, mumps virus Antiserum, CF, mumps virus Antiserum, HAI, mumps virus Antiserum, fluorescent, rubeola Antiserum, CF, rubeola Antiserum, HAI, rubeola Antigen, all groups, salmonella spp Antiserum, fluorescent, Mycobacterium tuberculosis Antiserum, fluorescent, Erysipelothrix rhusiopathiae Antiserum, Erysipelothrix rhusiopathiae Antigen, Erysipelothrix rhusiopathiae Antiserum, fluorescent, Francisella tularensis Antiserum, Francisella tularensis Febrile antigen control Vibrio cholerae kit Antiserum, Pseudomonas pseudomallei Flavobacterium meningosepticum kit Acinetobacter calcoaceticus kit Serratia marcesans kit Arizona kit Citrobacter kit Anti-streptokinase Antigen, all group, Streptococcus spp. Solution, Fontanna silver Giemsa stain Glenner's stain Gold chloride Hematoxylin Iron chloride-weigert

GMDN Code

32476 32477 32478 32479 32480 32481 32483 32484 32485 32486 32487 32488 32489 32490 32491 32492 32493 32495 32496 32497 32498 32499 32500 32501 32502 32504 32505 32506 32507 32508 32509 32510 32513 32514 32887 32888 32889 32890 32891 32892

EDMA Code

15 01 90 05 15 01 90 05 15 01 90 03 15 01 90 03 15 01 01 90 15 04 80 90 15 50 01 04 15 04 02 04 15 04 80 13 15 04 80 13 15 04 80 04 15 04 80 08 15 04 80 08 15 04 80 08 15 04 01 04 15 04 01 04 15 04 01 04 15 01 10 01 15 01 07 03 15 01 90 90 15 01 90 90 15 01 90 90 15 01 90 90 15 01 90 90 15 50 01 01 15 01 90 90 15 01 90 13 15 01 90 90 14 02 03 01 15 01 90 90 14 02 03 01 14 90 90 90 12 11 01 03 15 01 11 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01

EDMA Term

Rickettsia Rickettsia Coxiella Coxiella Other Chlamydia Reagents Other Viral Antigen/Antibody Detection Other Virology Controls - Inf.Imm. CMV Antibodies - Total LCM Virus LCM Virus Influenza & Para Influenza Mumps / Parotitis Mumps / Parotitis Mumps / Parotitis Rubella Virus Antibodies - Total Rubella Virus Antibodies - Total Rubella Virus Antibodies - Total Salmonella Antigen Detection Mycobacterial Antibody Assays Other Other Bacteriology Immunoassays Other Other Bacteriology Immunoassays Other Other Bacteriology Immunoassays Other Other Bacteriology Immunoassays Other Other Bacteriology Immunoassays Bacteriology Controls - Inf.Imm. Other Other Bacteriology Immunoassays Pseudomonas Other Other Bacteriology Immunoassays Serotyping (E.coli, Salmonella, Shigella, etc.) Other Other Bacteriology Immunoassays Serotyping (E.coli, Salmonella, Shigella, etc.) Other Other Microbiology Tests Anti-Streptokinase (ASK) Streptococcal Direct Antigen Detection Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 44 of 108

GMDN Term

Leuco-patent blue Light green Luxol fast blue Metanil yellow Methyl green Mucicarmine Muller's colloidal iron Nile blue Nuclear fast red Oil red O Orange G Phloxine B Hematoxylin, acid, phosphotungstic Picro methyl blue Pyronin Red-violet LB Resorcin fuchsin Safranin Sirius red Sudan black B Titan yellow Toluidine blue Van Gieson's picro-fuchsin Heparin Streptolysin O Diastase Hyaluronidase Trypsin Hematoxylin, chrome alum Best's carmine Bath, flotation, tissue Cytocentrifuge Solution, decalcifier, electrolytic Formalin, neutral buffered Gelatin-formalin Solution, formalin-sodium acetate Formalin-saline Solution, formol calcium Solution, formalin ammonium bromide Solution, formalin-alcohol-acetic acid

GMDN Code

32893 32894 32895 32896 32897 32898 32899 32900 32901 32902 32903 32904 32905 32906 32907 32908 32909 32910 32911 32912 32913 32914 32915 32918 32919 32920 32921 32922 32924 32925 32931 32933 32934 32938 32941 32942 32943 32944 32945 32946

EDMA Code

13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 02 03 05 12 11 01 05 11 01 01 07 12 11 01 02 11 01 01 30 14 01 08 02 14 01 08 02 00 00 00 00 28 01 10 01 13 02 80 90 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00

EDMA Term

Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Heparin Anti-Streptolysin/Anti-Streptolysin O (qualitative) Amylase - Total Anti-Streptococcal Hyaluronidase Trypsin (CC) IC =>12.01.90.07 Other Stains Other Stains Not for IVD use SP Hardware + accessories + software Other Auxiliary Reagents (Haemostasis) Not for IVD use Not for IVD use Not for IVD use Not for IVD use Not for IVD use Not for IVD use Not for IVD use

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 45 of 108

GMDN Term

GMDN Code

33154 33155 33156 33157 33158 33159 33160 33163 33164 33165 33166 33195 33196 33197 33214 33215 33216 33217 33218 33219 33220 33221 33222 33223 33224 33225 33226 33227 33228 33229 33230 33231 33232 33233 33234 33235 33236 33237 33238 33239

EDMA Code

13 02 03 03 13 02 01 04 13 02 06 02 00 00 00 00 23 02 10 01 23 02 10 01 00 00 00 00 13 01 01 01 11 01 01 02 11 01 01 05 13 02 03 90 23 09 10 01 00 00 00 00 00 00 00 00 11 01 01 07 11 04 02 01 11 02 01 03 11 03 01 03 11 03 01 03 11 04 01 02 12 01 03 02 11 03 01 04 12 06 02 04 11 02 01 07 11 02 01 01 11 02 01 01 11 03 01 07 11 03 01 07 11 03 01 09 11 02 01 30 11 02 01 30 11 04 01 07 11 03 01 10 11 02 01 31 11 02 01 31 11 02 01 31 11 02 01 04 12 06 05 03 12 06 05 03 11 02 01 34

EDMA Term

Fibrin sensitivity monomer Activated Clotting Time Antithrombin III Not for IVD use HS Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software Not for IVD use CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) Acid Phosphatase (CC) IC => 12.03.01.37 Alkaline Phosphatase - Total Other Special Coagulation Tests Other_HHC Hardware + dedicated accessories + software Not for IVD use Not for IVD use Amylase - Total Carbon Dioxide - Electrodes Bilirubin Calcium Calcium Calcium - Electrodes Ceruloplasmin Chloride Cortisol Creatinine Albumin (CC) IC =>12.01.03.01 Albumin (CC) IC =>12.01.03.01 Magnesium Magnesium Potassium Total Protein Total Protein Sodium - Electrodes Sodium Triglycerides Triglycerides Triglycerides Urea/Blood Urea Nitrogen 17-Hydroxy-Ketosterone 17-Hydroxy-Ketosterone Lipoprotein Electrophoresis

Fibrin monomer paracoagulation Activated whole blood clotting time kit Antithrombin III quantitation Timer, general laboratory Aggregrometer, platelet Aggregometer, platelet, photo-optical scanning Study, platelet adhesive Fluid, diluting, manual cell Acid phosphatase, cytochemical Alkaline phosphatase kit Bothrops atrox reagent Analyzer, oxyhemoglobin concentration, blood-phase, indwelling Analyser, gas, neon Analyser, gas, argon Catalytic methods, amylase pH rate measurement, carbon-dioxide Enzymatic method, bilirubin Atomic absorption spectroscopy kit, calcium Fluorometric, calcium Electrode, ion specific, calcium Indirect copper assay, ceruloplasmin Coulometric, chloride Fluorometric, cortisol Enzymatic method, creatinine Nephelometric method, globulin Turbidimetric method, globulin Atomic absorption spectroscopy kit, magnesium Photometric method, magnesium Flame photometry, potassium Turbidimetric, total protein Refractometric, total protein Electrode, ion specific, sodium Flame photometry, sodium Fluorometric method, triglycerides Turbidimetric method, triglyceride Colorimetric method, triglyceride O-phthalaldehyde, urea nitrogen Fluorometric method, 17-hydroxycorticosteroid Radioassay, 17-hydroxycorticosteroid Electrophoretic method, lecithin/sphingomyelin ratio

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 46 of 108

GMDN Term

GMDN Code

33240 33241 33242 33243 33244 33245 33246 33247 33248 33249 33250 33251 33252 33253 33254 33255 33256 33257 33258 33259 33260 33261 33262 33263 33264 33265 33266 33267 33268 33269 33270 33271 33272 33273 33274 33275 33276 33277 33278 33279

EDMA Code

11 02 01 34 11 02 01 20 11 02 01 34 12 01 04 21 11 02 01 20 11 01 01 15 11 02 01 12 11 02 01 12 11 03 01 01 11 03 01 01 11 03 01 01 11 03 01 06 12 04 01 90 12 04 01 90 11 70 02 01 11 70 02 01 11 70 02 01 11 70 02 01 11 70 02 01 11 50 03 02 11 50 03 02 11 50 03 02 11 50 03 01 11 02 01 16 28 01 10 01 21 01 10 01 00 00 00 00 21 05 10 01 11 70 02 01 11 01 01 90 11 02 01 29 11 02 01 09 12 01 01 20 00 00 00 00 12 06 03 02 23 09 10 01 11 01 01 12 11 01 01 12 11 02 01 06 11 02 01 06

EDMA Term

Lipoprotein Electrophoresis Lipoprotein, Chemical determination/detection Lipoprotein Electrophoresis Lipoprotein ( a ) Lipoprotein, Chemical determination/detection Creatine Kinase Isoenzymes Galactose Galactose Ammonia Ammonia Ammonia Lithium Other thyroid hormones Other thyroid hormones Urine Single Test Strips (incl. tablets) Urine Single Test Strips (incl. tablets) Urine Single Test Strips (incl. tablets) Urine Single Test Strips (incl. tablets) Urine Single Test Strips (incl. tablets) Calibrators Single Component (CC) Calibrators Single Component (CC) Calibrators Single Component (CC) Calibrators Multicomponent (CC) Iron (CC) IC =>12.07.01.04 SP Hardware + accessories + software CH Hardware + dedicated accessories + software Not for IVD use EP Hardware + dedicated accessories + software Urine Single Test Strips (incl. tablets) Other Enzymes Total Porphyrine Delta-Aminolaevulinic acid Kappa and Lambda chain Not for IVD use Calcitonin Other_HHC Hardware + dedicated accessories + software Chymotrypsin Chymotrypsin Copper Copper

Microdensitometry method, lipoproteins Turbidimetric method, lipoproteins Electrophoretic separation, lipoproteins Radial immunodiffusion, lipoproteins Nephelometric method, lipoprotein Chromatographic separation, CPK isoenzymes Enzymatic method, galactose Colorimetric method, galactose Photometric method, ammonia Method, ion-exchange, ammonia Enzymatic method, ammonia Atomic absorption spectroscopy kit, lithium Wet ash method, protein-bound iodine Iodine kit Enzymatic method, glucose, urinary, non-quantitative Metallic reduction method, glucose, urinary non-quantitative Ketone kit Urine occult blood kit Blood, occult, enzymatic method, in urine Calibrator, primary Calibrator, secondary Calibrator, surrogate Calibrator, multi-analyte mixture Atomic absorption spectroscopy kit, iron Clinical sample concentrator Enzyme analyser, clinical use Osmometer for clinical use Apparatus, electrophoresis, for clinical use Dinitrophenyl hydrazone kit Isocitric dehydrogenase kit Fluorometric measurement, porphyrin Acid, delta-aminolevulinic, ion-exchange columns with colorimetry Bence-Jones protein kit Chromium-51 solution Radioimmunoassay, calcitonin Analyser, oxyhaemoglobin N-acetyl-l-tyrosine ethyl ester (U.V.), chymotrypsin N-benzoyl-l-tyrosine ethyl ester (U.V.), chymotrypsin Oxalydihydrazide (spectroscopic), copper Diethyldithiocarbamate (colorimetric), copper

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 47 of 108

GMDN Term

Conversion to creatinine, creatine Cystine kit Radioimmunoassay, desoxycorticosterone Titrimetric, fatty acids Chromatographic, glutathione Enzymatic glutathione kit Spectrophotometric method, pregnanetriol Pregnanetriol kit Radioummunoassay, progesterone Acid, pyruvic, enzymatic (U.V.) Radioimmunoassay, thyroid-stimulating hormone Radioimmunoassay, 17-hydroxyprogesterone Ascorbic acid kit Oestrogen kit Radioimmunoassay, glucagon Radioimmunoassay, human placental lactogen Histidine kit Microbiological, histidine Alpha-ketobutyric acid kit Malic acid kit Nitrite kit Pregnenolone kit Beta-D-fructose/NADH oxidation UV, sorbitol Immunochemical, thyroglobulin autoantibody Immunochemical, transferrin Chromatographic, phospholipids Fluorometric, uroporphyrin Trifluoroacetic acid, vitamin A, hexane extraction Colorimetric, xylose Analyser, heparin System, automated platelet aggregation Haemoglobin M Haemoglobin F quantitation Haemoglobin A2 quantitation Antithrombin III, two stage clotting time assay Test, erythrocyte sedimentation rate Analyser, haematology, haematocrit Colorimetric method, gamma-glutamyl transpeptidase Kinetic method, gamma-glutamyl transpeptidase Centrifuges (micro, ultra, refrigerated) for clinical use

GMDN Code

33280 33281 33282 33283 33284 33285 33286 33287 33288 33289 33290 33291 33292 33293 33294 33295 33296 33297 33298 33299 33300 33301 33302 33303 33304 33305 33306 33307 33308 33321 33322 33323 33324 33325 33326 33327 33328 33330 33331 33332

EDMA Code

11 02 01 07 12 06 90 90 12 05 01 14 11 02 01 22 13 01 09 01 13 01 09 01 12 05 01 07 12 05 01 07 12 05 01 06 11 02 01 26 12 04 01 11 12 05 01 07 11 02 01 90 12 05 02 04 12 06 01 02 12 05 02 07 12 06 90 90 12 06 90 90 11 01 01 18 11 01 01 25 11 70 02 01 12 05 02 90 11 01 01 29 12 10 03 04 12 01 03 08 11 02 01 24 11 02 01 90 12 07 02 90 11 02 01 08 23 02 10 01 23 02 10 01 13 01 02 02 13 01 02 02 13 01 02 02 13 02 06 02 13 01 09 11 23 01 10 01 11 01 01 16 11 01 01 16 28 01 10 01

EDMA Term

Creatinine Other Individual and Specified Hormones 11-Desoxycortisol Non Esterified Fatty Acids Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) 17 OH Progesterone 17 OH Progesterone Progesterone Pyruvate Thyroid Stimulating Hormone 17 OH Progesterone Other Substrates Estrone Glucagon Human Placental Lactogen Other Individual and Specified Hormones Other Individual and Specified Hormones Hydroxybutyrate Dehydrogenase Malate Dehydrogenase Urine Single Test Strips (incl. tablets) Other Pregnancy Testing Hormones Sorbitol Dehydrogenase Thyroglobulin Autoantibodies Transferrin Phospholipids Other Substrates Other Vitamin Tests D-Xylose HS Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Antithrombin III Erythrocyte Sedimentation Rate Test CC Hardware + dedicated accessories + software Gamma Glutamyltransferase Gamma Glutamyltransferase SP Hardware + accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 48 of 108

GMDN Term

GMDN Code

33333 33334 33335 33336 33337 33338 33339 33341 33342 33345 33346 33347 33348 33349 33350 33351 33352 33353 33354 33355 33356 33357 33358 33359 33360 33361 33362 33363 33364 33365 33366 33367 33368 33372 33373 33375 33376 33377 33378 33379

EDMA Code

11 02 01 17 12 07 01 05 11 02 01 04 11 02 01 90 11 02 01 08 11 02 01 90 00 00 00 00 21 02 10 01 00 00 00 00 14 90 90 90 14 02 05 01 14 90 90 90 14 01 02 01 14 02 02 90 14 01 03 01 14 01 14 01 14 01 14 01 01 04 24 09 30 01 14 02 05 01 14 02 02 05 14 03 04 02 14 02 02 01 14 02 02 90 14 02 02 02 15 01 07 01 15 01 90 13 24 01 30 01 14 01 08 90 14 01 08 14 02 02 06 14 02 05 01 15 50 01 06 15 01 03 01 23 09 10 01 12 12 01 90 15 06 01 90 15 01 12 01 15 05 10 90

EDMA Term

Iron Binding Capacity - Total (CC) IC =>12.07.01.05 Iron Binding Capacity - Total (IC) CC =>11.02.01.17 Urea/Blood Urea Nitrogen Other Substrates D-Xylose Other Substrates Not for IVD use IC Hardware + dedicated accessories + software Not for IVD use Other Other Microbiology Tests MIC Systems - Manual Other Other Microbiology Tests Broth Media (Tubes) Other Manual Identification (Optichin, Bacitracin etc.) Agar Media for Pouring (Bottles) Bacteriology - Culture Bacteriology - Culture Bacteriology - Culture Additives for DCM Other_MCB Consumables MIC Systems - Manual Anaerobes - Manual Identification Systems for Fungi - Manual Enterobacteriaceae - Manual Other Manual Identification (Optichin, Bacitracin etc.) Non-fermenters - Manual Mycobacterial Antigen Detection Pseudomonas SI Consumables Miscellaneous Buffers, Controls and Standards Stains, Buffers etc (Bacteriology) Haemophilus & Neisseria - Manual MIC Systems - Manual Mycology Controls - Inf.Imm. Syphilis Antigen Detection Other_HHC Hardware + dedicated accessories + software Other Liver Function Other Mycology Immunoassays Staphylococcal Direct Antigen Detection Other Parasitology

Bathophenanthroline, iron binding capacity Radiometric, FE59, iron binding capacity Nitrogen kit Uroporphyrin kit P-bromoaniline, xylose Mucopolysaccharide kit Balance, analytical Nephelometer, for clinical use pH meter Culture medium, amino acid assay Culture medium, antibiotic assay Culture medium, vitamin assay Culture medium general nutrient broth Culture media, single biochemical test Culture medium, non-selective/non-differential Culture medium, non-selective/differential Culture medium, selective/differential Culture medium, selective/non-differential Culture medium supplement Culture medium, transport, anaerobic Culture media, antimicrobial susceptibility test, excluding Mueller Kit, anaerobic identification Dermatophyte kit Enterobacteriaceae kit Fastidious organism kit Glucose nonfermenter kit Kit, identification, Mycobacteria Kit, identification, Pseudomonas Disc, strips and reagent, microorganism differentiation Culture medium control Stain, microbiologic Culture medium, Neisseria isolation, pathogenic Culture medium, antimicrobial susceptibility test Cryptococcus neoformans control Antigen, Treponema pallidum for FTA-ABS test Blood volume measuring Adenosine triphosphate kit Antigen, CF, B. dermatitidis Kit, screening, Staphylococcus aureus Trichomonas kit

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 49 of 108

GMDN Term

Kit, screening, urine Kit, identification, yeast Kit, screening, yeast Enzyme immunoassay, propoxyphene Enzyme immunoassay, cocaine Atomic absorption spectrophotometer, general use System, test, beta-2-microglobulin immunological Properdin factor B control Prealbumin, antigen, antiserum, control Electrophoresis instrumentation Fluorometer Nephelometer Solution, decalcifier, acid containing Chelating agent, decalcification Fixative, osmium tetroxide Fixative, paraformaldehyde Mounting medium, oil soluble Mounting medium, water soluble Neutral red Assay, heparin Blastomyces dermatitidis control Strip, virulence, Corynebacterium diphtheriae Adenine nucleotide kit Nephelometric, amylase Fluorometer, for clinical use Acid, lactic, enzymatic method Radioassay, triiodothyronine uptake Enzymatic, carbon-dioxide Fraction V, antigen, antiserum, control Cell, animal/human, cultured Kit, Mycoplasma detection Culture medium, Mycoplasma detection Radioimmunoassay, kanamycin Indigocarmine Janus green B Malachite green Martius yellow Methyl orange Methyl violet 2B Methylene violet

GMDN Code

33380 33381 33382 33387 33388 33389 33418 33419 33420 33422 33423 33424 33486 33487 33488 33489 33494 33495 33496 33497 33498 33499 33524 33527 33528 33529 33530 33532 33533 33543 33544 33545 33546 33548 33549 33550 33551 33552 33553 33554

EDMA Code

14 01 07 02 14 03 04 01 14 03 04 01 12 09 01 15 12 09 01 06 21 04 10 01 12 03 90 02 12 01 02 90 12 01 03 06 21 05 10 01 21 02 10 01 21 02 10 01 13 02 80 90 13 02 80 90 13 07 01 05 13 07 01 05 13 07 01 06 13 07 01 06 14 01 08 02 13 02 03 05 15 50 01 06 15 01 90 08 13 01 90 90 11 01 01 07 21 02 10 01 11 02 01 18 12 04 01 06 11 03 01 02 12 01 01 90 14 04 01 01 15 01 08 01 14 02 02 07 12 08 03 05 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01

EDMA Term

Urine Screening Manual (Strips etc.) Identification Systems for Yeasts - Manual Identification Systems for Yeasts - Manual Propoxyphene Cocaine + Cocaine Metabolites GE Hardware + dedicated accessories + software Beta2-Microglobulin Other Complement Components Pre-albumin / Transthyretin EP Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software Other Auxiliary Reagents (Haemostasis) Other Auxiliary Reagents (Haemostasis) Fixing reagents (Histology/Cytology) Fixing reagents (Histology/Cytology) Mounting media (Histology/Cytology) Mounting media (Histology/Cytology) Other Stains Heparin Mycology Controls - Inf.Imm. Diphteria (Corynebacterium D.) Other Other Haematology Reagents Amylase - Total IC Hardware + dedicated accessories + software Lactate T- Uptake Bicarbonate Other Immunoglobulins Cells for Tissue Culture Mycoplasma Antigen Detection Mycoplasma - Manual Kanamycin Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 50 of 108

GMDN Term

Nigrosin Orange II Orcein Protargol S Rose bengal Sudan III Sudan IV Thionin Methylene blue thiocyanate Periodic acid kit Radioimmunoassay, tobramycin Enzyme immunoassay, non-radiolabeled, total thyroxine Radioimmunoassay, cocaine metabolite Enzymatic radiochemical assay, gentamicin Amikacin serum assay Radioimmunoassay, amikacin Enzyme immunoassay, lidocaine Enzyme immunoassay, theophylline Enzyme immunoassay, carbamazepine Phenolphthalein colorimetry, carbon-dioxide Slide stainer, automated Stain, hematology Glucose-6-phosphate dehydrogenase kit Assay, glutathione reductase Instrument, coagulation Assay, foetal haemoglobin System, fibrinogen determination Radioassay, angiotensin converting enzyme Automated urinalysis system Galactose-1-phosphate kit Copper sulfate solution Centrifuge, blood-bank for in vitro diagnostic use Boxes, view, blood grouping Carbonic anhydrase kit Anti-DNA indirect immunofluorescent solid phase C3-indirect immunofluorescent solid phase System, test, infectious mononucleosis Reagent, immunoassay, IgG Complement C3b activator immunoassay reagent Radioimmunoassay, cholyglycine, bile acid

GMDN Code

33555 33556 33557 33558 33559 33560 33561 33562 33563 33564 33566 33569 33570 33571 33572 33573 33574 33575 33576 33590 33617 33637 33638 33639 33640 33641 33642 33645 33646 33647 33671 33672 33673 33683 33684 33685 33686 33687 33688 33713

EDMA Code

13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 12 08 03 09 12 04 01 07 12 09 01 06 12 08 03 04 12 08 03 01 12 08 03 01 12 08 01 05 12 08 04 02 12 08 02 01 11 03 01 02 23 05 10 01 13 01 03 90 13 01 09 01 13 01 09 01 23 02 10 01 13 01 02 02 13 02 02 01 12 06 02 03 21 01 10 01 14 02 05 90 13 01 09 90 28 01 10 01 23 03 10 01 12 01 90 90 12 10 01 05 12 01 02 03 15 04 04 11 12 01 01 05 12 01 02 03 11 02 01 02

EDMA Term

Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Tobramycin Thyroxine Cocaine + Cocaine Metabolites Gentamicin Amikacin Amikacin Lidocaine Theophylline Carbamazepine Bicarbonate HC Hardware + dedicated accessories + software Other Haematology stains Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) HS Hardware + dedicated accessories + software Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Fibrinogen Assays (Factor I) Angiotensin Converting Enzyme (IC) CC =>11.01.01.09 CH Hardware + dedicated accessories + software Other Manual Susceptibility Testing Other Other Haematology Testing Reagents SP Hardware + accessories + software BG Hardware + dedicated accessories + software Other Other Plasma Proteins ds DNA - Antibodies Complement Component C3/C3c Mononucleosis Inf. Imm.=> 15 70 90 03 Immunoglobulin G Complement Component C3/C3c Bile acids

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 51 of 108

GMDN Term

GMDN Code

33730 33731 33755 33756 33759 33762 33763 33764 33765 33766 33767 33768 33769 33770 33771 33772 33773 33774 33775 33776 33777 33778 33779 33780 33781 33782 33783 33784 33798 33801 33802 33803 33805 33807 33809 33810 33811 33813 33814 33815

EDMA Code

12 09 01 11 12 08 01 01 24 09 10 01 24 09 10 01 14 01 03 04 12 09 01 03 12 09 01 04 12 09 01 04 12 09 01 04 12 09 01 07 12 09 01 07 12 09 01 02 12 09 01 02 12 09 01 13 12 09 01 13 12 09 01 15 12 09 01 15 12 08 01 09 12 08 01 06 12 08 05 01 12 08 05 01 12 08 05 01 12 08 01 07 12 50 01 02 12 50 01 02 12 50 01 02 12 50 01 02 12 50 01 02 11 02 01 34 12 08 03 07 12 08 01 09 12 08 04 02 12 08 03 04 00 00 00 00 12 09 01 14 12 09 01 14 12 09 01 14 13 02 04 02 12 08 03 04 12 08 03 09

EDMA Term

Methaqualone Digoxin Other_MCB Hardware + dedicated accessories + software Other_MCB Hardware + dedicated accessories + software Enrichment media (Bottles) Barbiturates Benzodiazepines Benzodiazepines Benzodiazepines Codeine Codeine Amphetamine/Methamphetamine Specific (+Ecstasy) Amphetamine/Methamphetamine Specific (+Ecstasy) Opiates Opiates Propoxyphene Propoxyphene Quinidine N-Acetylprocainamide Methotrexate Methotrexate Methotrexate Procainamide TDM/Drug Controls TDM/Drug Controls TDM/Drug Controls TDM/Drug Controls TDM/Drug Controls Lipoprotein Electrophoresis Sisomycin Quinidine Theophylline Gentamicin Not for IVD use Phencyclidine Phencyclidine Phencyclidine Platelet Factor 4 Gentamicin Tobramycin

Radioimmunoassay, methaqualone Enzyme immunoassay, digoxin Automated colony counter Manual colony counter Culture media, enriched High pressure liquid chromatography, barbiturate Gas chromatography, benzodiazipine High pressure liquid chromatography, benzodiazipine Thin layer chromatography, benzodiazipine Gas chromatography, codeine High pressure liquid chromatography, codeine Gas chromatography, methamphetamine Methamphetamine kit High pressure liquid chromatography, opiates Thin layer chromatography, opiates Gas chromatography, propoxyphene High pressure liquid chromatography, propoxyphene Quinine kit Enzyme immunoassay, N-acetylprocainamide Enzyme immunoassay, methotrexate Radioassay, methotrexate, enzyme Radioimmunoassay, methotrexate Enzyme immunoassay, procainamide Theophylline control material Lidocaine control material Methotrexate control material N-acetylprocainamide control material Procainamide control Electrophoresis, cholesterol via esterase-oxidase, HDL Radioimmunoassay, sisomicin Enzyme immunoassay, quinidine Radioimmunoassay, theophylline Enzyme immunoassay, gentamicin Tonometer (calibration and Q.C. of blood-gas instrument), clinical Thin layer chromatography, phencyclidine Radioimmunoassay, phencyclidine Enzyme immunoassay, phencyclidine Platelet factor 4 immunoassay Fluorescent immunoassay gentamicin Fluorescent immunoassay, tobramycin

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 52 of 108

GMDN Term

Radioimmunoassay, digoxin (125-I) Radioimmunoassay, digoxin (3-H) Radioimmunoassay, digitoxin (125-I) Human chorionic gonadotropin self-test kit Enzyme immunoassay, cannabinoid Instrumentation, high pressure liquid chromatography Enzymatic radiochemical assay, amikacin Enzymatic radiochemical assay, tobramycin Fixative, acid Fixative, metallic Fixative, formalin Fixative, alcohol Mounting media Stain, chemical solution Stain, dye solution Stain, dye powder Enzyme immunoassay, valproic acid Radioimmunoassay, vancomycin Fluorescent immunoassay, theophylline Fluorescent immunoassay, diphenylhydantoin Fluorescent immunoassay, phenobarbital Thin layer chromatography, theophylline Radioimmunoassay, tricyclic antidepressant drugs Enzyme immunoassay, digitoxin Nephelometric inhibition immunoassay, phenobarbital Conductivity rate, urea nitrogen Glucose dehydrogenase, glucose Fluorescent immunoassay, primidone Enzyme linked immunoabsorbent assay, rubella Enzyme linked immunoabsorbent assay, varicella-zoster Enzyme linked immunoabsorbent assay, cytomegalovirus Fluorescence polarization immunoassay, carbamazepine Assay, alpha-2-antiplasmin Trypan blue Device, fertility diagnostic Staphylococcus aureus protein A insoluble Antigen, ID, Candida albicans Staphylococcus aureus somatic antigen T lymphocyte surface marker kit Enzyme linked immunoabsorbent assay, rubeola

GMDN Code

33816 33817 33818 33819 33825 33826 33827 33828 33831 33832 33833 33834 33835 33836 33837 33838 33839 33840 33844 33845 33846 33847 33852 33855 33856 33857 33858 33859 33860 33861 33862 33865 33869 33871 33876 33879 33880 33887 33895 33896

EDMA Code

12 08 01 01 12 08 01 01 12 08 01 02 12 70 05 02 12 09 01 05 21 05 10 02 12 08 03 01 12 08 03 09 13 07 01 05 13 07 01 05 13 07 01 05 13 07 01 05 13 07 01 06 13 07 01 08 13 07 01 08 13 07 01 07 12 08 02 10 12 08 03 10 12 08 04 02 12 08 02 90 12 08 02 07 12 08 04 02 12 09 02 15 12 08 01 02 12 08 02 07 11 04 03 05 11 02 01 13 12 08 02 09 15 04 01 04 15 04 80 10 15 04 02 04 12 08 02 01 13 02 05 01 14 01 08 02 21 02 30 01 15 01 12 01 15 06 01 02 15 01 12 01 13 05 01 01 15 04 01 04

EDMA Term

Digoxin Digoxin Digitoxin HCG - Rapid Test Cannabinoids HPLC Hardware + dedicated accessories + software Amikacin Tobramycin Fixing reagents (Histology/Cytology) Fixing reagents (Histology/Cytology) Fixing reagents (Histology/Cytology) Fixing reagents (Histology/Cytology) Mounting media (Histology/Cytology) Stain solutions (Histology/Cytology) Stain solutions (Histology/Cytology) Stain powders (Histology/Cytology) Valproic Acid Vancomycin Theophylline Other Central Nervous System TDM Phenobarbital Theophylline Tricyclic Antidepressants (Total) Digitoxin Phenobarbital Urea - Electrodes Glucose Primidone Rubella Virus Antibodies - Total Varicella Zoster CMV Antibodies - Total Carbamazepine a2-Antiplasmin Other Stains IC Consumables Staphylococcal Direct Antigen Detection Candida albicans Staphylococcal Direct Antigen Detection Antibodies for B and T-cell subtyping Rubella Virus Antibodies - Total

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 53 of 108

GMDN Term

B lymphocyte marker kit Electrode, in vivo calcium ion selective Epstein-Barr virus immunoglobulin M kit Antigen, IHA, cytomegalovirus Antiserum, fluorescent, Chlamydia trachomatis Test, urine leukocyte Enzyme linked immunoabsorbent assay, mumps virus Enzyme linked immunoabsorbent assay, Mycoplasma spp. Antigen, indirect haemagglutination, Herpes spp. Antinuclear antibody, antigen, control Alpha1-acid glycoprotein control Analyser, urine, particle counting Anti-ribonucleoprotein antibody kit Anti-SM antibody, antigen and control Antibody IgM, IF, cytomegalovirus virus Respiratory syncytial virus, antigen, antibody, IFA Direct agglutination test, Toxoplasma gondii Kit, IgG, platelet associated Reagent, Clostridium difficile toxin Extractable antinuclear antibody, antigen and control Analyser, chromosome System, test, oxalate DNA-reagent, Mycobacterium spp. DNA-reagent, Mycoplasma spp. DNA-reagent, Legionella Latex agglutination assay, rubella Campylobacter Spp. pH meter for dialysis hydrogen ion concentration Neisseria control Epstein-barr virus, other DNA-reagent, Epstein-Barr virus Candida species, antibody detection Antigen, Blastomyces dermatitidis, other Antiserum, Blastomyces dermatitidis, other DNA-reagent, Neisseria DNA-reagent, Shigella spp. DNA-reagent, cytomegalovirus Reagent, rickettsia serological Cytokeratin Pneumocystis carinii

GMDN Code

33897 33901 33902 33903 33904 33907 33908 33909 33910 33913 33914 33915 33916 33917 33918 33919 33921 33925 33926 33928 33936 33940 33943 33944 33945 33947 33948 33955 33970 33971 33972 33973 33974 33975 33977 33978 33979 33980 34007 34008

EDMA Code

13 05 01 01 11 04 01 02 15 04 04 04 15 04 02 01 15 01 01 03 11 70 02 01 15 04 80 08 15 01 08 03 15 04 03 01 12 10 01 01 12 01 90 01 21 01 10 01 12 10 02 11 12 10 01 11 15 04 02 06 15 04 80 05 15 05 01 04 12 01 01 05 15 01 90 02 12 10 01 02 23 03 10 01 11 02 01 23 15 01 07 40 15 01 08 40 15 01 05 40 15 04 01 04 15 01 14 01 00 00 00 00 15 50 01 01 15 04 04 90 15 04 04 40 15 06 01 02 15 06 01 90 15 06 01 90 15 01 40 11 15 01 40 14 15 04 02 40 15 01 90 05 12 03 01 20 14 05 02 01

EDMA Term

Antibodies for B and T-cell subtyping Calcium - Electrodes EBV Antibodies CMV Antigen Chlamydia Antibody Assays Total Urine Single Test Strips (incl. tablets) Mumps / Parotitis Mycoplasma Antibody Assays HSV Antigen ANA Screening a1-Acid Glycoprotein ( Orosomucoid ) CH Hardware + dedicated accessories + software Anti-Ri Antibody Sm CMV IgM Respiratory Syncytial Virus (RSV) Toxoplasma Antibody (Total) Immunoglobulin G Clostridium difficile ENA Screening BG Hardware + dedicated accessories + software Oxalate Mycobacterial Detection by NA Reagents Mycoplasma Detection by NA Reagents Legionella Detection by NA Reagents Rubella Virus Antibodies - Total Campylobacter Direct Antigen Detection Not for IVD use Bacteriology Controls - Inf.Imm. Other EBV Reagents EBV - NA Reagents Candida albicans Other Mycology Immunoassays Other Mycology Immunoassays Neisseria meningitidis - NA Reagents Shigella - NA Reagents CMV - NA Reagents Rickettsia CYFRA 21-1 Pneumocystis carinii

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 54 of 108

GMDN Term

GMDN Code

34016 34044 34047 34048 34054 34055 34061 34062 34063 34064 34068 34069 34080 34088 34089 34093 34095 34098 34102 34103 34104 34111 34113 34114 34117 34118 34126 34135 34156 34166 34183 34184 34185 34186 34187 34220 34224 34225 34226 34381

EDMA Code

15 01 14 01 15 06 01 90 15 01 90 02 15 01 40 10 15 01 12 40 15 01 11 40 14 01 05 15 06 01 90 15 06 01 90 15 01 11 40 15 05 10 90 15 06 01 90 12 01 90 04 13 02 03 08 12 08 03 90 15 05 10 02 14 02 05 04 14 03 06 15 05 10 90 15 06 01 90 15 05 10 90 12 01 90 05 15 01 01 40 15 06 01 90 12 10 90 11 13 01 02 02 12 13 01 07 21 02 10 01 00 00 00 00 12 10 90 20 13 05 01 01 13 06 01 11 16 01 03 12 03 01 35 15 04 40 03 11 04 03 02 12 10 02 07 11 02 01 90 12 03 01 37 21 07 10 01

EDMA Term

Campylobacter Direct Antigen Detection Other Mycology Immunoassays Clostridium difficile Haemophilus influenzae - NA Reagents Staphylococci Detection by NA Reagents Streptococci Detection by NA Reagents Blood Culture - Manual Other Mycology Immunoassays Other Mycology Immunoassays Streptococci Detection by NA Reagents Other Parasitology Other Mycology Immunoassays a1-Microglobulin Prothrombin Fragment 1 + 2 Other Antibiotics TDM Chagas Mycobacteria Susceptibility Testing Susceptibility Testing (Mycology) Other Parasitology Other Mycology Immunoassays Other Parasitology Fibronectin Chlamydia Detection by NA Reagents Other Mycology Immunoassays Parietal Cell Antibodies Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Troponin (T + I) IC Hardware + dedicated accessories + software Not for IVD use Ribosomal Phosphoprotein Antibodies Antibodies for B and T-cell subtyping Interleukins (IL-1,IL-1A,IL-1B,.. - IL-15) Chromosomal Disorders Squamous Cell Carcinoma Antigen Human Papilloma Virus - NA Reagents Glucose - Electrodes Anti-MAG (Myelin Associated Glycoprotein) Other Substrates Prostatic Acid Phosphatase (IC) CC =>11.01.01.02 Diabetes Management Hardware + dedicated accessories + software

Campylobacter pylori DNA-probe, reagent, Histoplasma capsulatum Antigen, C. difficile DNA-probe, Haemophilus spp. DNA-probe, Staph aureus DNA-probe, Strep pneumoniae System, blood culturing DNA-probe, reagent, cryptococcal DNA-probe, reagent, Coccidioides immitis DNA-probe, reagent, streptococcal Elisa, Trichinella spiralis Antigen, ELISA, Cryptococcus Alpha-1 microglobulin, antigen, antiserum, control Prothrombin fragment 1.2 Isoniazid test strip Immunofluorescent assay, T. cruzi Susceptibility test powders, antimycobacterial Culture medium, antifungal, susceptibility test DNA probe, Trichomonas vaginalis EIA, Blastomyces dermatitidis DNA probe, Gardnerella vaginalis Enzyme immunoassay, foetal fibronectin DNA probe, nucleic acid amplification, Chlamydia DNA probe, yeast Enzyme immunoassay, antiparietal cell antibody, antigen, control Haemoglobin C, abnormal haemoglobin variant Immunoassay method, troponin subunit Device, semen analysis Irradiator, blood to prevent graft versus host disease Anti-ribosomal P antibody kit B/T lymphocyte nucleic acid kit Interleukin kit Human chromosome nucleic acid kit Test, squamous cell carcinoma Kit, DNA detection, human papillomavirus Sensor, glucose, invasive Kit, RIA, myelin basic protein Sialic acid kit Prostatic acid phosphatase kit Patient monitor, blood gas, transcutaneous

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 55 of 108

GMDN Term

Clinical chemistry test equipment Clinical chemistry automated analyser Centrifugal clinical chemistry automated analyser Analyser, clinical chemistry, dry Analyser, clinical chemistry, packed Clinical spectrophotometer Electrolyte analyser Flame photometer electrolyte analyser Coulometric electrolyte analyser Analyser, electrolyte, fluorometric Protein fraction electrophoresis instrument Immunophotometric instrument Immunoturbidimetric instrument Immunofluorometric instrument Lactate analyser Liquid chromatograph, special purpose Electrical resistance type blood cell counter Blood coagulation analyser Erythrocyte sedimentation rate test instrument Cell analyser Nuclear medical test instrument Medical specimen pre-treatment instrument Medical centrifuge Accessory, medical specimen pre-treatment instrument Urine gravimeter Analyser, microbiology Analyser, microbiology, microbe identification Analyser, microbiology, antibiotic susceptibility Automated histological analysis instrument Centrifuge, microhaematocrit Centrifuge, table-top Analyser, haematology, cell-quantifying, manual Analyser, alcohol Antibiotic susceptibility analyser Blood urea nitrogen analyser Coagulation analyser, automated Analyser, electrolyte, <specify> Analyser, enzyme Glucose analyser, laboratory Nitrogen analyser

GMDN Code

34546 34547 34548 34549 34550 34551 34552 34553 34554 34555 34556 34557 34558 34559 34560 34561 34562 34563 34564 34565 34566 34568 34569 34570 34571 34572 34573 34574 34575 34932 34933 35103 35464 35465 35466 35468 35469 35470 35471 35472

EDMA Code

21 01 10 01 21 01 10 01 21 01 10 01 21 01 10 01 21 01 10 01 21 01 10 01 21 04 10 01 21 04 10 01 21 04 10 01 21 04 10 01 21 05 10 01 21 02 10 01 21 02 10 01 21 02 10 01 21 01 10 01 21 05 10 02 23 01 10 01 23 02 10 01 23 09 10 01 23 01 10 01 26 01 10 01 28 01 10 01 28 01 10 01 28 01 10 01 21 01 10 01 24 01 10 01 24 01 10 01 24 01 10 01 23 05 10 01 23 09 10 01 28 01 10 01 23 01 10 01 21 07 10 09 24 01 10 01 21 01 10 01 23 02 10 01 21 04 10 01 21 01 10 01 21 01 10 01 21 01 10 01

EDMA Term

CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software EP Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software HPLC Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software Other_HHC Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software NA Hardware + dedicated accessories + software SP Hardware + accessories + software SP Hardware + accessories + software SP Hardware + accessories + software CH Hardware + dedicated accessories + software SI Hardware + dedicated accessories + software SI Hardware + dedicated accessories + software SI Hardware + dedicated accessories + software HC Hardware + dedicated accessories + software Other_HHC Hardware + dedicated accessories + software SP Hardware + accessories + software CC Hardware + dedicated accessories + software Other RT_CI Hardware + dedicated accessories + software SI Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 56 of 108

GMDN Term

Analyser, haematology, platelet aggregation Analyser, bilirubinometry Analyser, haematology, cell-quantifying, automated Information system, clinical laboratory Analyser, haematology, cell-differential Dispenser, slides Analyser, haematology, haemoglobin Pump, laboratory, high-pressure Analyser, haematology, sedimentation rate View box, Rh typing Analyser, immunoassay, radio-isotopic Analyser, clinical chemistry, <specify> Analyser, haematology, coagulation Blood gas/pH analyser Centrifuge tube adaptor Analyser, blood potassium Helium analyser Analyser, blood culture, automated Cell size analyser Analyser, haematology, blood grouping Analyser, immunoassay, enzyme Analyser, immunoassay, fluorescent Dispenser, disk, antimicrobial susceptibility test Dispenser, liquid, laboratory, manually-operated View box, ultraviolet Clinical chemistry analyser, automated Analyser, clinical chemistry, automated, discrete Analyser, clinical chemistry, centrifugal Analyser, clinical chemistry, flow Clinical chemistry analyser, manual Recorder, graphic, platelet aggregation Haematofluorometer Urine analyser, automated Radioimmunoassay analyser, automated Radioimmunoassay analyser, semiautomated Diluter, blood Analyser, electrolyte, flame photometer Analyser, photometer, reflectance Analyser, haematology, cell-analysis Centrifuge, cytology

GMDN Code

35473 35475 35476 35477 35479 35480 35481 35485 35488 35490 35506 35513 35514 35551 35554 35566 35603 35617 35627 35635 35706 35707 35733 35734 35736 35742 35743 35744 35745 35746 35769 35770 35772 35773 35774 35781 35826 35827 35835 35881

EDMA Code

23 02 10 01 21 01 10 01 23 01 10 01 29 01 10 01 23 01 10 01 23 05 30 01 23 09 10 01 00 00 00 00 23 09 10 01 23 03 10 01 21 02 10 01 21 01 10 01 23 02 10 01 21 04 10 01 28 01 10 01 21 04 10 01 00 00 00 00 24 02 10 01 23 01 10 01 23 03 10 01 21 02 10 01 21 02 10 01 24 01 30 01 28 01 10 01 23 03 10 01 21 01 10 01 21 01 10 01 21 01 10 01 21 01 10 01 21 01 10 01 23 02 10 01 23 09 10 01 21 01 10 01 21 02 10 01 21 02 10 01 23 01 30 01 21 04 10 01 21 07 10 09 23 01 10 01 28 01 10 01

EDMA Term

HS Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software Other Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software HC Consumables Other_HHC Hardware + dedicated accessories + software Not for IVD use Other_HHC Hardware + dedicated accessories + software BG Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software SP Hardware + accessories + software GE Hardware + dedicated accessories + software Not for IVD use BC & MB Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software BG Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software SI Consumables SP Hardware + accessories + software BG Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software Other_HHC Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software CC Consumables GE Hardware + dedicated accessories + software Other RT_CI Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software SP Hardware + accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 57 of 108

GMDN Term

Analyser, lactate Centrifuge, cell washing Analyser, ion selective Analyser, electrolyte, coulometric Radioimmunoassay analyser, manual Analyser, urine Urine analyser, semi-automated Analyser, immunoassay, light transmission Blood gas calibrator Analyser, calcium Semen analyser Culture medium, mycology Culture medium, viral cultivation/identification Decalcifying reagent Analyser, haematology, glycohaemoglobin Analyser, catecholamine Coagulation analyser, semi-automated Analyser, creatinine Alpha1-acid glycoprotein kit Reagent, alpha foetoprotein Reagent, anti-DNA antibody Reagent, Legionella spp. Myelin basic protein kit Reagent, haemopexin Hepatitis B virus/e antigen/antibody kit Reagent, heterophile, infectious mononucleosis, antibody Properdin factor B kit Culture medium, enriched Analyser, alcohol, breath Analyser, physiologic, fertility, thermometric Analyser, haematology, <specify> Haematology analyser, automated Haematology analyser, semiautomated Giardia lamblia kit Culture medium, transport Analyser, immunoassay, chemiluminescent Protective barrier strike-through detector Reagent, prostate, specific antigen, PSA Bath, wax Analyser, blood gas, transcutaneous

GMDN Code

35885 35901 35902 35903 35914 35918 35919 35926 35933 35937 35949 35960 35962 35963 35968 35989 35990 35991 36010 36011 36012 36013 36014 36015 36017 36018 36019 36030 36041 36110 36156 36157 36158 36173 36214 36223 36248 36300 36329 36346

EDMA Code

21 01 10 01 28 01 10 01 21 04 10 01 21 04 10 01 21 02 10 01 21 01 10 01 21 01 10 01 21 02 10 01 11 50 90 01 21 04 10 01 21 02 10 01 14 03 14 04 13 02 80 90 21 07 10 01 21 02 10 01 23 02 10 01 21 01 10 01 12 01 90 01 12 03 90 01 12 10 01 05 15 01 05 01 12 10 02 07 12 01 03 04 15 02 02 24 15 04 04 11 12 01 02 90 14 01 03 04 21 07 10 09 00 00 00 00 23 01 10 01 23 01 10 01 23 01 10 01 15 05 10 08 14 01 02 20 21 02 10 01 00 00 00 00 12 03 01 32 00 00 00 00 21 04 10 01

EDMA Term

CH Hardware + dedicated accessories + software SP Hardware + accessories + software GE Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software Blood gas control GE Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software Mycology Viral Culture Other Auxiliary Reagents (Haemostasis) Diabetes Management Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software a1-Acid Glycoprotein ( Orosomucoid ) Alphafetoprotein ds DNA - Antibodies Legionella Antigen Detection Anti-MAG (Myelin Associated Glycoprotein) Haemopexin Hepatitis Be Antibody (Total) Mononucleosis Inf. Imm.=> 15 70 90 03 Other Complement Components Enrichment media (Bottles) Other RT_CI Hardware + dedicated accessories + software Not for IVD use CC Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software CC Hardware + dedicated accessories + software Giardia lamblia Transport Media (Tubes) IC Hardware + dedicated accessories + software Not for IVD use Total Prostatic Specific Antigen Not for IVD use GE Hardware + dedicated accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 58 of 108

GMDN Term

Analyser, fluorescence Analyser, chromatograph, <specify> Laboratory equipment, washer, cell Laboratory equipment, diluter Analyser, photometer, atomic absorption Analyser, photometer, <specify> Analyser, photometer, flame emission Analyser, chromatograph, gas Analyser, photometer, luminescence Casting unit, laboratory, paraffin Alcoholmeter Laboratory equipment, incubator CO2 Analyser, chromatograph, high-pressure liquid chromatography Analyser, calorimeter Laboratory equipment, microtome freezer Laboratory equipment, microtome ultra Laboratory equipment, microtome general-purpose Analyser, osmometric Analyser, titration Laboratory equipment, centrifuge refrigerated Ultracentrifuge Centrifuge, general-purpose laboratory Scanning light densitometer Blood culture analyser, automated Analyser, amino acid Analyser, blood glucose Glycohaemoglobin analyser Calcium analyser Analyser, chloride Analyser, nitrogen Analyser, sperm/semen Analyser, haematology, thrombosis Analyser, viscosimetric Analyser, multichannel Analyser, photometer, general-purpose Analyser, chromatograph HPLC, compact Laboratory equipment, bunsen burner Analyser, photometer multifunction Analyser, fluorescence immunoassay automatic Laboratory equipment, centrifuge vacuum

GMDN Code

36396 36404 36407 36408 36409 36411 36413 36414 36415 36416 36417 36418 36420 36421 36443 36444 36447 36458 36459 36460 36461 36465 36604 36722 36724 36730 36734 36736 36738 36741 36744 36746 36823 36839 36910 36929 36934 36942 36944 36988

EDMA Code

21 04 10 01 21 05 10 02 28 01 10 01 28 01 10 01 21 04 10 01 21 01 10 01 21 04 10 01 00 00 00 00 21 02 10 01 13 07 01 04 23 07 10 01 24 09 10 01 21 05 10 02 00 00 00 00 23 05 10 01 23 05 10 01 23 05 10 01 00 00 00 00 00 00 00 00 28 01 10 01 28 01 10 01 28 01 10 01 21 05 10 01 24 02 10 01 21 02 10 01 21 01 10 01 21 07 10 01 21 01 10 01 21 04 10 01 00 00 00 00 21 02 10 01 23 02 10 01 00 00 00 00 21 01 10 01 21 01 10 01 21 05 10 02 00 00 00 00 21 01 10 01 21 02 10 01 28 01 10 01

EDMA Term

GE Hardware + dedicated accessories + software HPLC Hardware + dedicated accessories + software SP Hardware + accessories + software SP Hardware + accessories + software GE Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software Not for IVD use IC Hardware + dedicated accessories + software Embedding media (Histology/Cytology) RT_HHC Hardware + dedicated accessories + software Other_MCB Hardware + dedicated accessories + software HPLC Hardware + dedicated accessories + software Not for IVD use HC Hardware + dedicated accessories + software HC Hardware + dedicated accessories + software HC Hardware + dedicated accessories + software Not for IVD use Not for IVD use SP Hardware + accessories + software SP Hardware + accessories + software SP Hardware + accessories + software EP Hardware + dedicated accessories + software BC & MB Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software Diabetes Management Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software Not for IVD use IC Hardware + dedicated accessories + software HS Hardware + dedicated accessories + software Not for IVD use CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software HPLC Hardware + dedicated accessories + software Not for IVD use CH Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software SP Hardware + accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 59 of 108

GMDN Term

Laboratory equipment, refractometer Thermostat, laboratory Laboratory equipment, pump, high-pressure Analyser, microtitre plate reader Analyser, tensiometric Analyser, blood sedimentation Analyser, gas, helium Light-box, ultraviolet Analyser, haemoximetric Analyser, blood gas, subcutaneous Blood irradiator Laboratory equipment, centrifuge cyto Dialyser, analyser blood volume Analyser, blood gas, <specify> Analyser, gas, hydrogen Vitamin D kit, <specify> Test system, nicotine, cotinine, metabolites Apolipoprotein kit Prostate specific antigen kit Free prostate specific antigen kit Human immunodeficiency virus sample collection kit Reagent, thrombin Test, syphilis, treponemal Antibody, HTLV-1, ELISA Centrifuge rotor, ultracentrifuge Centrifuge rotor, adjustable angle Centrifuge rotor, fixed angle Centrifuge rotor, swinging bucket Laboratory equipment, casting unit, paraffin wax Titrator ACT meter Culture medium, <specify> Atomic absorption spectroscopy kit, <specify> Haemopexin control Albumin control Bordetella pertussis kit Anti-deoxyribonucleic acid antibody kit Anti-smooth muscle antibody kit Shigella kit Escherichia coli kit

GMDN Code

36992 37028 37033 37036 37056 37058 37063 37073 37078 37199 37211 37214 37218 37237 37252 37260 37270 37281 37286 37287 37288 37289 37290 37291 37530 37531 37532 37533 37537 37573 37702 37711 37719 37720 37721 37723 37724 37725 37726 37727

EDMA Code

00 00 00 00 00 00 00 00 00 00 00 00 21 02 10 01 00 00 00 00 23 09 10 01 00 00 00 00 00 00 00 00 00 00 00 00 21 04 10 01 00 00 00 00 28 01 10 01 00 00 00 00 21 04 10 01 00 00 00 00 12 06 03 10 12 09 01 08 12 01 04 21 12 03 01 32 12 03 01 33 25 01 30 01 13 02 01 03 15 01 03 03 15 03 30 04 28 01 10 01 28 01 10 01 28 01 10 01 28 01 10 01 23 05 10 01 00 00 00 00 23 02 10 01 14 01 01 01 11 03 01 90 12 50 01 06 12 01 03 01 15 01 90 07 12 10 01 05 12 10 01 11 15 01 90 14 15 01 15 01

EDMA Term

Not for IVD use Not for IVD use Not for IVD use IC Hardware + dedicated accessories + software Not for IVD use Other_HHC Hardware + dedicated accessories + software Not for IVD use Not for IVD use Not for IVD use GE Hardware + dedicated accessories + software Not for IVD use SP Hardware + accessories + software Not for IVD use GE Hardware + dedicated accessories + software Not for IVD use 25-Hydroxyvitamin D3 Cotinine Lipoprotein ( a ) Total Prostatic Specific Antigen Free Prostatic Specific Antigen II Consumables Thrombin Time / Reptilase / Batroxobin Time Syphilis Antibody Assays Total HTLV I Antibody SP Hardware + accessories + software SP Hardware + accessories + software SP Hardware + accessories + software SP Hardware + accessories + software HC Hardware + dedicated accessories + software Not for IVD use HS Hardware + dedicated accessories + software DCM (except susceptibility testing) Other Electrolytes Specific Protein Controls Albumin (IC) incl. uAlbumin CC =>11.02.01.01 Bordetella pertussis / parapertussis ds DNA - Antibodies Sm Shigella E. Coli Direct Antigen Detection

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 60 of 108

GMDN Term

Echovirus kit Coxsackievirus kit Equine encephalitis kit Poliovirus kit Reovirus kit Treponema total antibody control Histoplasma capsulatum kit Francisella tularensis kit Trichinella spiralis kit Blastomyces dermatitidis kit Parapertussis kit Coccidioides immitis kit Mumps virus kit Aspergillus kit Lymphocytic choriomeningitis virus kit Trypanosoma cruzi kit Cryptococcus neoformans kit Erysipelothrix rhusiopathiae kit Candida kit Neisseria kit Haemophilus kit Klebsiella kit Proteus kit Corynebacterium kit Antistreptolysin kit Antistaphylolysin kit Campylobacter kit Gardnerella vaginalis kit Fab fragment control FC fragment control Gamma globulin control Immunoglobulin E control Antiparietal cell antibody kit Bacillus subtilis kit Rabies virus kit Pipette, electronic, multifunction Analyser, aqueous/flare cell Slide stainer, cytology Slide stainer, manual Alphafoetoprotein control

GMDN Code

37728 37729 37730 37731 37732 37733 37734 37735 37736 37737 37738 37739 37740 37741 37742 37745 37746 37747 37748 37750 37751 37752 37753 37755 37756 37757 37758 37759 37760 37761 37762 37763 37765 37766 37767 37926 37948 37974 37975 38166

EDMA Code

15 04 80 90 15 04 80 90 15 04 80 90 15 04 80 90 15 04 80 90 15 50 01 01 15 01 90 90 15 05 10 90 15 06 01 90 15 06 01 90 15 01 90 07 15 06 01 90 15 04 80 08 15 06 01 01 15 04 80 13 15 05 10 02 15 06 01 90 15 01 90 90 15 06 01 02 15 01 90 11 15 01 90 10 15 01 90 90 15 01 90 12 15 01 90 08 12 11 01 04 12 11 01 06 15 01 14 01 15 05 10 90 12 50 01 06 12 50 01 06 12 50 01 06 12 50 01 06 12 10 90 11 14 02 03 01 15 04 80 90 00 00 00 00 00 00 00 00 23 05 10 01 23 05 10 01 12 50 01 10

EDMA Term

Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Bacteriology Controls - Inf.Imm. Other Other Bacteriology Immunoassays Other Parasitology Other Mycology Immunoassays Other Mycology Immunoassays Bordetella pertussis / parapertussis Other Mycology Immunoassays Mumps / Parotitis Aspergillus LCM Virus Chagas Other Mycology Immunoassays Other Other Bacteriology Immunoassays Candida albicans Neisseria meningitidis Haemophilus influenzae Other Other Bacteriology Immunoassays Proteus Diphteria (Corynebacterium D.) Anti-Streptolysin (quantitative) Anti-Staphylolysin (qualititative) Campylobacter Direct Antigen Detection Other Parasitology Specific Protein Controls Specific Protein Controls Specific Protein Controls Specific Protein Controls Parietal Cell Antibodies Serotyping (E.coli, Salmonella, Shigella, etc.) Other Viral Antigen/Antibody Detection Not for IVD use Not for IVD use HC Hardware + dedicated accessories + software HC Hardware + dedicated accessories + software Tumour Marker Controls

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 61 of 108

GMDN Term

Alphafoetoprotein calibrator Serotonin kit 5-hydroxyindoleacetic acid control 5-hydroxyindoleacetic acid calibrator Carcinoembryonic antigen control Carcinoembryonic antigen calibrator Cathepsin-D control Cathepsin-D calibrator Cytokeratin fragment 19 control Cytokeratin fragment 19 calibrator Oestrogen receptor assay Oestrogen receptor control Oestrogen receptor calibrator Free prostate specific antigen control Free prostate specific antigen calibrator Human placental alkaline phosphatase control Human placental alkaline phosphatase calibrator Laminin control Laminin calibrator Mucin-like carcinoma-associated antigen control Mucin-like carcinoma-associated antigen calibrator Neuron specific enolase control Neuron specific enolase calibrator Oncogene deoxyribonucleic acid probe control Oncogene deoxyribonucleic acid probe calibrator Oncogene protein control Oncogene protein calibrator Prostatic acid phosphatase control Prostatic acid phosphatase calibrator Progesterone receptor control Progesterone receptor calibrator Squamous cell carcinoma antigen control Squamous cell carcinoma antigen calibrator Thymidine kinase control Thymidine kinase calibrator TPA Tissue polypeptide antigen control Tissue polypeptide antigen calibrator Prostate specific antigen control Prostate specific antigen calibrator

GMDN Code

38167 38169 38170 38171 38173 38174 38175 38176 38177 38178 38179 38180 38181 38182 38183 38184 38185 38186 38187 38188 38189 38190 38191 38192 38193 38194 38195 38196 38197 38198 38199 38200 38201 38202 38203 38204 38205 38206 38207 38208

EDMA Code

12 50 01 09 12 03 90 17 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 03 02 01 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 03 01 36 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09

EDMA Term

Tumour Marker Standards / Calibrators Serotonine Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Estrogen Receptor Assays Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumor Polypeptide Antigen (TPA - incl. TPS) Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 62 of 108

GMDN Term

Bladder tissue antigen control Bladder tissue antigen calibrator Bladder tumour antigen BTA, rapid test Beta2-microglobulin control Beta2-microglobulin calibrator Faecal occult blood kit Faecal occult blood control Faecal occult blood calibrator Tissue-associated protein control Tissue-associated protein calibrator Cancer antigen 15-3 control Cancer antigen 15-3 calibrator Cancer antigen 19-9 control Cancer antigen 19-9 calibrator Cancer antigen 50 control Cancer antigen 50 calibrator Cancer antigen 72-4 control Cancer antigen 72-4 calibrator Cancer antigen 125 control Cancer antigen 125 calibrator Cancer antigen 195 control Cancer antigen 195 calibrator Cancer antigen 242 control Cancer antigen 242 calibrator Cancer antigen 549 control Cancer antigen 549 calibrator P53 kit P53 control P53 calibrator Vitamin D control, 1-25-dihydroxyvitamin D3 Vitamin D calibrator, 1-25-dihydroxyvitamin D3 Luteinizing hormone kit Luteinizing hormone control Oestradiol control Oestradiol calibrator Oestriol control Oestriol calibrator Oestrone control Oestrone calibrator

GMDN Code

38209 38210 38212 38213 38214 38215 38217 38218 38219 38220 38221 38222 38223 38224 38225 38226 38227 38228 38229 38230 38231 38232 38233 38234 38235 38236 38237 38238 38239 38240 38242 38243 38246 38247 38248 38249 38250 38251 38252 38253

EDMA Code

12 50 01 10 12 50 01 09 12 03 01 01 12 70 03 01 12 50 01 06 12 50 01 05 12 03 90 04 12 50 01 10 12 50 01 09 12 50 01 06 12 50 01 05 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 50 01 10 12 50 01 09 12 03 03 02 12 50 01 10 12 50 01 09 12 50 01 12 12 50 01 11 12 05 01 05 12 50 01 04 12 50 01 04 12 50 01 03 12 50 01 04 12 50 01 03 12 50 01 04 12 50 01 03

EDMA Term

Tumour Marker Controls Tumour Marker Standards / Calibrators Bladder Tissue Antigen BTA - Rapid Test Specific Protein Controls Specific Protein Standards / Calibrators Fecal Occult Blood (IC) CC =>11.70.03.01 Tumour Marker Controls Tumour Marker Standards / Calibrators Specific Protein Controls Specific Protein Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators Tumour Marker Controls Tumour Marker Standards / Calibrators p53 Tumour Marker Controls Tumour Marker Standards / Calibrators Anaemia Related/Vitamin Controls Anaemia Related/Vitamin Standards and Calibrators Luteinising Hormone Hormone Controls Hormone Controls Hormone Standards / Calibrators Hormone Controls Hormone Standards / Calibrators Hormone Controls Hormone Standards / Calibrators

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 63 of 108

GMDN Term

Follicle stimulating hormone control Follicle stimulating hormone calibrator Free oestriol control Free oestriol calibrator Free thyroxine control Free thyroxine calibrator Free triiodothyronine calibrator Total human chorionic gonadotrophin control Total human chorionic gonadotrophin calibrator Beta-human chorionic gonadotropin control Beta-human chorionic gonadotropin calibrator Human placental lactogen control Human placental lactogen calibrator Luteinizing hormone calibrator Thyroid stimulating hormone control Thyroid stimulating hormone calibrator Thyroxine binding globulin control Thyroxine binding globulin calibrator Listeria antigen kit Listeria nucleic acid kit Listeria antibody kit Chlamydia antigen control Chlamydia immunoglobulin A control Chlamydia immunoglobulin M control Chlamydia immunoglobulin G control Chlamydia total antibody control Chlamydia nucleic acid control Chlamydia total antibody calibrator Chlamydia antigen calibrator Chlamydia immunoglobulin A calibrator Chlamydia immunoglobulin G calibrator Chlamydia immunoglobulin M calibrator Chlamydia nucleic acid calibrator Clostridium difficile control Clostridium difficile calibrator Cytomegalovirus immunoglobulin M control Acid phosphatase total activity kit Aspartate aminotransferase total activity kit Amylase kit Creatine kinase total activity kit

GMDN Code

38254 38255 38256 38257 38258 38259 38261 38262 38263 38265 38266 38268 38269 38270 38271 38272 38273 38274 38277 38278 38279 38280 38281 38282 38283 38284 38285 38286 38287 38288 38289 38290 38291 38292 38293 38294 38498 38499 38502 38503

EDMA Code

12 50 01 04 12 50 01 03 12 50 01 04 12 50 01 03 12 50 01 04 12 50 01 03 12 50 01 03 12 50 01 04 12 50 01 03 12 50 01 04 12 50 01 03 12 50 01 04 12 50 01 03 12 50 01 03 12 50 01 04 12 50 01 03 12 50 01 04 12 50 01 03 15 01 13 11 15 01 13 40 15 01 13 13 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 04 11 01 01 02 11 01 01 10 11 01 01 07 11 01 01 13

EDMA Term

Hormone Controls Hormone Standards / Calibrators Hormone Controls Hormone Standards / Calibrators Hormone Controls Hormone Standards / Calibrators Hormone Standards / Calibrators Hormone Controls Hormone Standards / Calibrators Hormone Controls Hormone Standards / Calibrators Hormone Controls Hormone Standards / Calibrators Hormone Standards / Calibrators Hormone Controls Hormone Standards / Calibrators Hormone Controls Hormone Standards / Calibrators Listeria Monocytogenes direct Antigen detection Listeria Detection by NA Reagents Listeria Monocytogenes Antibody assays Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Acid Phosphatase (CC) IC => 12.03.01.37 Aspartate Amino-Transferase Amylase - Total Creatine Kinase - Total

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 64 of 108

GMDN Term

Lactate dehydrogenase total activity kit Lipase kit Cholinesterase kit Gamma-glutamyl transpeptidase kit Alkaline phosphatase isoenzyme kit Creatine kinase isoenzyme activity kit Electrode, ion-selective, uric acid Free fatty acids Pipette, manually-operated Ethanol test strip Alcohol control Magnesium electrode Digoxin control Digitoxin control Lidocaine control Methotrexate control N-acetylprocainamide control Theophylline control Aldolase kit Phospho-hexose isomerase kit 5'-nucleotidase kit Amylase isoenzyme kit Angiotensin converting enzyme kit Chymotrypsin kit Glutamate dehydrogenase kit Hydroxybutyrate dehydrogenase kit Leucine aminopeptidase kit Lysozyme kit Malate dehydrogenase kit N-acetyl-beta D-glucosaminidase kit Pepsin kit Sorbitol dehydrogenase kit Lactic acid, enzymatic method Activated partial thromboplastin time kit Alanine aminotransferase kit Sedimentation rate analyser, haematology Sample alternating system Sample processing system Blood gas monitor, oxygen General-purpose, analyser, photometer

GMDN Code

38504 38505 38506 38507 38511 38512 38519 38520 38522 38524 38527 38531 38532 38533 38534 38535 38536 38537 38538 38539 38540 38541 38542 38543 38544 38545 38546 38547 38548 38549 38550 38551 38552 38553 38556 38754 38756 38757 38760 38837

EDMA Code

11 01 01 19 11 01 01 23 11 01 01 11 11 01 01 16 11 01 01 06 11 01 01 15 11 04 03 90 11 02 01 22 00 00 00 00 12 70 09 90 12 50 01 02 11 04 01 05 12 50 01 02 12 50 01 02 12 50 01 02 12 50 01 02 12 50 01 02 12 50 01 02 11 01 01 04 11 01 01 28 11 01 01 01 11 01 01 08 12 06 02 03 11 01 01 12 11 01 01 17 11 01 01 18 11 01 01 22 11 01 01 24 11 01 01 25 11 01 01 26 11 01 01 27 11 01 01 29 11 02 01 18 13 02 01 02 11 01 01 03 23 09 10 01 28 01 10 01 28 01 10 01 21 04 10 01 21 01 10 01

EDMA Term

Lactate Dehydrogenase L ( LDH - L --> P ) Lipase Cholinesterase Gamma Glutamyltransferase Alkaline Phosphatase Isoenzymes(CC) IC => 12.06.03.01 Creatine Kinase Isoenzymes Other Substrate - Electrodes / Biosensors Non Esterified Fatty Acids Not for IVD use Other Drugs of Abuse/Toxicology Rapid Tests TDM/Drug Controls Magnesium - Electrodes TDM/Drug Controls TDM/Drug Controls TDM/Drug Controls TDM/Drug Controls TDM/Drug Controls TDM/Drug Controls Aldolase Phospho Hexose Isomerase 5'-Nucleotidase Amylase Isoenzyme Angiotensin Converting Enzyme (IC) CC =>11.01.01.09 Chymotrypsin Glutamate Dehydrogenase Hydroxybutyrate Dehydrogenase Leucine Aminopeptidase Lysozyme Malate Dehydrogenase N-acetyl-ß,D-Glucosaminidase Pepsin Sorbitol Dehydrogenase Lactate Activated Partial Thromboplastin Time Alanine Amino-Transferase Other_HHC Hardware + dedicated accessories + software SP Hardware + accessories + software SP Hardware + accessories + software GE Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 65 of 108

GMDN Term

GMDN Code

38851 38852 38854 38855 38857 38858 38859 38860 38862 38864 38865 38867 38870 38874 38875 38876 38877 38879 38883 38885 38886 38939 38941 38949 38950 38951 38952 38953 38954 38955 38956 38957 38958 38959 38960 38961 38962 38963 38964 38965

EDMA Code

15 01 02 03 24 01 30 01 15 01 02 03 12 01 90 05 12 03 02 02 12 03 02 01 12 08 06 01 12 10 02 07 12 03 01 09 24 01 30 01 12 08 06 01 11 02 01 21 15 04 03 07 12 03 02 01 15 04 03 10 15 01 90 09 15 04 80 09 11 02 01 13 11 03 01 06 00 00 00 00 00 00 00 00 21 04 10 01 21 04 10 01 12 06 05 04 12 03 90 17 12 06 05 04 11 70 02 01 11 02 01 32 12 04 01 05 11 02 01 04 12 06 90 90 11 02 01 31 12 05 01 10 11 02 01 31 11 02 01 35 11 02 01 30 11 02 01 24 11 70 02 01 11 03 01 08 12 05 01 05

EDMA Term

Gonococcal Antibody Assays Total SI Consumables Gonococcal Antibody Assays Total Fibronectin Progesterone Receptor Assays Estrogen Receptor Assays Cyclosporine Total Anti-MAG (Myelin Associated Glycoprotein) Cancer Antigen 549 SI Consumables Cyclosporine Total Low Density Lipoprotein Cholesterol HSV 1 Antibodies - Total Estrogen Receptor Assays HSV 2 Antibodies - Total Tetanus (Clostridium T.) Parvovirus B 19 Glucose Lithium Not for IVD use Not for IVD use GE Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software 17-Ketogenic Steroids Serotonine 17-Ketogenic Steroids Urine Single Test Strips (incl. tablets) Uric Acid Triiodothyronine Urea/Blood Urea Nitrogen Other Individual and Specified Hormones Triglycerides Testosterone (with Dehydro and Free Testosterone) Triglycerides Protein Electrophoresis Total Protein Phospholipids Urine Single Test Strips (incl. tablets) Phosphate inorganic / Phosphorus Luteinising Hormone

Kit, identification, Neisseria gonorrhoeae Susceptibility test disk, antimicrobial Gonococcal antibody test Enzyme immunoassay, fetal fibronectin Kit, assay, progesterone receptor Kit, assay, estrogen receptor Cyclosporine radioimmunoassay Test, myelin basic protein Antigen, cancer 549 Device, susceptibility, topical antimicrobial Cyclosporine Lipoprotein, low density, removal Enzyme linked immunosorbent assay, Herpes simplex virus, HSV-1 Immunohistochemistry antibody assay, estrogen receptor Enzyme linked immunosorbent assay, Herpes simplex virus, HSV-2 Clostridium tetani kit Parvovirus B19 IgG/IgM kit System, test, blood glucose, over the counter Assay, porphyrin, spectrophotometry, lithium Analyzer, gas, nitrogen, partial pressure, blood-phase, non-indwelling Analyzer, gas, helium, gaseous-phase Analyzer, ion, hydrogen-ion (pH), blood-phase, indwelling Analyzer, gas, oxygen, partial pressure, blood-phase, indwelling Zimmerman (spectrophotometric), 17-ketosteroid Acid, nitrous and nitrosonaphthol, 5-hydroxyindole acetic Chromatography separation/Zimmerman 17-ketogenic steroid Diazonium colorimetry, urobilinogen (urinary, non-quant.) Acid, uric, uricase (U.V.) Radioimmunoassay, total triiodothyronine Urease and glutamic dehydrogenase, urea nitrogen 1-nitroso-2-naphthol (fluorometric), free tyrosine Lipase hydrolysis/glycerol kinase enzyme, triglyceride Radioimmunoassay, testosterones and dihydrotestosterone TLC chromatographic separation triglyceride Electrophoretic, protein fractionation Biuret (colorimetric), total protein Ammonium molybdate and ammonium vanadate, phospholipid Dye-indicator, pH (urinary, non-quant.) Phosphomolybdate (colorimetric), inorganic phosphorus Radioimmunoassay, luteinizing hormone

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 66 of 108

GMDN Term

GMDN Code

38966 38967 38968 38969 38970 38971 38972 38973 38974 38975 38976 38977 38978 38979 38980 38981 38982 38983 38984 38985 38986 38987 38988 38989 38990 38991 38992 38993 38994 38995 38996 38997 38998 38999 39000 39001 39002 39003 39004 39005

EDMA Code

11 02 01 36 11 01 01 23 11 01 01 21 11 01 01 23 11 02 01 16 12 05 02 04 11 02 01 35 12 05 01 04 11 01 01 13 12 06 90 19 11 04 01 03 11 03 01 03 11 03 01 04 11 02 01 05 11 01 01 23 11 03 01 04 21 04 10 01 12 05 02 04 11 03 01 02 11 03 01 03 11 03 01 03 12 06 02 02 11 03 01 03 11 01 01 06 11 01 01 05 11 02 01 01 12 05 01 11 11 01 01 04 11 01 01 05 11 01 01 05 11 01 01 05 11 01 01 05 11 01 01 05 12 06 02 01 11 01 01 05 11 01 01 02 11 01 01 03 11 01 01 02 11 01 01 05 12 06 04 01

EDMA Term

Phenylketonuria Lipase Lactate Dehydrogenase Isoenzymes Lipase Iron (CC) IC =>12.07.01.04 Estrone Protein Electrophoresis Follicle Stimulating Hormone Creatine Kinase - Total Cyclic Guanosine Monophosphate Chloride - Electrodes Calcium Chloride Cholesterol Lipase Chloride GE Hardware + dedicated accessories + software Estrone Bicarbonate Calcium Calcium Angiotensin I / II Calcium Alkaline Phosphatase Isoenzymes(CC) IC => 12.06.03.01 Alkaline Phosphatase - Total Albumin (CC) IC =>12.01.03.01 Androsterone Aldolase Alkaline Phosphatase - Total Alkaline Phosphatase - Total Alkaline Phosphatase - Total Alkaline Phosphatase - Total Alkaline Phosphatase - Total Aldosterone Alkaline Phosphatase - Total Acid Phosphatase (CC) IC => 12.03.01.37 Alanine Amino-Transferase Acid Phosphatase (CC) IC => 12.03.01.37 Alkaline Phosphatase - Total Adrenocortiotropic Hormone

Chromogenesis, phenylketone (urinary, non-quant.) Olive oil emulsion (turbidimetric), lipase Chromatographic separation, lactate dehydrogenase isoenzyme Oil emulsion/thymolphthalein (titrimetric), lipase Bathophenanthroline, colorimetry, iron (non-heme) Radioimmunoassay, estrone Electrophoretic, globulin Radioimmunoassay, follicle-stimulating hormone NAD reduction/NADH oxidation, CPK or isoenzyme Radioimmunoassay, cyclic GMP Electrode, ion-specific, chloride Titrimetric permanganate and bromophenol blue, calcium Acid, phosphoric-tungstic (spectrophotometric), chloride Enzymatic esterase-oxidase, cholesterol Lipase-esterase, enzymatic, photometric, lipase Mercuric nitrate and diphenyl carbazone (titrimetric), chloride Analyzer, ion, hydrogen-ion (pH), blood phase, non-indwelling Radioimmunoassay, total estrogen in pregnancy Coulometric method, carbon-dioxide Titrimetric with EDTA and indicator, calcium DI (O-hydroxyphenylimine) ethane, calcium Radioimmunoassay, angiotensin I and renin Alizarin sulfonate, calcium Electrophoretic separation, alkaline phosphatase isoenzyme Thymolphthalein monophosphate, alkaline phosphatase or isoenzyme Bromcresol green dye-binding, albumin Radioimmunoassay, androsterone Fructose-1, 6-diphosphate and NADH (U.V.), aldolase Nitrophenylphosphate, alkaline phosphatase or isoenzyme Thymol blue monophosphate, alkaline phosphatase or isoenzyme Disodium phenylphosphate, alkaline phosphatase or isoenzyme Phenolphthalein phosphate, alkaline phosphatase or isoenzyme Beta glycerophosphate, alkaline phosphatase or isoenzyme Radioimmunoassay, aldosterone Alpha-naphthyl phosphate, alkaline phosphatase or isoenzyme Acid phosphatase, disodium phenylphosphate Vanillin pyruvate, ALT/SPGT Acid phosphatase, thymolphthalein monophosphate Phenylphosphate, alkaline phosphatase or isoenzyme Radioimmunoassay, ACTH

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 67 of 108

GMDN Term

GMDN Code

39006 39007 39008 39009 39010 39011 39012 39013 39014 39015 39016 39017 39018 39019 39020 39021 39022 39023 39024 39025 39026 39027 39028 39029 39030 39031 39032 39033 39034 39035 39036 39037 39038 39039 39040 39041 39042 39043 39044 39045

EDMA Code

12 01 90 06 12 01 01 20 12 01 03 04 12 01 03 04 12 01 02 03 12 01 03 04 12 01 02 01 12 01 02 07 12 01 02 07 12 01 02 01 12 01 02 01 13 01 02 02 12 01 01 07 13 02 05 02 12 01 01 06 13 02 05 02 12 01 01 06 13 02 05 02 12 01 90 90 13 02 05 02 12 01 02 07 13 02 05 02 12 01 02 02 12 01 90 90 12 10 01 11 12 01 02 05 12 10 90 11 12 10 90 02 13 02 02 14 12 01 90 90 12 11 01 09 12 01 90 90 12 01 90 90 12 10 90 04 12 10 90 04 12 01 90 03 13 02 05 05 12 01 90 03 12 01 90 03 12 01 90 06

EDMA Term

Trypsin-a1-Antitrypsin (Elastase) Kappa and Lambda chain Haemopexin Haemopexin Complement Component C3/C3c Haemopexin Complement Component C1q Complement Component C5-9 Complement Component C5-9 Complement Component C1q Complement Component C1q Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Immunoglobulin M Fibrinogen Degradation Products Immunoglobulin G subclass reagents Fibrinogen Degradation Products Immunoglobulin G subclass reagents Fibrinogen Degradation Products Other Other Plasma Proteins Fibrinogen Degradation Products Complement Component C5-9 Fibrinogen Degradation Products Complement Component C1 inactivator Other Other Plasma Proteins Sm Complement Component C4 Parietal Cell Antibodies Anti-Mitochondrial Antibodies Coagulation factor XIII Other Other Plasma Proteins C-Reactive Protein IC=> 12 70 11 01 Other Other Plasma Proteins Other Other Plasma Proteins Anti-ß2-Glycoprotein I Antibodies Anti-ß2-Glycoprotein I Antibodies a2-Macroglobulin Plasminogen a2-Macroglobulin a2-Macroglobulin Trypsin-a1-Antitrypsin (Elastase)

Inter-alpha trypsin inhibitor, antigen, antiserum, control Bence-jones protein, antigen, antiserum, control Hemopexin, rhodamine, antigen, antiserum, control Hemopexin, FITC, antigen, antiserum, control Complement C3, antigen, antiserum, control Hemopexin, antigen, antiserum, control Complement C1s, antigen, antiserum, control Complement C9, antigen, antiserum, control Complement C8, antigen, antiserum, control Complement C1r, antigen, antiserum, control Complement C1q, antigen, antiserum, control Hemoglobin, chain specific, antigen, antiserum, control IgM (mu chain specific), antigen, antiserum, control Fibrinogen and fibrin split product, antigen, antiserum, control IgG (Fd fragment specific), antigen, antiserum, control Fibrinogen and split product, rhodamine, antigen, antiserum, control IgG (Fc fragment specific), antigen, antiserum, control Fibrinogen and split product, peroxidase, antigen, antiserum, control Alpha-2-AP-glycoprotein, antigen, antiserum, control Fibrinogen and split product, FITC, antigen, antiserum, control Complement C5, antigen, antiserum, control Fibrinogen and split product, antigen, antiserum, control Complement C1 inhibitor (inactivator), antigen, antiserum, control Alpha 2, 2N-glycoprotein, antigen, antiserum, control Antismooth muscle antibody, indirect immunofluorescent, antigen, Complement C4, antigen, antiserum, control Antiparietal antibody, indirect immunofluorescent, antigen, control Antimitochondrial antibody, indirect immunofluorescent, antigen, Factor XIII A, S, antigen, antiserum, control Beta-globulin, antigen, antiserum, control C-reactive protein, antigen, antiserum, and control Alpha-globulin, antigen, antiserum, control Carbonic anhydrase B, antigen, antiserum, control Beta-2-glycoprotein III, antigen, antiserum, control Beta-2-glycoprotein I, antigen, antiserum, control Alpha-2-macroglobulin, rhodamine, antigen, antiserum, control Plasminogen, antigen, antiserum, control Alpha-2-macroglobulin, FITC, antigen, antiserum, control Alpha-2-macroglobulin, antigen, antiserum, control Inter-alpha trypsin inhibitor, FITC, antigen, antiserum, control

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 68 of 108

GMDN Term

GMDN Code

EDMA Code

12 01 90 90 12 01 90 90 12 01 90 01 12 01 04 21 12 01 90 01 12 01 90 02 11 02 01 21 12 01 90 90 11 50 90 03 12 01 01 06 12 01 01 06 12 01 90 90 12 05 02 90 13 02 05 05 12 10 01 01 12 09 02 07 14 02 03 01 11 70 01 90 11 02 01 09 12 09 01 06 12 09 01 12 12 09 01 10 12 08 03 04 12 09 01 02 12 09 01 12 12 08 02 90 12 08 02 90 12 08 01 01 14 02 03 01 12 08 03 90 12 09 02 90 12 09 01 09 12 08 02 90 11 01 01 11 12 09 01 06 12 09 01 12 21 01 10 01 12 09 01 13 12 09 01 03 12 09 02 07

EDMA Term

Other Other Plasma Proteins Other Other Plasma Proteins a1-Acid Glycoprotein ( Orosomucoid ) Lipoprotein ( a ) a1-Acid Glycoprotein ( Orosomucoid ) a1-Antitrypsin ( Protease inhibitor ) Low Density Lipoprotein Cholesterol Other Other Plasma Proteins CSF controls Immunoglobulin G subclass reagents Immunoglobulin G subclass reagents Other Other Plasma Proteins Other Pregnancy Testing Hormones Plasminogen ANA Screening Ethanol (Alcohol) Serotyping (E.coli, Salmonella, Shigella, etc.) Other Blood Test Strips Delta-Aminolaevulinic acid Cocaine + Cocaine Metabolites Morphines Methadone Gentamicin Amphetamine/Methamphetamine Specific (+Ecstasy) Morphines Other Central Nervous System TDM Other Central Nervous System TDM Digoxin Serotyping (E.coli, Salmonella, Shigella, etc.) Other Antibiotics TDM Other Toxicology Lysergic acid diethylamide Other Central Nervous System TDM Cholinesterase Cocaine + Cocaine Metabolites Morphines CH Hardware + dedicated accessories + software Opiates Barbiturates Ethanol (Alcohol)

Alpha-2-HS-glycoprotein, antigen, antiserum, control 39046 Alpha-2-glycoprotein, antigen, antiserum, control 39047 Alpha-1-T-glycoprotein, antigen, antiserum, control 39048 Alpha-1-lipoprotein, antigen, antiserum, control 39049 Alpha-1-B-glycoprotein, antigen, antiserum, control 39050 39051 Alpha-1-antitrypsin, rhodamine, antigen, antiserum, control Lipoprotein, low-density, antigen, antiserum, control 39052 Alpha-1-antichymotrypsin, antigen, antiserum, control 39053 39054 Total spinal-fluid, antigen, antiserum, control IgG (Fab fragment specific), antigen, antiserum, control 39055 39056 IgG (gamma chain specific), antigen, antiserum, control Seminal fluid, antigen, antiserum, control 39057 Breast milk, rhodamine, antigen, antiserum, control 39058 System, test, human chorionic gonadotropin 39060 Antinuclear antibody, indirect immunofluorescent, antigen, control 39061 Alcohol dehydrogenase, specific reagent for ethanol enzyme method 39062 Bacillus subtlis microbiology assay, tobramycin 39063 Cholinesterase test paper 39064 Lead, delta amino levulinic acid 39065 Enzyme immunoassay, cocaine and cocaine metabolite 39066 Radioimmunoassay, morphine (3-H), goat antibody ammonium sulfate 39067 Hemagglutination inhibition, methadone 39068 Radioimmunoassay, gentamicin (125-I), second antibody sep. 39069 Thin layer chromatography, metamphetamine 39070 Fluorometry, morphine 39071 Test reagent for phenothiazine 39072 Test reagent for chloral hydrate 39073 Antiserum, digoxin 39074 Bacillus subtlis, microbiological assay, gentamicin 39075 39076 Test reagent for sulphanimide derivative Test reagent for methyl alcohol 39077 Radioimmunoassay, LSD (125-I) 39078 Reagent, test, bromide 39079 Acetylcholine chloride, specific reagent for pseudo cholinesterase 39080 Hemagglutination, cocaine metabolite (benzoylecgnonine) 39081 Hemagglutination inhibition, morphine 39082 Gas chromatograph, alcohol (dedicated instrument) 39083 Hemagglutination, opiate 39084 39085 Hemagglutination inhibition, barbiturate Potassium dichromate specific reagent for alcohol 39086

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 69 of 108

GMDN Term

GMDN Code

EDMA Code

12 09 02 07 12 09 02 07 11 01 01 11 12 09 01 12 12 09 02 13 11 03 01 90 12 08 01 01 12 50 01 01 12 08 03 04 11 03 01 90 12 08 01 01 12 08 01 02 12 09 01 12 12 09 02 90 12 08 01 01 21 04 10 01 12 08 01 01 12 08 01 02 21 02 10 01 12 08 01 01 12 08 01 01 12 08 01 02 12 09 02 90 12 08 01 01 12 09 01 01 12 08 01 02 13 02 50 02 13 01 20 04 13 02 50 02 13 01 03 90 13 01 01 01 13 01 20 90 13 02 01 02 13 01 02 01 23 05 10 01 13 01 03 01 13 01 02 02 23 09 30 01 13 01 02 01 13 02 01 02

EDMA Term

Ethanol (Alcohol) Ethanol (Alcohol) Cholinesterase Morphines Salicylate Other Electrolytes Digoxin TDM/Drug Standards / Calibrators Gentamicin Other Electrolytes Digoxin Digitoxin Morphines Other Toxicology Digoxin GE Hardware + dedicated accessories + software Digoxin Digitoxin IC Hardware + dedicated accessories + software Digoxin Digoxin Digitoxin Other Toxicology Digoxin Amphetamines Group Digitoxin Control Plasmas Haemoglobin Control Control Plasmas Other Haematology stains CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) Other Haematology Controls Activated Partial Thromboplastin Time Haemoglobin determinations (Total Hb) HC Hardware + dedicated accessories + software Histo/Cyto stains Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Other_HHC Consumables Haemoglobin determinations (Total Hb) Activated Partial Thromboplastin Time

Test reagent for ethyl alcohol 39087 NAD-NADH, specific reagent for alcohol enzyme method 39088 Solution, m-nitrophenol, specific reagent for cholinesterase 39089 Radioimmunoassay, morphine-barbiturate (125-I), goat antibody 39090 Strip, paper, salicylate 39091 39092 Atomic absorption, antimony Radioimmunoassay, digoxin (125-I), goat antibody, 2nd antibody sep. 39093 Calibrator, ethyl alcohol 39094 39095 Hemagglutination inhibition, gentamicin Atomic absorption, arsenic 39096 Radioimmunoassay, digoxin (125-I), goat antibody, anion exchange, 39097 Radioimmunoassay, digitoxin (3-H) 39098 39099 Radioimmunoassay, morphine (125-I), goat antibody ammonium Lead, atomic absorption 39100 Radioimmunoassay, digoxin (125-I), rabbit antibody, solid phase sep. 39101 Mass spectrometer, clinical use 39102 Radioimmunoassay, digoxin (3-H), bovine antibody, charcoal sep. 39103 Radioimmunoassay, digitoxin (3-H), rabbit antibody, coated tube 39104 Fluorometer, lead (dedicated instruments) 39105 Radioimmunoassay, digoxin (3-H), goat antibody, 2nd antibody sep. 39106 Radioimmunoassay, digoxin (3-H), rabbit antibody, charcoal sep. 39107 Radioimmunoassay, digitoxin (125-I), rabbit antibody, coated tube sep. 39108 Mercury, atomic absorption 39109 Radioimmunoassay, digoxin (125-I), bovine antibody, charcoal sep. 39110 Radioimmunoassay, amphetamine (125-I), goat antibody, ammonium 39111 Radioimmunoassay, digitoxin (125-I), bovine antibody, charcoal sep. 39112 Fibrinogen determination standards and control 39411 Standards and control, hemoglobin, normal and abnormal 39412 Fibrinogen standard 39413 39414 Iron stain Fluid, diluting, white-cell 39415 Control, white-cell 39416 Reagent, thromboplastin and control 39417 Hemoglobin, alkali resistant 39418 Hemocytometer 39419 Stain, fetal hemoglobin 39420 Assay, carboxyhemoglobin 39421 Hematocrit, tube, rack, sealer, holder 39422 39423 Hemoglobin Reagent & control, partial thromboplastin time 39424

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 70 of 108

GMDN Term

GMDN Code

39425 39426 39427 39428 39429 39430 39431 39432 39433 39434 39435 39436 39438 39439 39440 39441 39442 39443 39444 39445 39446 39447 39448 39450 39452 39453 39454 39455 39456 39457 39458 39459 39460 39461 39463 39464 39465 39466 39467 39468

EDMA Code

13 01 02 02 13 01 03 01 13 01 03 01 13 01 01 01 13 01 20 03 13 01 02 01 13 01 02 01 23 09 10 01 23 09 10 01 13 01 02 01 23 09 10 01 13 01 20 90 15 06 01 90 15 06 01 90 15 06 01 90 15 50 01 06 15 06 01 90 15 50 01 06 15 06 01 90 15 05 10 01 15 50 01 01 15 01 90 90 15 01 03 03 15 01 15 01 15 01 90 14 15 01 10 01 15 04 80 90 15 05 10 06 15 04 80 90 15 04 80 90 15 04 80 90 15 04 80 90 15 04 80 90 15 04 80 90 15 04 80 04 15 04 80 04 15 04 80 04 15 04 80 04 15 04 80 04 15 04 80 01

EDMA Term

Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Histo/Cyto stains Histo/Cyto stains CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) Control Blood Multilevel Haemoglobin determinations (Total Hb) Haemoglobin determinations (Total Hb) Other_HHC Hardware + dedicated accessories + software Other_HHC Hardware + dedicated accessories + software Haemoglobin determinations (Total Hb) Other_HHC Hardware + dedicated accessories + software Other Haematology Controls Other Mycology Immunoassays Other Mycology Immunoassays Other Mycology Immunoassays Mycology Controls - Inf.Imm. Other Mycology Immunoassays Mycology Controls - Inf.Imm. Other Mycology Immunoassays Entamoeba histolytica Bacteriology Controls - Inf.Imm. Other Other Bacteriology Immunoassays Syphilis Antibody Assays Total E. Coli Direct Antigen Detection Shigella Salmonella Antigen Detection Other Viral Antigen/Antibody Detection Schistosoma Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Influenza & Para Influenza Influenza & Para Influenza Influenza & Para Influenza Influenza & Para Influenza Influenza & Para Influenza Adenovirus

Assay, sulfhemoglobin Stain, reticulocyte Stain, Heinz body Fluid, diluting, red-cell Control, red-cell Cyanomethemoglobin reagent and standard solution Abnormal hemoglobin quantitation Instrument, hematocrit, automated Centrifuge, hematocrit Cyanomethemoglobin System, hemoglobin, automated Control, hematocrit Antisera, fluorescent, Sporothrix schenekii Antisera, latex agglutination, Cryptococcus neoformans Antisera, fluorescent, Cryptococcus neoformans Antiserum, positive control, Coccidioides immitis Antigen, CF and/or ID, Coccidioides immitis Antiserum, positive control, Histoplasma capsulatum Antisera, fluorescent, Histoplasma capsulatum Antigen, latex agglutination, Entamoeba histolytica & rel. spp. Antisera, control for nontreponemal test Antigen, nontreponemal, all Sera, reactive and non-specific control, FTA-ABS test Antigen, all types, Escherichia coli Antisera, all types, Shigella spp. Antigen, febrile, slide and tube, all groups, Salmonella spp. Antigen, CF (including CF control), coxsackievirus A 1-24, B 1-6 Antigen, fluorescent antibody test, Schistosoma mansoni Antisera, neutralization, echovirus 1-34 Antisera, CF, echovirus 1-34 Antigen, CF (including CF control), echovirus 1-34 Antisera, fluorescent, coxsackievirus A 1-24, B 1-6 Antisera, neutralization, coxsackievirus A 1-24, B 1-6 Antisera, CF, coxsackievirus A 1-24, b 1-6 Antisera, neutralization, influenza virus A, B, C Antisera, HAI, influenza virus A, B, C Antigen, HA (including HA control), influenza virus A, B, C Antisera, CF, influenza virus A, B, C Antigen, CF (including CF control), influenza virus A, B, C Antisera, fluorescent, adenovirus 1-33

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 71 of 108

GMDN Term

GMDN Code

39469 39470 39471 39472 39473 39474 39475 39476 39477 39478 39479 39480 39481 39482 39483 39484 39485 39486 39487 39488 39489 39490 39491 39492 39493 39494 39495 39496 39497 39498 39499 39500 39501 39502 39503 39504 39505 39506 39507 39508

EDMA Code

15 04 80 01 15 04 80 01 15 04 80 01 15 04 80 01 15 04 80 01 15 04 80 90 15 04 80 90 15 04 80 90 15 04 80 90 15 04 01 04 15 04 01 04 15 04 01 04 15 01 10 03 15 01 90 90 15 01 90 07 15 01 90 07 15 01 90 07 15 06 01 90 15 05 10 04 15 05 10 90 15 01 90 05 15 01 01 90 15 04 80 90 15 04 80 90 15 04 80 90 15 04 80 90 15 04 80 90 15 04 80 90 15 04 80 90 15 04 80 90 15 04 80 05 15 04 80 05 15 04 02 01 15 04 03 04 15 04 03 04 15 04 03 01 15 04 03 04 15 04 80 04 15 04 80 04 15 04 80 04

EDMA Term

Adenovirus Adenovirus Adenovirus Adenovirus Adenovirus Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Rubella Virus Antibodies - Total Rubella Virus Antibodies - Total Rubella Virus Antibodies - Total Salmonella Antibody Assays Other Other Bacteriology Immunoassays Bordetella pertussis / parapertussis Bordetella pertussis / parapertussis Bordetella pertussis / parapertussis Other Mycology Immunoassays Echinococcus Other Parasitology Rickettsia Other Chlamydia Reagents Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Other Viral Antigen/Antibody Detection Respiratory Syncytial Virus (RSV) Respiratory Syncytial Virus (RSV) CMV Antigen HSV Antibodies - Total HSV Antibodies - Total HSV Antigen HSV Antibodies - Total Influenza & Para Influenza Influenza & Para Influenza Influenza & Para Influenza

Antisera, neutralization, adenovirus 1-33 Antisera, CF, adenovirus 1-33 Antigen, HA (including HA control), adenovirus 1-33 Antisera, HAI, adenovirus 1-33 Antigen, CF (including CF control), adenovirus 1-33 Antisera, fluorescent, poliovirus 1-3 Antisera, neutralization, poliovirus 1-3 Antisera, CF, poliovirus 1-3 Antigen, CF (including CF control), poliovirus 1-3 Antisera, neutralization, rubella Antisera, HAI (including HAI control), rubella Antisera, CF, rubella Antisera, fluorescent, all globulins, Salmonella spp. Antisera, C. acnes (553, 605) Antisera, agglutinating, B. parapertussis Antisera, agglutinating, B. pertussis, all Antisera, fluorescent, B. pertussis Antisera, positive control, Echinococcus spp. Antigen, agglutinating, Echinococcus spp. Antiserum, bentonite flocculation, Trichinella spiralis Antiserum, rickettsialpox Antigen, CF, psittacosis (Chlamydia group) Antisera, neutralizion, reovirus 1-3 Antisera, HAI, reovirus 1-3 Antisera, CF, reovirus 1-3 Antigen, HA (including HA control), reovirus 1-3 Antigen, CF (including CF control), reovirus 1-3 Antisera, CF, equine encephalitis virus, EEE, WEE Antigen, CF (including CF control), equine encephalitis virus, EEE, Antisera, neutralization, all types, rhinovirus Antiserum, neutralization, respiratory syncytial virus Antigen, CF (including CF controls), respiratory syncytial virus Antigen, CF (including CF control), cytomegalovirus Antisera, fluorescent, herpesvirus hominis 1,2 Antisera, neutralization, Herpesvirus hominis Antigen, CF (including CF control), herpesvirus hominis 1,2 Antisera, CF, herpesvirus hominis 1, 2 Antisera, neutralization, parainfluenza virus 1-4 Antisera, HAI, parainfluenza virus 1-4 Antigen, HA (including HA control), parainfluenza virus 1-4

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 72 of 108

GMDN Term

Antigen, CF (including CF control), parainfluenza virus 1-4 Antisera, CF, parainfluenza virus 1-4 Antigen, CF, (including CF control), varicella-zoster Antiserum, CF, varicella-zoster Antigen, HA (including HA control), mumps virus Antiserum, neutralization, mumps virus Antigen, CF (including CF control), mumps virus Antiserum, neutralization, rubeola Antisera, fluorescent, echovirus 1-34 Antigen, all groups, Salmonella spp. Antisera, all groups, Salmonella spp. Antisera, fluorescent, all types, Hemophilus spp. Antisera, all types, H. influenza Antisera, all fluorescent, Leptospira spp. Antisera, all Leptospira spp. Antigen, all, Leptospira spp. Antisera, fluorescent, all, Mycoplasma spp. Antisera, all Mycoplasma spp. Antigen, CF, all, Mycoplasma spp. Antisera, fluorescent, all types, Listeria monocytogenes Antisera, all types, Listeria monocytogenes Antigen, slide and tube, all types, Listeria monocytogenes Antigen, slide and tube, Francisella tularensis Antisera, fluorescent, Brucella spp. Antiserum, positive and negative febrile antigen control serum Antigens (febrile), agglutination, Brucella spp. Antiserum, Vibrio cholerae, all varieties Antisera, fluorescent, Pseudomonas pseudomallei Antisera, fluorescent, Pseudomonas aeruginosa Antiserum, Flavobacterium meningosepticum, all groups Antisera, Acinetobacter calcoaceticus, all varieties Antisera, fluorescent, all globulins, Proteus spp. Antigen, febrile (Weil-Felix), all groups Antisera, all, Serratia marcesans Antisera, fluorescent, all types, Klebsiella spp. Antisera, all types, Klebsiella spp. Antisera, fluorescent, all globulins, Shigella spp. Antisera, Arizona spp., all Antisera, Bethesda - ballerup polyvalent, Citrobacter spp. Antisera, fluorescent, all groups, N. meningitidis

GMDN Code

39509 39510 39511 39512 39513 39514 39515 39517 39519 39520 39521 39522 39523 39524 39525 39526 39527 39528 39529 39530 39531 39532 39533 39534 39535 39536 39537 39538 39539 39540 39541 39542 39543 39544 39545 39546 39547 39548 39549 39550

EDMA Code

15 04 80 04 15 04 80 04 15 04 80 10 15 04 80 10 15 04 80 08 15 04 80 08 15 04 80 08 15 04 01 04 15 04 80 90 15 01 10 01 15 01 10 03 15 01 90 90 15 04 80 04 15 01 90 04 15 01 90 04 15 01 90 04 15 01 08 03 15 01 08 03 15 01 08 01 15 01 13 13 15 01 13 13 15 01 13 11 15 01 90 90 15 01 90 01 15 50 01 01 15 01 90 01 15 01 90 90 15 01 90 13 15 01 09 03 15 01 90 90 15 01 90 90 15 01 90 12 15 01 90 12 15 01 90 90 15 01 90 90 15 01 90 90 15 01 90 14 15 01 90 90 15 01 90 90 15 01 90 11

EDMA Term

Influenza & Para Influenza Influenza & Para Influenza Varicella Zoster Varicella Zoster Mumps / Parotitis Mumps / Parotitis Mumps / Parotitis Rubella Virus Antibodies - Total Other Viral Antigen/Antibody Detection Salmonella Antigen Detection Salmonella Antibody Assays Other Other Bacteriology Immunoassays Influenza & Para Influenza Leptospira Leptospira Leptospira Mycoplasma Antibody Assays Mycoplasma Antibody Assays Mycoplasma Antigen Detection Listeria Monocytogenes Antibody assays Listeria Monocytogenes Antibody assays Listeria Monocytogenes direct Antigen detection Other Other Bacteriology Immunoassays Brucella Bacteriology Controls - Inf.Imm. Brucella Other Other Bacteriology Immunoassays Pseudomonas Pseudomonas Aeruginosa Antibody IgG Other Other Bacteriology Immunoassays Other Other Bacteriology Immunoassays Proteus Proteus Other Other Bacteriology Immunoassays Other Other Bacteriology Immunoassays Other Other Bacteriology Immunoassays Shigella Other Other Bacteriology Immunoassays Other Other Bacteriology Immunoassays Neisseria meningitidis

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 73 of 108

GMDN Term

GMDN Code

39551 39552 39553 39558 39725 39726 39727 39728 39729 39730 39731 39732 39733 39734 39735 39736 39737 39738 39739 39740 39741 39742 39744 39745 39746 39747 39748 39749 39750 39751 39752 39753 39754 39755 39756 39757 39758 39759 39760 39761

EDMA Code

15 01 90 11 12 11 01 05 15 01 11 40 15 05 10 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01

EDMA Term

Neisseria meningitidis Anti-Streptolysin/Anti-Streptolysin O (qualitative) Streptococci Detection by NA Reagents Entamoeba histolytica Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains

Antisera, all groups, N. meningitidis Antistreptolysin - titer/streptolysin O reagent Antideoxyribonuclease, Streptococcus spp. Indirect fluorescent antibody test, Entamoeba histolytica & rel sp Eosin Y Fast green Fast red salt B Hematoxylin Harris's Hematoxylin Mayer's Hematoxylin Weigert's Stain, trichrome, Mallory's Methenamine silver Acid, osmic Stain, Papanicolau Stain, Ponceau Reagent, Schiff Van Gieson's stain Hematoxylin, iron, Weigert's Wright's stain Solution, Lugol's Collodion Colchicine Eosin B Darrow red Crystal violet for histology Cresyl violet acetate Congo red Carbol night blue Carbol fuchsin Brilliant yellow Biebrich scarlet Azure A Azocarmine B Azocarmine G Aniline Acid, aniline, fuchsin Ammoniacal silver hydroxide silver nitrate Alcian blue Aldehyde fuchsin Acridine orange

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 74 of 108

GMDN Term

GMDN Code

39762 39763 39764 39766 39767 39768 39769 39770 39771 39818 39819 39820 39821 39822 39823 39824 39825 39826 39827 39828 39829 39830 39831 39841 39842 39851 39852 39853 39854 39855 39856 39857 39858 39859 39860 39861 39862 39863 39864 39865

EDMA Code

13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 02 01 13 01 02 01 13 01 09 01 13 01 09 01 13 01 09 01 13 01 09 01 13 01 09 01 13 01 09 01 13 01 09 01 13 01 09 01 13 01 09 01 13 02 01 04 11 01 01 05 13 01 20 04 00 00 00 00 00 00 00 00 12 03 01 37 11 03 01 03 11 02 01 01 11 01 01 19 11 01 01 22 11 03 01 07 11 02 01 36 11 02 01 30 11 02 01 32 11 02 01 32 11 02 01 32 11 02 01 19 11 02 01 90 12 05 02 05 12 05 02 05

EDMA Term

Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Haemoglobin determinations (Total Hb) Haemoglobin determinations (Total Hb) Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Activated Clotting Time Alkaline Phosphatase - Total Haemoglobin Control Not for IVD use Not for IVD use Prostatic Acid Phosphatase (IC) CC =>11.01.01.02 Calcium Albumin (CC) IC =>12.01.03.01 Lactate Dehydrogenase L ( LDH - L --> P ) Leucine Aminopeptidase Magnesium Phenylketonuria Total Protein Uric Acid Uric Acid Uric Acid Lecithin Other Substrates Human Chorionic Gonadotropin Total Human Chorionic Gonadotropin Total

Alizarin red Acid, hematein Acid, fuchsin Solution, Zenker's Solution, Orth's Solution, Helly Formaldehyde (formalin, formol) Solution, Carnoy's Fluid, Bouin's Solubility, hemoglobin, abnormal System, analysis, electrophoretic hemoglobin Cell enzymes (erythrocytic and leukocytic) Glucose-6-phosphate dehydrogenase (erythrocytic), screening Glucose-6-phosphate dehydrogenase (erythrocytic), spot Glucose-6-phosphate dehydrogenase (erythrocytic), micromethod Glucose-6-phosphate dehydrogenase (erythrocytic), catalase inhibition Glucose-6-phosphate dehydrogenase (erythrocytic), methemoglobin Glucose-6-phosphate dehydrogenase (erythrocytic), U.V. kinetic Glucose-6-phosphate dehydrogenase (erythrocytic), quantitative Glucose-6-phosphate dehydrogenase (erythrocytic), electrophoresis Activated whole blood clotting time Alkaline phosphatase Control, hemoglobin, abnormal Analyzer, gas, neon, gaseous-phase Analyzer, gas, argon, gaseous-phase Acid phosphatase (prostatic), tartrate inhibited Atomic absorption, calcium Tryptophan measurement (colorimetric), globulin Differential rate kinetic method, lactate dehydrogenase isoenzyme L-leucine-4-nitroanilide (colorimetric), leucine arylamidase Atomic absorption, magnesium Ferric chloride, phenylketones (urinary, non-quant.) Lowry (colorimetric), total protein Acid, uric, uricase (gasometric) Acid, uric, uricase (colorimetric) Acid, uric, uricase (oxygen rate) Colorimetric method, lecithin/sphingomyelin ratio Chromatographic separation, lecithin/sphingomyelin ratio Radioimmunoassay, human chorionic gonadotropin Agglutination method, human chorionic gonadotropin

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 75 of 108

GMDN Term

GMDN Code

EDMA Code

11 02 01 20 11 01 01 13 11 01 01 13 11 01 01 13 11 01 01 13 11 02 01 12 11 04 01 01 11 03 01 06 11 03 01 06 12 04 01 90 11 70 02 01 11 70 02 01 11 70 02 01 11 70 02 01 11 70 02 01 11 02 01 16 11 02 01 16 12 07 01 04 11 70 02 90 21 01 10 01 21 01 10 01 21 01 10 01 21 01 10 01 21 01 10 01 21 04 10 01 11 50 90 01 11 50 02 01 12 05 01 14 12 05 01 02 12 06 01 01 11 01 01 18 11 01 01 90 12 01 01 20 00 00 00 00 12 08 02 90 13 01 02 02 11 30 04 01 12 06 90 90 12 06 90 90 13 01 09 01

EDMA Term

Lipoprotein, Chemical determination/detection Creatine Kinase - Total Creatine Kinase - Total Creatine Kinase - Total Creatine Kinase - Total Galactose Ammonia - Electrodes Lithium Lithium Other thyroid hormones Urine Single Test Strips (incl. tablets) Urine Single Test Strips (incl. tablets) Urine Single Test Strips (incl. tablets) Urine Single Test Strips (incl. tablets) Urine Single Test Strips (incl. tablets) Iron (CC) IC =>12.07.01.04 Iron (CC) IC =>12.07.01.04 Iron (IC) CC =>11.02.01.16 Other Urine Testing CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software GE Hardware + dedicated accessories + software Blood gas control Enzyme Control Sera 11-Desoxycortisol Dehydro-epiandrosterone Sulphate (incl. DHEA) C-Peptide Hydroxybutyrate Dehydrogenase Other Enzymes Kappa and Lambda chain Not for IVD use Other Central Nervous System TDM Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Multiple Enzymes only - Electrodes/Biosensors Other Individual and Specified Hormones Other Individual and Specified Hormones Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase)

Colorimetric method, lipoprotein 39866 Differential rate kinetic method, CPK or isoenzyme 39867 U.V. method, CPK isoenzyme 39868 Fluorometric method, CPK or isoenzyme 39869 Colorimetric method, CPK or isoenzyme 39870 39871 U.V. method, galactose Electrode, ion-specific method, ammonia 39872 Flame photometer, lithium 39873 39874 Atomic absorption, lithium Dry ash method, protein-bound iodine 39875 39876 Method, enzymatic, glucose (urinary, non-quantitative) Method, metallic reduction, glucose (urinary, non-quantitative) 39877 Nitroprusside, ketone (urinary, non-quant.) 39878 Blood, occult, colorimetric, in urine 39879 Indicator method, protein or albumin (urinary, non-quant.) 39880 Photometric method, iron (non-heme) 39881 Atomic absorption, iron (non-heme) 39882 Radio-labeled iron method, iron (non-heme) 39883 Azo-dye, colorimetric, bilirubin & its conjugates (urinary, non-quant.) 39884 Analyzer, chemistry (sequential multiple, continuous flow) clinical use 39885 Analyzer, chemistry (photometric, discrete), for clinical use 39886 Analyzer, chemistry, micro, for clinical use 39887 Analyzer, chemistry, centrifugal, for clinical use 39888 Analyzer, enzyme, for clinical use 39889 Flame emission photometer for clinical use 39890 Control for blood-gas, (assayed and unassayed) 39891 Enzyme controls (assayed and unassayed) 39892 Radioimmunoassay, compound S (11-deoxycortisol) 39893 Radioimmunoassay, dehydroepiandrosterone (free and sulfate) 39894 39895 Radioimmunoassay, C-peptide of proinsulin Dinitrophenyl hydrazone measurement (colorimetric), hydroxybutyric 39896 L-isocitrate and NADP (U.V.), isocitric dehydrogenase 39897 Immunochemical, bence-jones protein 39898 Chromium-51, blood volume 39899 Gold chloride (colorimetric), bromide 39900 Spectral absorb. curve, oxyhemoglobin, carboxyhemoglobin, carbon- 39901 ATP and creatine kinase (enzymatic), creatine 39903 Nitroprusside reaction (qualitative, urine), cystine 39904 39905 Chromatographic, cystine Isoenzyme, electrophoretic, glucose-6-phosphate dehydrogenase 39906

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 76 of 108

GMDN Term

GMDN Code

39907 39908 39909 39910 39911 39912 39913 39914 39915 39916 39917 39918 39919 39920 39921 39922 39923 39924 39925 39926 39927 39928 39929 39930 39938 39939 39940 39941 39942 39943 39944 39945 39946 39947 39948 39949 39951 39952 39953 39954

EDMA Code

13 01 09 01 12 05 01 07 12 05 01 06 13 01 09 01 11 02 01 90 13 01 09 01 12 05 02 04 12 07 01 02 12 06 90 90 11 01 01 18 11 02 01 17 11 01 01 24 11 01 01 24 11 01 01 25 11 70 02 01 12 06 90 90 12 06 90 90 11 01 01 28 12 05 02 90 11 01 01 29 11 01 01 30 00 00 00 00 11 02 01 24 12 07 02 90 23 02 10 01 13 01 02 02 13 01 02 02 13 01 02 02 13 02 01 01 23 09 10 01 11 01 01 16 11 02 01 17 12 06 90 90 21 05 10 01 11 02 01 90 11 02 01 90 15 01 90 07 15 04 04 04 14 02 05 01 14 02 05 01

EDMA Term

Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) 17 OH Progesterone Progesterone Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Other Substrates Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Estrone Ferritin Other Individual and Specified Hormones Hydroxybutyrate Dehydrogenase Iron Binding Capacity - Total (CC) IC =>12.07.01.05 Lysozyme Lysozyme Malate Dehydrogenase Urine Single Test Strips (incl. tablets) Other Individual and Specified Hormones Other Individual and Specified Hormones Phospho Hexose Isomerase Other Pregnancy Testing Hormones Sorbitol Dehydrogenase Trypsin (CC) IC =>12.01.90.07 Not for IVD use Phospholipids Other Vitamin Tests HS Hardware + dedicated accessories + software Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Prothrombin time ( Quick Test ) Other_HHC Hardware + dedicated accessories + software Gamma Glutamyltransferase Iron Binding Capacity - Total (CC) IC =>12.07.01.05 Other Individual and Specified Hormones EP Hardware + dedicated accessories + software Other Substrates Other Substrates Bordetella pertussis / parapertussis EBV Antibodies MIC Systems - Manual MIC Systems - Manual

Enzymatic (glutathione reductase), glutathione Gas chromatography, pregnanetriol Radioimmunoassay, progesterone NADH, phosphoglycerate mutase, ATP (U.V.) 2,3-diphosphoglyceric Acid, ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric) NADP reduction (U.V.), glucose-6-phosphate dehydrogenase Radioimmunoassay, total estrogen, nonpregnancy Radioimmunoassay (two-site solid phase), ferritin Chromatographic, histidine Acid, alpha-ketobutyric and NADH (U.V.), hydroxybutyric Ferrozine (colorimetric) iron binding capacity M. lysodeikticus cell (spectrophotometric), lysozyme (muramidase) Immunochemical, lysozyme (muramidase) Acid, oxalacetic and nadh oxidation (U.V.), malic dehydrogenase Diazo (colorimetric), nitrite (urinary, non-quant) 2,4-dinitrofluorobenzene (spectroscopic), nitrogen (amino-nitrogen) Ninhydrin, nitrogen (amino-nitrogen) Glucose-6-phosphate (colorimetric), phosphohexose isomerase Radioimmunoassay, pregnenolone Beta-D-fructose & NADH oxidation (U.V.), sorbitol dehydrogenase N-benzoyl-l-arginine ethyl ester (U.V.), trypsin Infrared spectroscopy measurement, urinary calculi (stone) Stannous chloride - hydrazine, phospholipid Acid, trifluoroacetic, vitamin A, hexane extraction Analyzer, heparin, automated Hemoglobin M Hemoglobin F quantitation Hemoglobin A2 quantitation Prothrombin-proconvertin and thrombotest Device, hematocrit measuring Electrophoretic, gamma-glutamyl transpeptidase isoenzyme Resin, ion-exchange, ascorbic acid, colorimetry, iron binding capacity Trinitrobenzene sulfonate (spectroscopic), nitrogen (amino-nitrogen) Densitometeric, protein fractionation Spectrophotometric, uroporphyrin Colorimetric, mucopolysaccharide Antisera, fluorescent, B. parapertussis Antiserum, fluorescent, Epstein-Barr virus Media, culture, amino acid assay Culture media, antibiotic assay

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 77 of 108

GMDN Term

Culture media, vitamin assay Culture media, general nutrient broth Culture media, selective broth Culture media, multiple biochemical test Culture media, non-selective and non-differential Culture media, non-selective and differential Culture media, selective and differential Culture media, selective and non-differential Supplement, culture media Culture media, anaerobic transport Culture media, non-propagating transport Culture media, propagating transport Kit, identification, dermatophyte Kit, identification, Enterobacteriaceae Kit, fastidious organism Kit, identification, glucose nonfermenter Susceptibility test disc, antimicrobial Kit, quality control for culture media Culture media, for isolation of pathogenic Neisseria Culture media, antimicrobial susceptibility test, Mueller Hinton Antigen, positive control, Cryptococcus neoformans Device, blood volume measuring ATP release (luminescence) Antigen, CF, Aspergillus spp. Kit, screening, Trichomonas Enzyme immunoassay, benzodiazipine Factor B, antigen, antiserum, control Agent, chelating for decalcification Osmium tetroxide Paraformaldehyde Media, mounting, oil soluble Media, mounting, water soluble Methylene blue, tissue stain Aniline blue Antiserum, positive control, Aspergillus spp. Antiserum, positive control, Blastomyces dermatitidis Adenine nucleotide quantitation Whole blood hemoglobin determination Antigen, ID, HA, CEP, Entamoeba histolytica & rel. spp. Slide stainer, contact type

GMDN Code

39955 39956 39957 39958 39959 39960 39961 39962 39963 39964 39965 39966 39967 39968 39969 39970 39971 39972 39973 39974 39975 39976 39977 39978 39979 39981 39993 40016 40017 40018 40020 40021 40022 40023 40024 40025 40039 40040 40045 40050

EDMA Code

14 90 90 90 14 01 02 01 14 01 02 01 14 02 02 90 14 01 14 01 14 01 14 01 14 01 01 04 24 09 30 01 24 09 30 01 24 09 30 01 14 03 04 90 14 02 02 01 14 02 02 90 14 02 02 02 24 01 30 01 14 01 08 90 14 02 02 06 14 02 05 01 15 06 01 90 23 09 10 01 12 12 01 90 15 06 01 01 15 05 10 90 12 09 01 04 12 01 02 90 13 02 80 90 00 00 00 00 00 00 00 00 13 07 01 06 13 07 01 06 13 01 03 01 13 01 03 01 15 50 01 06 15 50 01 06 13 01 09 01 13 01 02 01 15 05 10 01 23 05 10 01

EDMA Term

Other Other Microbiology Tests Broth Media (Tubes) Broth Media (Tubes) Other Manual Identification (Optichin, Bacitracin etc.) Bacteriology - Culture Bacteriology - Culture Bacteriology - Culture Bacteriology - Culture Additives for DCM Other_MCB Consumables Other_MCB Consumables Other_MCB Consumables Other Identification Systems for Yeasts and Fungi - Automated Enterobacteriaceae - Manual Other Manual Identification (Optichin, Bacitracin etc.) Non-fermenters - Manual SI Consumables Miscellaneous Buffers, Controls and Standards Haemophilus & Neisseria - Manual MIC Systems - Manual Other Mycology Immunoassays Other_HHC Hardware + dedicated accessories + software Other Liver Function Aspergillus Other Parasitology Benzodiazepines Other Complement Components Other Auxiliary Reagents (Haemostasis) Not for IVD use Not for IVD use Mounting media (Histology/Cytology) Mounting media (Histology/Cytology) Histo/Cyto stains Histo/Cyto stains Mycology Controls - Inf.Imm. Mycology Controls - Inf.Imm. Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Haemoglobin determinations (Total Hb) Entamoeba histolytica HC Hardware + dedicated accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 78 of 108

GMDN Term

GMDN Code

EDMA Code

23 05 10 01 14 04 01 01 14 04 01 01 14 02 02 07 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 13 01 03 01 00 00 00 00 13 01 03 01 13 01 03 01 15 01 90 90 11 01 01 28 11 02 01 32 14 02 02 07 13 01 09 01 13 01 02 02 14 02 05 90 13 01 20 05 13 01 20 04 15 02 02 01 13 01 09 90 28 01 10 01 13 03 04 90 12 03 90 01 13 01 90 90 11 02 01 02 21 05 10 02 12 09 01 06 12 09 01 02 12 08 01 09 12 08 01 09 12 50 01 02 12 09 01 05

EDMA Term

HC Hardware + dedicated accessories + software Cells for Tissue Culture Cells for Tissue Culture Mycoplasma - Manual Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Histo/Cyto stains Not for IVD use Histo/Cyto stains Histo/Cyto stains Other Other Bacteriology Immunoassays Phospho Hexose Isomerase Uric Acid Mycoplasma - Manual Cellular enzyme determination reagents (G-6-PDH, Pyuvate Kinase) Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Other Manual Susceptibility Testing Platelet Control Haemoglobin Control Hepatitis B Surface Antigen Other Other Haematology Testing Reagents SP Hardware + accessories + software Other Antibody Detection (Immunohaematology) Alphafetoprotein Other Other Haematology Reagents Bile acids HPLC Hardware + dedicated accessories + software Cocaine + Cocaine Metabolites Amphetamine/Methamphetamine Specific (+Ecstasy) Quinidine Quinidine TDM/Drug Controls Cannabinoids

Slide stainer, immersion type 40051 Cell, animal and human, cultured 40052 Media and component, synthetic cell and tissue culture 40053 Media, Mycoplasma detection 40054 Auramine O 40055 40056 Azure C Bismarck brown Y 40057 Brilliant cresyl blue 40058 40059 Brilliant green Carmine 40060 40061 Chlorazol black E Erythrosin B 40062 Ethyl eosin 40063 Jenner stain 40064 Acid, periodic 40065 Hematoxylin, Ehrlich's 40066 Basic fuchsin 40067 Antisera, C. acnes 40070 Nad reduction (U.V.), phosphohexose isomerase 40071 Colorimetric uric acid 40084 Media and component, Mycoplasma detection 40096 Assay, erythrocytic glucose-6-phosphate dehydrogenase 40102 Assay, fetal hemoglobin 40103 Fluorescent proc. (qual.), galactose-1-phosphate uridyl transferase 40105 Calibrator for platelet counting 40111 Calibrator for hemoglobin and hematocrit measurement 40112 System for the identification of hepatitis B antigen 40113 40114 Solution, copper sulfate for specific gravity determination Centrifuge, cell-washing, automated for immuno-hematology 40115 System, test, automated blood grouping and antibody 40116 System, test, alpha-fetoprotein, RIA 40120 Reagent, immunoassay, carbonic anhydrase B and C 40121 Radioimmunoassay, conjugated sulfalithocholic (SLCG) acid, bile acid 40127 Chromatography (gas), clinical use 40137 High pressure liquid chromatography, cocaine and cocaine metabolite 40138 High pressure liquid chromatography, methamphetamine 40139 EAS chromatography, quinine 40140 High pressure liquid chromatography, quinine 40141 40142 Drug specific control material Radioimmunoassay, cannabinoid 40143

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 79 of 108

GMDN Term

GMDN Code

40144 40148 40149 40151 40153 40154 40155 40156 40157 40158 40159 40160 40163 40164 40165 40166 40167 40170 40171 40173 40174 40175 40176 40177 40179 40180 40183 40184 40188 40193 40194 40195 40197 40199 40200 40201 40202 40203 40204 40206

EDMA Code

12 50 01 02 11 02 01 34 11 02 01 34 12 08 03 06 13 02 04 02 11 02 01 14 12 70 05 02 12 08 04 02 12 08 02 09 12 08 02 07 12 08 02 01 12 08 02 90 12 09 02 01 13 07 01 05 13 07 01 05 13 07 01 05 13 07 01 05 12 09 02 15 12 09 02 15 11 02 01 32 12 05 02 05 12 08 03 09 15 04 03 04 15 05 01 06 12 08 03 90 13 01 02 02 12 08 02 07 12 08 04 02 15 01 05 03 15 01 90 14 24 09 10 01 15 01 02 03 14 01 08 02 15 04 02 04 15 01 03 03 15 04 80 06 13 05 01 01 15 01 01 03 13 05 01 01 15 05 01 04

EDMA Term

TDM/Drug Controls Lipoprotein Electrophoresis Lipoprotein Electrophoresis Netilmycin Platelet Factor 4 Glycosylated/Glycated Haemoglobin IC=12.06.01.06 HCG - Rapid Test Theophylline Primidone Phenobarbital Carbamazepine Other Central Nervous System TDM Acetaminophene (Paracetamol) Fixing reagents (Histology/Cytology) Fixing reagents (Histology/Cytology) Fixing reagents (Histology/Cytology) Fixing reagents (Histology/Cytology) Tricyclic Antidepressants (Total) Tricyclic Antidepressants (Total) Uric Acid Human Chorionic Gonadotropin Total Tobramycin HSV Antibodies - Total Toxoplasma Antibody IgM Other Antibiotics TDM Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Phenobarbital Theophylline Legionella Antibody Assays Shigella Other_MCB Hardware + dedicated accessories + software Gonococcal Antibody Assays Total Other Stains CMV Antibodies - Total Syphilis Antibody Assays Total Rotavirus Antibodies for B and T-cell subtyping Chlamydia Antibody Assays Total Antibodies for B and T-cell subtyping Toxoplasma Antibody (Total)

Procainamide control material LDL & VLDL precipitation, HDL LDL & VLDL precipitation, cholesterol via esterase-oxidase, HDL Radioimmunoassay, netilmicin (I-125) Platelet factor 4 radioimmunoassay Assay, glycosylated hemoglobin Kit, test, pregnancy, HCG, over the counter U.V. spectrometry, theophylline U.V. spectrometry, primidone U.V. spectrometry, phenobarbital U.V. spectrometry, carbamazepine U.V. spectrometry, diphenylhydantoin Colorimetry, acetaminophen Fixative, acid containing Fixative, metallic containing Fixative, formalin-containing Fixative, alcohol containing U.V. spectrometry, tricyclic antidepressant drug High pressure liquid chromatography, tricyclic antidepressant drug Acid, uric, acid reduction of ferric ion Radioreceptor assay, human chorionic gonadotropin Fluorescence polarization immunoassay, tobramycin Enzyme linked immunoabsorbent assay, Herpes simplex virus Enzyme linked immunoabsorbent assay, Toxoplasma gondii Fluorescence polarization immunoassay, amibacin Assay, Bart's, hemoglobin Fluorescence polarization immunoassay, phenobarbital Fluorescence polarization immunoassay, theophylline Reagent, antibody, Legionella, direct & indirect fluorescent Antigen, all groups, Shigella spp. Device, general purpose, microbiology, diagnostic Antiserum, coagglutination (direct) Neisseria gonorrhoeae Peroxidase anti-peroxidase immunohistochemical stain Antisera, conjugated fluorescent, cytomegalovirus Enzyme linked immunoabsorption assay, Treponema pallidum Enzyme linked immunoabsorbent assay, rotavirus Assay, T lymphocyte surface marker Enzyme linked immunoabsorbent assay, (Chlamydiae group) Assay, B lymphocyte marker Antisera, IF, Toxoplasma gondii

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 80 of 108

GMDN Term

GMDN Code

40208 40209 40211 40212 40214 40215 40216 40217 40218 40225 40226 40227 40228 40229 40230 40231 40239 40243 40246 40254 40255 40256 40257 40258 40260 40261 40269 40272 40294 40295 40296 40297 40300 40301 40310 40319 40320 40328 40332 40333

EDMA Code

12 10 01 01 15 04 04 04 14 02 05 01 15 04 03 01 15 01 01 03 15 01 01 03 12 01 90 01 21 01 10 01 12 10 90 20 29 01 10 01 12 03 90 01 12 03 90 01 15 02 01 06 15 02 02 40 14 05 02 90 23 09 10 01 15 01 14 40 15 06 01 02 12 10 01 05 15 01 01 40 15 01 10 40 14 02 03 01 12 10 01 05 12 03 01 32 12 50 01 09 15 01 02 03 00 00 00 00 11 02 01 21 13 05 01 01 13 06 01 11 16 01 03 12 08 06 01 15 04 80 05 15 01 13 40 15 06 01 90 11 02 01 90 12 03 01 37 15 01 01 12 08 06 01 12 08 06 01

EDMA Term

ANA Screening EBV Antibodies MIC Systems - Manual HSV Antigen Chlamydia Antibody Assays Total Chlamydia Antibody Assays Total a1-Acid Glycoprotein ( Orosomucoid ) CH Hardware + dedicated accessories + software Ribosomal Phosphoprotein Antibodies Other Hardware + dedicated accessories + software Alphafetoprotein Alphafetoprotein HAV Antibody IgM Hepatitis B Virus - NA Reagents Other Parasite Antigen Detection Other_HHC Hardware + dedicated accessories + software Campylobacter Detection by NA Reagents Candida albicans ds DNA - Antibodies Chlamydia Detection by NA Reagents Salmonella Detection by NA Reagents Serotyping (E.coli, Salmonella, Shigella, etc.) ds DNA - Antibodies Total Prostatic Specific Antigen Tumour Marker Standards / Calibrators Gonococcal Antibody Assays Total Not for IVD use Low Density Lipoprotein Cholesterol Antibodies for B and T-cell subtyping Interleukins (IL-1,IL-1A,IL-1B,.. - IL-15) Chromosomal Disorders Cyclosporine Total Respiratory Syncytial Virus (RSV) Listeria Detection by NA Reagents Other Mycology Immunoassays Other Substrates Prostatic Acid Phosphatase (IC) CC =>11.01.01.02 Chlamydia Cyclosporine Total Cyclosporine Total

Antinuclear antibody (enzyme-labeled), antigen, control Antibody IgM, IF, Epstein-Barr virus Culture media, antimicrobial susceptibility test Antigen, indirect hemagglutination (IHA) Herpes simplex virus Antisera, immunoperoxidase, Chlamydia spp. Antisera, fluorescent, Chlamydia spp. Alpha-1-acid-glycoprotein, antigen, antiserum, control Counter, urine particle Anti-RNP antibody, antigen and control Analyzer, chromosome, automated Kit, test, alpha-fetoprotein for testicular cancer Kit, test, alpha-fetoprotein for neural tube defect Hepatitis A test (antibody and IgM antibody) Hepatitis B test (B core, Be antigen, Be antibody, and B core IgM) Reagent, Leishmanii serological Device, general purpose, hematology DNA-reagent, Campylobacter spp. Candida spp., direct antigen, ID Anti-DNA antibody (enzyme-labeled), antigen, control DNA-reagent, Chlamydia DNA-reagent, Salmonella spp. Reagent, borrelia serological reagent Anti-DNA antibody, antigen and control Prostate-specific antigen (PSA) for management of prostate cancer Calibrator for alpha-fetoprotein in mid-pregnancy maternal serum Test reagent, Neisseria gonorrhoeae biochemical Analyzer, hydrogen gas Column, adsorption, low density, lipoprotein DNA-probe, B and T lymphocyte Assay, interleukin DNA-probe, human chromosome Cyclosporine and matabolite serum assay Respiratory syncytial virus - ELISA DNA-probe, agent, Listeria DNA-probe - Blastomyces dermatitidis Assay, serum sialic acid Kit, RIA, antigen & kit, prostatic acid phosphatase C. trachomatis (chlamydia group) High performance liquid chromatography for cyclosporine Fluroesence polorization immunoassay for cyclosporine

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 81 of 108

GMDN Term

GMDN Code

40334 40335 40336 40338 40343 40344 40345 40347 40348 40350 40354 40356 40357 40379 40381 40386 40387 40393 40403 40404 40405 40406 40408 40409 40414 40415 40417 40418 40435 40436 40437 40438 40439 40441 40442 40443 40444 40445 40446 40447

EDMA Code

12 08 06 01 12 03 90 08 12 03 01 32 11 70 02 01 15 05 10 02 15 06 01 90 15 06 01 90 14 02 05 01 14 03 06 15 01 05 01 12 09 01 08 12 09 02 15 13 01 02 02 12 10 90 20 11 02 01 03 12 01 90 90 12 07 02 90 11 02 01 21 12 01 04 21 12 08 06 03 12 01 04 21 11 02 01 04 12 10 90 06 12 04 01 08 12 03 01 32 12 03 01 32 25 01 30 01 15 03 30 04 12 13 01 05 15 03 01 07 15 03 01 04 15 03 01 04 15 03 01 04 12 03 02 02 15 01 90 09 15 04 80 09 15 04 80 09 12 13 01 02 15 02 03 04 11 03 01 10

EDMA Term

Cyclosporine Total Neuron Specific Enolase Total Prostatic Specific Antigen Urine Single Test Strips (incl. tablets) Chagas Other Mycology Immunoassays Other Mycology Immunoassays MIC Systems - Manual Susceptibility Testing (Mycology) Legionella Antigen Detection Cotinine Tricyclic Antidepressants (Total) Haemoglobin subtypes HbA2,HbC,HbF,HbS,etc.(excl. HbA1) Ribosomal Phosphoprotein Antibodies Bilirubin Other Other Plasma Proteins Other Vitamin Tests Low Density Lipoprotein Cholesterol Lipoprotein ( a ) Tacrolimus Lipoprotein ( a ) Urea/Blood Urea Nitrogen Gliadin Antibodies Thyroglobulin Total Prostatic Specific Antigen Total Prostatic Specific Antigen II Consumables HTLV I Antibody Myoglobin HIV 1 Antibody - Confirmatory HIV 1 Antibody (Total) HIV 1 Antibody (Total) HIV 1 Antibody (Total) Progesterone Receptor Assays Tetanus (Clostridium T.) Parvovirus B 19 Parvovirus B 19 Creatine Kinase - MB "Mass" (IC) CC =>11.01.01.14.00 HCV Antibody (Total) Sodium

Radioimmunoassay for cyclosporine Enzyme immunoassay for gamma-enolase Radioimmunoassay for prostate-specific antigen Strip, test isoniazid Enzyme linked immunosorbent assay, T. cruzi Enzyme linked immunosorbent assay, Coccidioides immitis Enzyme linked immunoabsorbent assay, Histoplasma capsulatum Culture media, antimycobacteria, susceptibility test Culture media, antifungal, susceptibility test Legionella, spp., ELISA Enzyme immunoassasy, nocotine and nicotine metabolite Thin layer chroomatography, tricyclic antidepressant drug Hemoglobin C (abnormal hemoglobin variant) Anti-ribosomal P antibody Bilirubin (total and unbound) in the neonate test system Enzyme linked immunosorbent assay, thrombus precursor protein System, test, vitamin D System, test, low density, lipoprotein Apolipoprotein Immunoassay for blood tacrolimus System, test, lipoprotein (A) Test, urea (breath or blood) Antibody, gliadin System, test, thyroglobulin Total, prostate specific antigen (noncomplexed & complexed) for Test, prostate specific antigen, free, (noncomplexed) to distinguish Kit, sample collection, HIV Antibody to HTLV-1, ELISA Biosensor, immunoassay, myoglobin Kit, western blot, HIV-1 Antibody, monoclonal blocking, HIV-1 Monoclonal, HIV-1 System, test, home, HIV-1 Immunohistochemistry assay, antibody, progesterone receptor Assay,enzyme linked immunosorbent,tetanus antibody test Assay, enzyme linked immunosorbent, parvovirus B19 IgG Assay, enzyme linked immunosorbent, parvovirus B19 IgM Biosensor, immunoassay, CPK or isoenzyme Assay, enzyme linked immunosorbent, hepatitis C virus System, test, sodium, enzymatic method

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 82 of 108

GMDN Term

GMDN Code

EDMA Code

11 03 01 09 12 03 01 34 11 02 01 15 12 13 01 01 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 03 01 90 40459 15 50 01 03 15 03 01 01 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 03 10 90 15 03 10 01 15 50 01 03 15 50 01 03 13 02 05 02 24 09 10 01 24 09 10 01 24 09 10 01 00 00 00 00 23 03 10 01 28 01 10 01 14 01 06 02 12 50 01 12 12 50 01 11 12 50 01 05 12 50 01 06 12 50 01 05 12 50 01 06 12 50 01 05 12 50 01 06 13 03 20 02 13 03 20 02 13 03 20 02 13 03 20 02

EDMA Term

Potassium Complexed Prostatic Specific Antigen High Densitiy Lipoprotein Cholesterol Atrial- Brain Natriuric Peptide (incl. Pro-ANP/BNP) Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Other HIV 1 Reagents 15 50 01 03 Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. HIV 1 Antigen Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Other HIV P24 Reagents HIV P24 Antigen Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Fibrinogen Degradation Products Other_MCB Hardware + dedicated accessories + software Other_MCB Hardware + dedicated accessories + software Other_MCB Hardware + dedicated accessories + software Not for IVD use BG Hardware + dedicated accessories + software SP Hardware + accessories + software Paediatric Bottles (Blood Culture -Autom.) Anaemia Related/Vitamin Controls Anaemia Related/Vitamin Standards and Calibrators Specific Protein Standards / Calibrators Specific Protein Controls Specific Protein Standards / Calibrators Specific Protein Controls Specific Protein Standards / Calibrators Specific Protein Controls Control Kits (Immunohaematology) Control Kits (Immunohaematology) Control Kits (Immunohaematology) Control Kits (Immunohaematology)

Test, system, potassium, enzymatic method 40448 Antigen (complexed), prostate specific, (CPSA) 40449 Lipoprotein, high density, HDL, OTC 40450 Test, natriuretic peptide 40452 Human immunodeficiency virus 1 antigen control 40454 40455 Human immunodeficiency virus 1 antigen calibrator Human immunodeficiency virus 1 antigen p24 confirmatory control 40456 Human immunodeficiency virus 1 antigen p24 confirmatory calibrator 40457 40458 Human immunodeficiency virus 1 antigen/antibody dissociation kit Human immunodeficiency virus 1 antigen/antibody dissociation control 40460 Human immunodeficiency virus 1 antigen/antibody dissociation Human immunodeficiency virus 1 antigen neutralization kit 40461 Human immunodeficiency virus 1 antigen neutralization control 40462 Human immunodeficiency virus 1 antigen neutralization calibrator 40463 Human immunodeficiency virus 1 antigen p24 control 40465 Human immunodeficiency virus 1 antigen p24 calibrator 40466 Human immunodeficiency virus 1 antigen p24 confirmatory kit 40467 HIV1 antigen P24 neutralization kit 40472 HIV-1 antigen p24 neutralization control 40473 HIV-1 antigen p24 neutralization calibrator 40474 Fibrin degradation product 40489 CO2 incubator 40492 Incubator, laboratory, carbon dioxide 40520 Chamber, incubator CO2 40521 Laboratory equipment, thermostat heating/cooling 40527 Laboratory equipment, view box, ultraviolet 40734 Centrifuge rotor, <specify> 41198 Culture medium, blood, paediatric, automated 41227 Vitamin D control, 25-hydroxyvitamin D3 41252 41253 Vitamin D calibrator, 25-hydroxyvitamin D3 Alpha1-antitrypsin calibrator 41254 Alpha1-antitrypsin control 41255 Alpha1-microglobulin calibrator 41258 Alpha1-microglobulin control 41259 Alpha2-macroglobulin calibrator 41260 Alpha2-macroglobulin control 41261 ABO grouping cell calibrator 41262 ABO grouping cell control 41263 41265 ABO serum calibrator ABO serum control 41266

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 83 of 108

GMDN Term

Alpha2-pregnancy-associated glycoprotein calibrator Alpha2-pregnancy-associated glycoprotein control Antinuclear antibody calibrator Antinuclear antibody control Adenovirus calibrator Adenovirus control Adenovirus kit Anti-B2-glycoprotein I antibody calibrator Anti-B2-glycoprotein I antibody control Antiganglioside total antibody calibrator Antiganglioside total antibody control Anticardiolipin antibody calibrator Anticardiolipin antibody control Anti-GD1b antibody calibrator Anti-GD1b antibody control Anti-GM1 antibody calibrator Anti-GM1 antibody control Antihistamine antibody calibrator Antihistamine antibody control Anti-Hu antibody calibrator Anti-Hu antibody control Antimyelin-associated glycoprotein calibrator Antimyelin-associated glycoprotein control Antimitochondrial antibody calibrator Antimitochondrial antibody control Antiphosphatidylserine antibody calibrator Antiphosphatidylserine antibody control Anti-Ri antibody calibrator Anti-Ri antibody control Antistreptococcal Dnase B calibrator Antistreptococcal Dnase B control Antistreptococcal hyaluronidase calibrator Antistreptococcal hyaluronidase control Antistreptokinase antibody calibrator Antistreptokinase antibody control Antihuman immunoglubulin polyvalent antiserum calibrator Antihuman immunoglobulin polyvalent antiserum control Anti-Yo blood group antibody calibrator Anti-Yo blood group antibody control B/T-cell subtyping antibody calibrator

GMDN Code

41268 41269 41270 41271 41272 41273 41274 41275 41276 41277 41278 41279 41280 41281 41282 41283 41284 41285 41286 41287 41288 41289 41290 41291 41292 41293 41294 41295 41296 41297 41298 41299 41300 41301 41302 41303 41304 41305 41306 41307

EDMA Code

12 50 01 03 12 50 01 04 12 50 01 13 12 50 01 14 15 50 01 04 15 50 01 04 15 04 80 01 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13

EDMA Term

Hormone Standards / Calibrators Hormone Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Adenovirus Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 84 of 108

GMDN Term

GMDN Code

41308 41309 41310 41311 41312 41313 41314 41315 41316 41317 41318 41319 41320 41321 41322 41326 41331 41332 41334 41335 41337 41338 41340 41341 41343 41344 41346 41347 41348 41349 41350 41351 41352 41353 41354 41355 41356 41357 41358 41359

EDMA Code

12 50 01 14 13 04 01 04 13 04 01 04 13 05 01 06 13 05 01 06 13 05 01 03 13 05 01 03 13 05 01 04 13 05 01 04 13 05 01 05 13 05 01 05 12 50 01 13 12 50 01 14 12 50 01 05 12 50 01 06 14 50 01 90 12 50 01 11 12 50 01 12 12 50 01 11 12 50 01 12 12 50 01 11 12 50 01 12 12 50 01 11 12 50 01 12 12 50 01 05 12 50 01 06 12 50 01 13 12 50 01 14 12 50 01 05 12 50 01 06 12 50 01 05 12 50 01 06 12 50 01 05 12 50 01 06 12 50 01 05 12 50 01 06 12 50 01 05 12 50 01 06 12 50 01 05 12 50 01 06

EDMA Term

Rheumatoid/Autoimmune Controls HLA Control Cells HLA Control Cells Antibodies for Lymphocyte subtyping Antibodies for Lymphocyte subtyping Antibodies for lymphoma typing(except B-&T-cell typing) Antibodies for lymphoma typing(except B-&T-cell typing) Antibodies for recognizing cell surface receptors Antibodies for recognizing cell surface receptors Antibodies for subtyping of leukemia(except B-&T-cell typing) Antibodies for subtyping of leukemia(except B-&T-cell typing) Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Specific Protein Standards / Calibrators Specific Protein Controls Other Controls Microbiology Anaemia Related/Vitamin Standards and Calibrators Anaemia Related/Vitamin Controls Anaemia Related/Vitamin Standards and Calibrators Anaemia Related/Vitamin Controls Anaemia Related/Vitamin Standards and Calibrators Anaemia Related/Vitamin Controls Anaemia Related/Vitamin Standards and Calibrators Anaemia Related/Vitamin Controls Specific Protein Standards / Calibrators Specific Protein Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Specific Protein Standards / Calibrators Specific Protein Controls Specific Protein Standards / Calibrators Specific Protein Controls Specific Protein Standards / Calibrators Specific Protein Controls Specific Protein Standards / Calibrators Specific Protein Controls Specific Protein Standards / Calibrators Specific Protein Controls Specific Protein Standards / Calibrators Specific Protein Controls

B/T-cell subtyping antibody control Human leukocyte antigen class II determinant antibody calibrator Human leukocyte antigen class II determinant antibody control Lymphocyte subtyping antibody calibrator Lymphocyte subtyping antibody control Lymphoma subtyping antibody calibrator Lymphoma subtyping antibody control Cell surface receptor recognizing antibody calibrator Cell surface receptor recognizing antibody control Leukaemia subtyping antibody calibrator Leukaemia subtyping antibody control Anticytoplasmic antibody calibrator Anticytoplasmic antibody control Ceruloplasmin calibrator Ceruloplasmin control Cryptosporidium calibrator Vitamin B6 calibrator Vitamin B6 control Vitamin B2 calibrator Vitamin B2 control Vitamin B12 calibrator Vitamin B12 control Vitamin B1 calibrator Vitamin B1 control Transferrin calibrator Transferrin control Extractable nuclear antigen calibrator Extractable nuclear antigen control Immunoglobulin E monotest/monoresult multiantigen calibrator Immunoglobulin E monotest/monoresult multiantigen control Immunoglobulin E monotest/pluriresult multiantigen calibrator Immunoglobulin E monotest/pluriresult multiantigen control Immunoglobulin G calibrator Immunoglobulin G control Immunoglobulin G subclass calibrator Immunoglobulin G subclass control Immunoglobulin M calibrator Immunoglobulin M control Immunoglobulin M subclass calibrator Immunoglobulin M subclass control

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 85 of 108

GMDN Term

Immunohistologic calibrator Immunohistologic control Insulin-like growth factor binding protein 3 calibrator Insulin-like growth factor binding protein 3 control Insulin-like growth factor II calibrator Insulin-like growth factor II control Insulin antibody calibrator Insulin antibody control Interferon a/B/y calibrator Interferon a/B/y control Interleukin IL-1a/IL1b/IL1RA/IL2r/IL6r calibrator Interleukin IL-1a/IL1b/IL1RA/IL2r/IL6r control Interleukin IL-1/IL-12 calibrator Interleukin IL-1/IL-12 control Plasma protein kit Plasmodium falciparum calibrator Plasmodium falciparum control Pneumocystis carinii calibrator Pneumocystis carinii control Platelet calibrator Polyspecific antihuman serum calibrator Polyspecific antihuman serum control Proteinase 3-antineutrophil cytoplasmic autoantibody calibrator Proteinase 3-antineutrophil cytoplasmic autoantibody control Prealbumin/transthyretin calibrator Prealbumin/transthyretin control Jo-1 antibody calibrator Jo-1 antibody control Erythropoietin calibrator Erythropoietin control Monoethylglycinexylidide calibrator Monoethylglycinexylidide control Melatonine calibrator Melatonine control Myosin light chain calibrator Haemoglobin calibrator Haemoglobin control Haemoglobin subtype calibrator Haemoglobin subtype control Haemostasis buffer calibrator

GMDN Code

41360 41361 41362 41363 41364 41365 41367 41368 41369 41370 41371 41372 41373 41374 41375 41376 41377 41378 41379 41380 41383 41384 41385 41386 41387 41388 41389 41390 41391 41392 41393 41394 41395 41396 41398 41399 41400 41401 41402 41403

EDMA Code

13 07 01 11 13 07 01 11 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 13 06 01 01 13 06 01 01 13 06 01 12 13 06 01 12 13 06 01 11 13 06 01 11 12 01 90 90 14 50 01 90 14 50 01 90 14 50 01 90 14 50 01 90 13 01 20 05 13 03 20 02 13 03 20 02 12 50 01 13 12 50 01 14 12 50 01 05 12 50 01 06 12 50 01 13 12 50 01 14 12 50 01 11 12 50 01 12 12 50 01 80 12 50 01 90 12 50 01 15 12 50 01 16 12 50 01 07 13 01 20 04 13 01 20 04 13 01 20 04 13 01 20 04 13 02 80 90

EDMA Term

Immunohistology kits Immunohistology kits Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Interferons (a,b,y) Interferons (a,b,y) Interleukins Receptors(IL-2R,IL6R ...) Interleukins Receptors(IL-2R,IL6R ...) Interleukins (IL-1,IL-1A,IL-1B,.. - IL-15) Interleukins (IL-1,IL-1A,IL-1B,.. - IL-15) Other Other Plasma Proteins Other Controls Microbiology Other Controls Microbiology Other Controls Microbiology Other Controls Microbiology Platelet Control Control Kits (Immunohaematology) Control Kits (Immunohaematology) Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Specific Protein Standards / Calibrators Specific Protein Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Anaemia Related/Vitamin Standards and Calibrators Anaemia Related/Vitamin Controls Other Standards / Calibrators Immunochemistry Other Controls Immunochemistry Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Cardiac Marker Standards / Calibrators Haemoglobin Control Haemoglobin Control Haemoglobin Control Haemoglobin Control Other Auxiliary Reagents (Haemostasis)

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 86 of 108

GMDN Term

Haemostasis buffer control Haptoglobin calibrator Haptoglobin control Human papillomavirus calibrator Human papillomavirus control Lactoferrin calibrator Lactoferrin control Lymphocyte stabilizing media calibrator Lymphocyte stabilizing media control Lymphocyte stabilizing media kit Leukotriene stimulation test calibrator Leukotriene stimulation test control Leukotriene stimulation test kit Lipoprotein A calibrator Lipoprotein A control Lipoprotein A kit Liver-kidney microsome 1/related protein antibody calibrator Liver-kidney microsome 1/related protein antibody control Lymphocyte separation media calibrator Lymphocyte separation media control Lymphocyte separation media kit Glandular fever calibrator Glandular fever control Kappa/lambda chain calibrator Kappa/lambda chain control Prepared media in plates, bacteriology Tube, centrifuge Adaptor, centrifuge tube Alkaline phosphatase isoenzyme calibrator Dispenser, liquid, laboratory, electronic Alkaline phosphatase isoenzyme control 5-aminolevulinate dehydratase calibrator 5-aminolevulinate dehydratase control Antiphospholipid antibody control Antiphospholipid antibody calibrator Activated protein C resistance control Activated protein C resistance calibrator Aspartate aminotransferase total activity control Aspartate aminotransferase total activity calibrator Coagulation factor II control

GMDN Code

41404 41405 41406 41407 41408 41409 41410 41411 41412 41413 41414 41415 41416 41417 41418 41419 41420 41421 41425 41426 41427 41428 41429 41430 41431 41493 41509 41594 41657 41663 41686 41689 41690 41691 41692 41694 41695 41697 41698 41699

EDMA Code

13 02 80 90 12 50 01 05 12 50 01 06 15 50 01 04 15 50 01 04 12 50 01 05 12 50 01 06 13 04 01 07 13 04 01 07 13 04 01 07 12 50 01 05 12 50 01 06 12 02 01 07 12 50 01 05 12 50 01 06 12 01 04 21 12 50 01 13 12 50 01 14 13 04 01 06 13 04 01 06 13 04 01 06 13 01 20 90 13 01 20 90 12 50 01 05 12 50 01 06 14 01 04 28 01 10 01 28 01 10 01 11 50 02 01 28 01 10 01 11 50 02 01 12 50 01 01 12 50 01 02 13 02 50 90 13 02 50 90 13 02 50 90 13 02 50 90 11 50 02 01 11 50 03 02 13 02 50 90

EDMA Term

Other Auxiliary Reagents (Haemostasis) Specific Protein Standards / Calibrators Specific Protein Controls Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Specific Protein Standards / Calibrators Specific Protein Controls Lymphocyte stabilizing media Lymphocyte stabilizing media Lymphocyte stabilizing media Specific Protein Standards / Calibrators Specific Protein Controls Leukotriene Stimulation test Specific Protein Standards / Calibrators Specific Protein Controls Lipoprotein ( a ) Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Lymphocyte separation media Lymphocyte separation media Lymphocyte separation media Other Haematology Controls Other Haematology Controls Specific Protein Standards / Calibrators Specific Protein Controls Prepared Media in Plates (Bacteriology) SP Hardware + accessories + software SP Hardware + accessories + software Enzyme Control Sera SP Hardware + accessories + software Enzyme Control Sera TDM/Drug Standards / Calibrators TDM/Drug Controls Other Haemostasis Controls Other Haemostasis Controls Other Haemostasis Controls Other Haemostasis Controls Enzyme Control Sera Calibrators Single Component (CC) Other Haemostasis Controls

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 87 of 108

GMDN Term

GMDN Code

EDMA Code

13 02 50 90 13 01 03 01 13 02 50 90 13 01 03 90 13 01 03 90 13 02 50 90 12 50 01 02 12 50 01 01 12 50 01 04 12 50 01 03 13 02 50 01 13 02 50 02 11 50 02 01 11 50 03 02 11 50 03 02 11 50 02 02 12 50 01 01 12 50 01 02 12 50 01 08 12 50 01 07 12 50 01 03 12 50 01 04 11 50 03 02 11 50 02 90 12 50 01 01 12 50 01 02 13 02 50 01 13 02 50 02 12 50 01 01 12 50 01 02 12 50 01 03 12 50 01 04 12 50 01 01 12 50 01 02 13 01 03 01 12 50 01 05 12 50 01 06 12 50 01 01 12 50 01 02 13 02 04 01

EDMA Term

Other Haemostasis Controls Histo/Cyto stains Other Haemostasis Controls Other Haematology stains Other Haematology stains Other Haemostasis Controls TDM/Drug Controls TDM/Drug Standards / Calibrators Hormone Controls Hormone Standards / Calibrators Calibration Plasmas Control Plasmas Enzyme Control Sera Calibrators Single Component (CC) Calibrators Single Component (CC) Lipid Control Sera TDM/Drug Standards / Calibrators TDM/Drug Controls Cardiac Marker Controls Cardiac Marker Standards / Calibrators Hormone Standards / Calibrators Hormone Controls Calibrators Single Component (CC) Other Specific Control Sera (CC) TDM/Drug Standards / Calibrators TDM/Drug Controls Calibration Plasmas Control Plasmas TDM/Drug Standards / Calibrators TDM/Drug Controls Hormone Standards / Calibrators Hormone Controls TDM/Drug Standards / Calibrators TDM/Drug Controls Histo/Cyto stains Specific Protein Standards / Calibrators Specific Protein Controls TDM/Drug Standards / Calibrators TDM/Drug Controls Aggregation Factors

Coagulation factor II calibrator 41700 Stain, light microscopy, haematology 41701 Coagulation factor high molecular weight (HMW) kininogen control 41702 Fitzgerald control 41703 Fitzgerald calibrator 41704 Coagulation factor high molecular weight (HMW) kininogen calibrator 41705 Vanilmandelic acid control 41708 Vanilmandelic acid calibrator 41709 41711 Thyroglobulin control Thyroglobulin calibrator 41712 41724 Thrombin-antithrombin III-complex calibrator Thrombin-antithrombin III-complex control 41725 Lactate dehydrogenase total activity control 41726 Lactate dehydrogenase total activity calibrator 41727 Low density lipoprotein calibrator 41728 Low density lipoprotein control 41729 Lysergic acid diethylamide calibrator 41730 Lysergic acid diethylamide control 41731 Myoglobin control 41732 Myoglobin calibrator 41733 Neonatal thyroid stimulating hormone calibrator 41734 Neonatal thyroid stimulating hormone control 41735 Non-esterified fatty acid calibrator 41737 Non-esterified fatty acid control 41738 Nortriptyline calibrator 41740 Nortriptyline control 41741 Prothrombin fragment 1+2 calibrator 41742 Prothrombin fragment 1+2 control 41743 Protoporphyrin calibrator 41744 41745 Protoporphyrin control Reverse triiodothyronine calibrator 41746 Reverse triiodothyronine control 41747 Salicylate calibrator 41748 Salicylate control 41749 Stain, light microscopy, microbiology 41750 Serotonin calibrator 41751 Serotonin control 41752 Sisomycin calibrator 41753 41754 Sisomycin control Platelet kit 41755

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 88 of 108

GMDN Term

Influenza/parainfluenza calibrator Influenza/parainfluenza control Varicella-zoster kit Cytomegalovirus nucleic acid calibrator Cytomegalovirus nucleic acid control Immunoglobulin A calibrator Immunoglobulin A control Myosin light chain control Immunoglobulin A subclass calibrator Immunoglobulin A subclass control Immunoglobulin D calibrator Immunoglobulin D control Immunoglobulin D subclass calibrator Immunoglobulin D subclass control Troponin calibrator Troponin control Androstenedione calibrator Androstenedione control Amanitin calibrator Amanitin control Brucella calibrator Brucella control Yersinia calibrator Yersinia control Stain, light microscopy, cytology/histology Bombesin calibrator Bombesin control Adrenocorticotropic hormone calibrator Adrenocorticotropic hormone control Entamoeba calibrator Entamoeba control Anti-cancer associated retinopathy calibrator Anti-cancer associated retinopathy control Blood group antibody 2 cell screening calibrator Blood group antibody 2 cell screening control Antibody 3 cell screening calibrator Antibody 3 cell screening control Antibody identification cell panel calibrator Antibody identification cell panel control Apolipoprotein A-I calibrator

GMDN Code

41757 41758 41759 41761 41764 41765 41766 41767 41768 41769 41770 41771 41772 41773 41775 41776 41779 41780 41782 41783 41784 41785 41788 41789 41792 41793 41794 41795 41796 41797 41798 41799 41800 41802 41803 41804 41805 41806 41807 41808

EDMA Code

15 50 01 04 15 50 01 04 15 04 80 10 15 50 01 04 15 50 01 04 12 50 01 05 12 50 01 06 12 50 01 08 12 50 01 05 12 50 01 06 12 50 01 05 12 50 01 06 12 50 01 05 12 50 01 06 12 50 01 07 12 50 01 08 12 50 01 03 12 50 01 04 12 50 01 80 12 50 01 90 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 13 01 03 01 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 15 50 01 05 15 50 01 05 12 50 01 13 12 50 01 14 13 03 20 02 13 03 20 02 13 03 20 02 13 03 20 02 13 03 20 02 13 03 20 02 12 50 01 05

EDMA Term

Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Varicella Zoster Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Specific Protein Standards / Calibrators Specific Protein Controls Cardiac Marker Controls Specific Protein Standards / Calibrators Specific Protein Controls Specific Protein Standards / Calibrators Specific Protein Controls Specific Protein Standards / Calibrators Specific Protein Controls Cardiac Marker Standards / Calibrators Cardiac Marker Controls Hormone Standards / Calibrators Hormone Controls Other Standards / Calibrators Immunochemistry Other Controls Immunochemistry Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Histo/Cyto stains Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Parasitology Controls - Inf.Imm. Parasitology Controls - Inf.Imm. Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Control Kits (Immunohaematology) Control Kits (Immunohaematology) Control Kits (Immunohaematology) Control Kits (Immunohaematology) Control Kits (Immunohaematology) Control Kits (Immunohaematology) Specific Protein Standards / Calibrators

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 89 of 108

GMDN Term

Apolipoprotein A-I control Apolipoprotein A-II calibrator Apolipoprotein A-II control Apolipoprotein B calibrator Apolipoprotein B control Apolipoprotein E genotyping calibrator Apolipoprotein E genotyping control Asialo-GM1 calibrator Asialo-GM1 control Glucose calibrator Glucose control Assayed multicomponent serum calibrator, abnormal Assayed multicomponent serum control, abnormal Assayed multicomponent serum calibrator, normal Assayed multicomponent serum control, normal Atrial natriuretic peptide calibrator Atrial natriuretic peptide control Beta-endorphin calibrator Beta-endorphin control Bilirubin calibrator Malachite green G Biochemical identification calibrator, anaerobe, automated Biochemical identification control, anaerobe, automated control C-peptide calibrator C-peptide control C-reactive protein calibrator C-reactive protein control Calcitonin calibrator Calcitonin control Calcium calibrator Calcium control Cellular enzyme determination calibrator Cellular enzyme determination control CENP-antibody calibrator CENP-antibody control Chromosome culture calibrator Chromosome culture control Circulating immune complex calibrator Circulating immune complex control Citrate calibrator

GMDN Code

41809 41810 41811 41812 41813 41814 41815 41816 41817 41818 41819 41820 41821 41822 41823 41824 41825 41827 41828 41830 41832 41833 41834 41836 41837 41838 41839 41840 41841 41842 41843 41846 41847 41848 41849 41850 41851 41852 41853 41854

EDMA Code

12 50 01 06 12 50 01 05 12 50 01 06 12 50 01 05 12 50 01 06 12 50 01 05 12 50 01 06 12 50 01 13 12 50 01 14 11 50 03 02 11 50 02 05 11 50 01 01 11 50 01 01 11 50 01 01 11 50 01 01 12 50 01 07 12 50 01 08 12 50 01 15 12 50 01 16 11 50 03 02 14 01 08 02 14 50 01 90 14 50 01 90 12 50 01 15 12 50 01 16 12 50 01 13 12 50 01 14 12 50 01 15 12 50 01 16 11 50 03 02 11 50 02 04 13 01 20 90 13 01 20 90 12 50 01 13 12 50 01 14 13 07 01 01 13 07 01 01 12 50 01 13 12 50 01 14 14 50 01 90

EDMA Term

Specific Protein Controls Specific Protein Standards / Calibrators Specific Protein Controls Specific Protein Standards / Calibrators Specific Protein Controls Specific Protein Standards / Calibrators Specific Protein Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Calibrators Single Component (CC) Diabetes Controls Assayed Multicomponent Sera (CC) Assayed Multicomponent Sera (CC) Assayed Multicomponent Sera (CC) Assayed Multicomponent Sera (CC) Cardiac Marker Standards / Calibrators Cardiac Marker Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Calibrators Single Component (CC) Other Stains Other Controls Microbiology Other Controls Microbiology Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Calibrators Single Component (CC) Electrolyte Controls Other Haematology Controls Other Haematology Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Chromosome Culture Kits / reagents Chromosome Culture Kits / reagents Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Other Controls Microbiology

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 90 of 108

GMDN Term

Citrate control Collagen type I C-terminal propeptide calibrator Collagen type I C-terminal propeptide control Collagen type III C-terminal propeptide calibrator Collagen type III C-terminal propeptide control Complement component C3b activation control Reptilase kit Batroxbin time kit Thrombin time calibrator Thrombin time control Complement for HLA testing calibrator Complement for HLA testing control Coxiella calibrator Coxiella control Cross-linked C-telopeptide calibrator Cross-linked C-telopeptide control Cross-linked N-telopeptide calibrator Cross-linked N-telopeptide control Cryptosporidium control Cyclic adenosine monophosphate calibrator Cyclic adenosine monophosphate control Dehydroepiandrosterone calibrator Dehydroepiandrosterone control Deoxypyridinoline calibrator Deoxypyridinoline control Distoma calibrator Distoma control Deoxyribonucleic acid in situ hybridization calibrator Deoxyribonucleic acid in situ hybridization control Anti-deoxyribonucleic acid antibody control Echinococcus calibrator Echinococcus control Enterovirus calibrator Enterovirus control Fatty acid binding protein (FABP) calibrator Fatty acid binding protein (FABP) control Ferritin calibrator Ferritin control Fibronectin calibrator Fibronectin control

GMDN Code

41855 41856 41857 41858 41859 41866 41867 41868 41869 41870 41871 41872 41879 41880 41883 41884 41885 41886 41887 41888 41889 41896 41897 41898 41899 41903 41904 41905 41906 41907 41908 41909 41923 41924 41925 41926 41927 41928 41929 41930

EDMA Code

14 50 01 90 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 12 50 01 06 13 02 01 03 13 02 01 03 13 02 50 01 13 02 50 02 13 04 01 04 13 04 01 04 15 50 01 01 15 50 01 01 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 14 50 01 90 12 50 01 15 12 50 01 16 12 50 01 03 12 50 01 04 12 50 01 15 12 50 01 16 15 50 01 05 15 50 01 05 13 07 01 03 13 07 01 03 12 50 01 14 15 50 01 05 15 50 01 05 15 50 01 04 15 50 01 04 12 50 01 07 12 50 01 08 12 50 01 11 12 50 01 12 12 50 01 05 12 50 01 06

EDMA Term

Other Controls Microbiology Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Specific Protein Controls Thrombin Time / Reptilase / Batroxobin Time Thrombin Time / Reptilase / Batroxobin Time Calibration Plasmas Control Plasmas HLA Control Cells HLA Control Cells Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Other Controls Microbiology Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Hormone Standards / Calibrators Hormone Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Parasitology Controls - Inf.Imm. Parasitology Controls - Inf.Imm. DNA in situ Hybridisation reagents DNA in situ Hybridisation reagents Rheumatoid/Autoimmune Controls Parasitology Controls - Inf.Imm. Parasitology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Cardiac Marker Standards / Calibrators Cardiac Marker Controls Anaemia Related/Vitamin Standards and Calibrators Anaemia Related/Vitamin Controls Specific Protein Standards / Calibrators Specific Protein Controls

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 91 of 108

GMDN Term

GMDN Code

41931 41932 41933 41934 41935 41936 41940 41941 41942 41943 41944 41945 41946 41947 41948 41949 41950 41951 41952 41953 41954 41955 41957 41958 41959 41960 41961 41962 41964 41965 41966 41967 41968 41969 41970 41971 41972 41973 41974 41975

EDMA Code

12 50 01 11 12 50 01 12 12 50 01 15 12 50 01 16 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 15 12 50 01 16 12 50 01 07 12 50 01 08 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 12 50 01 13 12 50 01 14 13 07 01 05 13 01 01 01 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02

EDMA Term

Anaemia Related/Vitamin Standards and Calibrators Anaemia Related/Vitamin Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Cardiac Marker Standards / Calibrators Cardiac Marker Controls Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Fixing reagents (Histology/Cytology) CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm.

Folate calibrator Folate control Glutamic acid decarboxylase II antibody/islet cell antibody calibrator Glutamic acid decarboxylase II antibody/islet cell antibody control GalNAc calibrator GalNAc control Gliadin antibody calibrator Gliadin antibody control Glucagon calibrator Glucagon control Glycogen phosphorylase BB calibrator Glycogen phosphorylase BB control Gonococcus total antibody calibrator Gonococcus total antibody control Gonococcus antigen calibrator Gonococcus antigen control Gonococcus nucleic acid calibrator Gonococcus nucleic acid control Goodpasture antibody calibrator Goodpasture antibody control Fixative, <specify> Blood diluting fluid Hepatitis A virus immunoglobulin G calibrator Hepatitis A virus immunoglobulin G control Hepatitis A virus immunoglobulin M calibrator Hepatitis A virus immunoglobulin M control Hepatitis A virus total antibody calibrator Hepatitis A virus total antibody control Hepatitis A virus antigen confirmatory calibrator Hepatitis A virus antigen confirmatory control Hepatitis C virus antibody confirmatory calibrator Hepatitis C virus antibody confirmatory control Hepatitis C virus immunoglobulin G calibrator Hepatitis C virus immunoglobulin G control Hepatitis C virus immunoglobulin M calibrator Hepatitis C virus immunoglobulin M control Hepatitis C virus total antibody calibrator Hepatitis C virus total antibody control Hepatitis C virus antigen calibrator Hepatitis C virus antigen control

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 92 of 108

GMDN Term

Hepatitis C virus nucleic acid calibrator Hepatitis C virus nucleic acid control Hepatitis B virus core immunoglobulin M calibrator Hepatitis B virus core immunoglobulin M control Hepatitis B virus core total antibody calibrator Hepatitis B virus core total antibody control Hepatitis B virus core antigen calibrator Hepatitis B virus core antigen control Hepatitis B virus core antigen confirmatory calibrator Hepatitis B virus core antigen confirmatory control Hepatitis B virus core immunoglobulin G calibrator Hepatitis B virus core immunoglobulin G control Hepatitis B virus core nucleic acid calibrator Hepatitis B virus core nucleic acid control Hepatitis B virus surface immunoglobulin G calibrator Hepatitis B virus surface immunoglobulin G control Hepatitis B virus surface immunoglobulin M calibrator Hepatitis B virus surface immunoglobulin M control Hepatitis B virus surface total antibody calibrator Hepatitis B virus surface total antibody control Hepatitis B virus surface antigen calibrator Hepatitis B virus surface antigen control Hepatitis B virus e antibody immunoglobulin G calibrator Hepatitis B virus e antibody immunoglobulin G control Hepatitis B virus e antibody immunoglobulin M calibrator Hepatitis B virus e antibody immunoglobulin M control Hepatitis B virus e antigen total antibody calibrator Hepatitis B virus e antigen total antibody control Hepatitis B virus e antigen calibrator Hepatitis B virus e antigen control Hepatitis B virus e antigen nucleic acid calibrator Hepatitis B virus e antigen nucleic acid control Hepatitis D virus immunoglobulin G calibrator Hepatitis D virus immunoglobulin G control Hepatitis D virus total antibody calibrator Hepatitis D virus total antibody control Hepatitis D virus antigen calibrator Hepatitis D virus antigen control Hepatitis D virus nucleic acid calibrator Hepatitis D virus nucleic acid control

GMDN Code

41979 41980 41981 41982 41983 41984 41985 41986 41987 41988 41989 41990 41991 41992 41993 41994 41995 41996 41997 41998 41999 42000 42001 42002 42003 42004 42005 42006 42007 42008 42009 42010 42011 42012 42013 42014 42015 42016 42017 42018

EDMA Code

15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02

EDMA Term

Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm.

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 93 of 108

GMDN Term

Hepatitis E virus immunoglobulin G calibrator Hepatitis E virus immunoglobulin G control Hepatitis E virus immunoglobulin M calibrator Hepatitis E virus immunoglobulin M control Hepatitis E virus total antibody calibrator Hepatitis E virus total antibody control Hepatitis E virus antigen calibrator Hepatitis E virus antigen control Hepatitis E virus nucleic acid calibrator Hepatitis E virus nucleic acid control Hepatitis G virus immunoglobulin G calibrator Hepatitis G virus immunoglobulin G control Hepatitis G virus immunoglobulin M calibrator Hepatitis G virus immunoglobulin M control Hepatitis G virus total antibody calibrator Hepatitis G virus total antibody control Hepatitis G virus antigen calibrator Hepatitis G virus antigen control Hepatitis G virus nucleic acid calibrator Hepatitis G virus nucleic acid control Vitamin D calibrator, cholecalciferol Vitamin D control, cholecalciferol Vasopressin calibrator Vasopressin control Vasointestinal peptide calibrator Vasointestinal peptide control Uro/coproporphyrin calibrator Uro/coproporphyrin control Urine sediment test calibrator Urine sediment test control U1-small nuclear ribonucleoprotein antibody calibrator U1-small nuclear ribonucleoprotein antibody control Tumour necrosis factor calibrator Tumour necrosis factor control Thyroid stimulating hormone receptor antibody calibrator Thyroid stimulating hormone receptor antibody control Neonatal trypsin calibrator Neonatal trypsin control Transcobalamin S calibrator Transcobalamin S control

GMDN Code

42020 42021 42022 42023 42024 42025 42026 42027 42028 42029 42030 42031 42032 42033 42034 42035 42036 42037 42040 42041 42052 42053 42055 42056 42058 42059 42061 42062 42064 42065 42073 42074 42076 42077 42079 42080 42082 42083 42085 42086

EDMA Code

15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 15 50 01 02 12 50 01 11 12 50 01 12 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 11 50 03 02 11 50 02 90 11 50 90 02 11 50 90 02 12 50 01 13 12 50 01 14 13 06 01 04 13 06 01 04 12 50 01 13 12 50 01 14 12 50 01 05 12 50 01 06 12 50 01 05 12 50 01 06

EDMA Term

Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Hepatitis Virus Controls - Inf.Imm. Anaemia Related/Vitamin Standards and Calibrators Anaemia Related/Vitamin Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Calibrators Single Component (CC) Other Specific Control Sera (CC) Urine Control Urine Control Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Tumour Necrosis Factors (TNFa,TNFb) Tumour Necrosis Factors (TNFa,TNFb) Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Specific Protein Standards / Calibrators Specific Protein Controls Specific Protein Standards / Calibrators Specific Protein Controls

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 94 of 108

GMDN Term

GMDN Code

42087 42088 42089 42090 42091 42092 42093 42094 42095 42096 42097 42098 42099 42100 42101 42102 42103 42104 42105 42106 42107 42108 42109 42110 42117 42118 42119 42120 42121 42122 42123 42124 42125 42126 42127 42128 42129 42130 42131 42132

EDMA Code

12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 05 12 50 01 06 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 15 50 01 03 13 04 01 04 13 04 01 04 13 04 01 04 13 04 01 04 13 04 01 04 13 04 01 04 13 04 01 04 13 04 01 04 15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 04

EDMA Term

Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Specific Protein Standards / Calibrators Specific Protein Controls Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. Retrovirus Controls - Inf.Imm. HLA Control Cells HLA Control Cells HLA Control Cells HLA Control Cells HLA Control Cells HLA Control Cells HLA Control Cells HLA Control Cells Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm.

Histone calibrator Histone control Human anti-mouse antibody calibrator Human anti-mouse antibody control Insulin calibrator Insulin control Human T-cell leukaemia virus I antibody calibrator Human T-cell leukaemia virus I antibody control Human T-cell leukaemia virus I antigen calibrator Human T-cell leukaemia virus I antigen control Human T-cell leukaemia virus I nucleic acid calibrator Human T-cell leukaemia virus I nucleic acid control Human T-cell leukaemia virus II antibody calibrator Human T-cell leukaemia virus II antibody control Human T-cell leukaemia virus II antigen calibrator Human T-cell leukaemia virus II antigen control Human T-cell leukaemia virus II nucleic acid calibrator Human T-cell leukaemia virus II nucleic acid control Human T-cell leukaemia virus multiple antigen calibrator Human T-cell leukaemia virus multiple antigen control Human T-cell leukaemia virus multiple antibody calibrator Human T-cell leukaemia virus multiple antibody control Human T-cell leukaemia virus multiple antigen nucleic acid calibrator Human T-cell leukaemia virus multiple antigen nucleic acid control Human leukocyte antigen antibody screening calibrator Human leukocyte antigen antibody screening control Human leukocyte antigen typing calibrator Human leukocyte antigen typing control Human leukocyte antigen control cells calibrator Human leukocyte antigen control cells control Human leukocyte antigen nucleic acid calibrator Human leukocyte antigen nucleic acid control Herpes simplex virus total antibody calibrator Herpes simplex virus total antibody control Herpes simplex virus calibrator Herpes simplex virus control Herpes simplex virus immunoglobulin G calibrator Herpes simplex virus immunoglobulin G control Herpes simplex virus immunoglobulin M calibrator Herpes simplex virus immunoglobulin M control

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 95 of 108

GMDN Term

Herpes simplex virus nucleic acid calibrator Herpes simplex virus nucleic acid control Rubella virus nucleic acid calibrator Rubella virus nucleic acid control Rubella virus total antibody calibrator Rubella virus total antibody control Rubella virus immunoglobulin G calibrator Rubella virus immunoglobulin G control Rubella virus immunoglobulin M calibrator Rubella virus immunoglobulin M control Rotavirus calibrator Rotavirus control Leishmania calibrator Leishmania control Borrelia total antibody calibrator Borrelia total antibody control Borrelia antigen calibrator Borrelia antigen control Borrelia nucleic acid calibrator Borrelia nucleic acid control Legionella antibody calibrator Legionella antibody control Legionella antigen calibrator Legionella antigen control Legionella nucleic acid calibrator Legionella nucleic acid control Leptospira calibrator Leptospira control Toxoplasma immunoglobulin M calibrator Toxoplasma immunoglobulin M control Toxoplasma immunoglobulin G calibrator Toxoplasma immunoglobulin G control Toxoplasma total antibody calibrator Toxoplasma total antibody control Schistosoma calibrator Schistosoma control Salmonella antibody calibrator Salmonella antibody control Salmonella antigen calibrator Salmonella antigen control

GMDN Code

42133 42134 42135 42136 42137 42138 42139 42140 42141 42142 42143 42144 42145 42146 42148 42149 42150 42151 42152 42153 42154 42155 42156 42157 42158 42159 42160 42161 42163 42164 42166 42167 42169 42170 42171 42172 42173 42174 42175 42176

EDMA Code

15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 04 15 50 01 05 15 50 01 05 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 05 15 50 01 05 15 50 01 05 15 50 01 05 15 50 01 05 15 50 01 05 15 50 01 05 15 50 01 05 15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01

EDMA Term

Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Parasitology Controls - Inf.Imm. Parasitology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Parasitology Controls - Inf.Imm. Parasitology Controls - Inf.Imm. Parasitology Controls - Inf.Imm. Parasitology Controls - Inf.Imm. Parasitology Controls - Inf.Imm. Parasitology Controls - Inf.Imm. Parasitology Controls - Inf.Imm. Parasitology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm.

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 96 of 108

GMDN Term

Salmonella nucleic acid calibrator Salmonella nucleic acid control Rickettsia calibrator Rickettsia control Sex hormone binding globulin calibrator Sex hormone binding globulin control Hydroxyproline calibrator Hydroxyproline control Osteocalcine calibrator Osteocalcine control Pyridinoline calibrator Pyridinoline control Human growth hormone calibrator Human growth hormone control Insulin-like growth factor binding protein 1 calibrator Insulin-like growth factor binding protein 1 control Insulin-like growth factor I, somatomedin C calibrator Insulin-like growth factor I, somatomedin C control Neopterine calibrator Neopterine control Prostaglandin calibrator Prostaglandin control Pepsinogen calibrator Pepsinogen control Parathyroid hormone intact calibrator Parathyroid hormone intact control Parathyroid hormone-related peptide calibrator Parathyroid hormone-related peptide control Parathyroid hormone fragment calibrator Parathyroid hormone fragment control Polymyositis-scleroderma antibody calibrator Polymyositis-scleroderma antibody control Retinol binding protein calibrator Retinol binding protein control Parietal cell antibody calibrator Parietal cell antibody control Sperm antibody calibrator Sperm antibody control Systemic lupus erythematosis calibrator Systemic lupus erythematosis control

GMDN Code

42177 42178 42179 42180 42181 42182 42184 42185 42187 42188 42189 42190 42191 42192 42193 42194 42196 42197 42198 42199 42200 42201 42202 42203 42207 42208 42209 42210 42211 42212 42213 42214 42217 42218 42219 42220 42221 42222 42224 42225

EDMA Code

15 50 01 01 15 50 01 01 15 50 01 01 15 50 01 01 12 50 01 03 12 50 01 04 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 12 50 01 15 12 50 01 16 12 50 01 13 12 50 01 14 12 50 01 05 12 50 01 06 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14 12 50 01 13 12 50 01 14

EDMA Term

Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Bacteriology Controls - Inf.Imm. Hormone Standards / Calibrators Hormone Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Specific Protein Standards / Calibrators Specific Protein Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 97 of 108

GMDN Term

GMDN Code

42226 42227 42228 42229 42230 42231 42232 42233 42234 42235 42236 42242 42243 42247 42248 42249 42250 42358 42362 42363 42364 42367 42370 42371 42429 42437 42460 42461 42544 42572 42621 42649 42669 42718 42753 42755 42761 42762 42763 42764

EDMA Code

12 50 01 13 12 50 01 14 12 50 01 15 12 50 01 16 12 50 01 13 12 50 01 14 13 01 20 06 13 03 20 02 13 03 20 02 13 03 20 02 13 03 20 02 14 50 01 14 50 01 15 50 01 04 15 50 01 04 12 50 01 13 12 50 01 14 24 09 10 01 21 01 10 01 24 09 10 01 21 01 10 01 21 02 10 01 00 00 00 00 21 02 10 01 24 09 10 01 00 00 00 00 28 01 10 01 28 01 10 01 11 04 03 90 00 00 00 00 11 02 01 27 11 70 03 01 12 10 01 11 15 04 80 90 23 09 10 01 23 03 10 01 28 01 10 01 28 01 10 01 28 01 10 01 28 01 10 01

EDMA Term

Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Individual and Specified Hormones Calibrators Individual and Specified Hormones Controls Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Reticulocyte Control Control Kits (Immunohaematology) Control Kits (Immunohaematology) Control Kits (Immunohaematology) Control Kits (Immunohaematology) Controls/Standards/Calibrators - Microbiology Controls/Standards/Calibrators - Microbiology Other Virology Controls - Inf.Imm. Other Virology Controls - Inf.Imm. Rheumatoid/Autoimmune Standards / Calibrators Rheumatoid/Autoimmune Controls Other_MCB Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software Other_MCB Hardware + dedicated accessories + software CH Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software Not for IVD use IC Hardware + dedicated accessories + software Other_MCB Hardware + dedicated accessories + software Not for IVD use SP Hardware + accessories + software SP Hardware + accessories + software Other Substrate - Electrodes / Biosensors Not for IVD use Thymol Faecal Occult Blood (CC) IC =>12.03.90.04 Sm Other Viral Antigen/Antibody Detection Other_HHC Hardware + dedicated accessories + software BG Hardware + dedicated accessories + software SP Hardware + accessories + software SP Hardware + accessories + software SP Hardware + accessories + software SP Hardware + accessories + software

Scleroderma-70 antibody calibrator Scleroderma-70 antibody control Oxytocin calibrator Oxytocin control Rheumatoid factor calibrator Rheumatoid factor control Reticulocyte calibrator Rhesus phenotype calibrator Rhesus phenotype control Monospecific antihuman serum calibrator Monospecific antihuman serum control Mycobacterium susceptibility test calibrator Mycobacterium susceptibility test control Respiratory syncytial virus calibrator Respiratory syncytial virus control Myeloperoxidase antineutrophil cytoplasmic autoantibody calibrator Myeloperoxidase antineutrophil cytoplasmic autoantibody control Incubator, laboratory, <specify> Clinical chemistry analyser, automated, continuous-flow Counter, colony Creatinine analyser Fertility analyser, thermometric Hydrogen gas analyser Nephelometric immunoassay analyser Carbon dioxide monitor, laboratory incubator Tissue flotation bath Blood bank centrifuge Cell washing centrifuge Uric acid electrode Endoscopic light source Thymol Fecal Occult Blood -Rapid Test Sm Meningitis causative agent Hemoglobinometer Analyser, blood grouping Sample processor Clinical chemistry sample processor Haematology sample processor Microbiology sample processor

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 98 of 108

GMDN Term

GMDN Code

42817 42818 42819 42822 42823 42825 42827 42828 42832 42835 42836 42837 42838 42846 42849 42852 42860 42862 42864 42868 42870 42872 42873 42875 42876 42889 42890 42897 42899 42901 42907 42920 42921 42925 42926 42928 42929 42930 42931 42935

EDMA Code

13 01 01 01 11 03 01 90 21 02 10 01 12 06 03 03 21 02 10 01 12 03 01 90 00 00 00 00 00 00 00 00 28 01 10 01 23 01 10 01 00 00 00 00 00 00 00 00 41 01 01 01 15 01 15 01 11 02 01 04 12 06 01 08 12 13 01 03 12 06 90 01 11 01 01 02 11 02 01 02 12 08 02 90 24 09 10 01 41 01 01 01 00 00 00 00 11 03 01 90 12 07 02 10 00 00 00 00 24 09 10 01 12 10 01 13 11 01 01 10 11 01 01 21 12 08 03 90 12 08 02 90 12 08 03 90 15 04 80 90 12 08 03 90 12 08 03 90 11 02 01 90 12 09 01 90 14 02 05 01

EDMA Term

CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) Other Electrolytes IC Hardware + dedicated accessories + software Collagen Type I C-terminal Propeptide IC Hardware + dedicated accessories + software Other Cancer Antigens Not for IVD use Not for IVD use SP Hardware + accessories + software CC Hardware + dedicated accessories + software Not for IVD use Not for IVD use Diagnostics & Clinical Interpretation Supporting Software E. Coli Direct Antigen Detection Urea/Blood Urea Nitrogen Proinsulin Fatty Acid Binding Protein Gastrin Acid Phosphatase (CC) IC => 12.03.01.37 Bile acids Other Central Nervous System TDM Other_MCB Hardware + dedicated accessories + software Diagnostics & Clinical Interpretation Supporting Software Not for IVD use Other Electrolytes Intrinsic Factor (blocking Antibody) Not for IVD use Other_MCB Hardware + dedicated accessories + software SS-B Aspartate Amino-Transferase Lactate Dehydrogenase Isoenzymes Other Antibiotics TDM Other Central Nervous System TDM Other Antibiotics TDM Other Viral Antigen/Antibody Detection Other Antibiotics TDM Other Antibiotics TDM Other Substrates Other drugs of abuse MIC Systems - Manual

Mean corpuscular haemoglobin concentration kit Aluminium kit Fluorimetric immunoassay analyser Type I procollagen-C-propeptide kit CLIA (ChemiLuminescent Immunoassay Analyser) Sialyl Lex antigen kit Pipette shield Blender, clinical laboratory Separator, plasma Counter, cell, differential Analyser, point-of-care, breath, methane Laboratory equipment, agitator Analyser operating system software Escherichia coli vero toxin kit Urea nitrogen kit, unrinalysis Proinsulin kit Heart fatty acid binding protein kit Gastrin kit Acid phosphatase isoenzyme activity kit Glycoholic acid kit Monoamine oxidase kit Laboratory equipment, petri dish filler Software, operating system, analyser Pipette, micro Selenium kit Intrinsic coagulation factor kit 2-5A synthetase kit Bacteria counter Anti-SS-B/La antibody kit Aspartate aminotransferase isoenzyme activity kit Lactate dehydrogenase isoenzyme activity kit Isepamicin kit Haloperidol kit Aprinidine kit West Nile virus kit Zonisamide kit Arbekacin kit Cobalt kit Bromperidol kit Culture medium, antimicrobial susceptibility test, dilution method

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 99 of 108

GMDN Term

Type I collagen-C-telopeptide kit Endotoxin kit Stirrer Vibrio parahaemolyticus serotyping kit Apolipoprotein E kit APR score kit Cholesteryl ester transfer protein kit SV5 virus antibody kit Lipid peroxide kit SV5 virus kit 1,5-Anhydroglucitol kit Pipette, sahli Pipette, diluting Pipette, quantitative, hematology Pipette, pasteur Cancer antigen 602 kit Separator, automated, blood cell Factor Xa inhibitor kit B cell kit Tau protein kit, cerebrospinal fluid Leukocyte kit Monocyte kit Amniotic fluid pH kit Thymocyte kit Natural killer cell kit Basophil count kit Granulocyte kit Electrode, glycated haemoglobin Hepatocyte growth factor kit Tissue plasminogen activator-plasminogen activator inhibitor-1 Anti-acetylcholine receptor antibody kit Anti-cardiolipin beta-2-glycoprotein I complex antibody kit Sodium chloride kit, urinary T cell kit Eosinophil count kit Pan T cell kit Delta-aminolevulinic acid kit, urinary Saliva occult blood kit Leukocyte count kit CALLA-expressing cell kit

GMDN Code

42941 42947 42952 42957 42978 42986 42993 42994 42998 43009 43010 43023 43024 43029 43033 43034 43037 43046 43047 43049 43052 43055 43056 43059 43062 43065 43068 43069 43072 43073 43074 43075 43078 43079 43080 43083 43085 43087 43091 43092

EDMA Code

12 06 03 03 14 02 03 01 00 00 00 00 14 02 03 01 12 01 04 11 12 30 01 90 12 01 03 90 15 04 80 90 12 01 04 90 15 04 80 90 12 06 01 90 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 12 03 01 90 28 01 10 01 13 02 06 06 13 05 01 01 12 01 90 90 13 01 01 01 13 01 01 01 11 90 01 90 13 05 01 01 13 06 01 90 13 01 01 01 13 01 01 01 11 04 03 03 12 03 90 90 13 02 05 07 12 10 90 23 12 10 90 01 11 70 02 90 13 05 01 01 13 01 01 01 13 05 01 01 11 02 01 09 12 03 90 04 13 01 01 01 12 03 01 90

EDMA Term

Collagen Type I C-terminal Propeptide Serotyping (E.coli, Salmonella, Shigella, etc.) Not for IVD use Serotyping (E.coli, Salmonella, Shigella, etc.) Apolipoprotein E Genotyping Sub-typing GT=>16 01 02 03 00 Other Multiple Immunochemistry Reagents Other Transport Proteins Other Viral Antigen/Antibody Detection Other Lipoproteins Other Viral Antigen/Antibody Detection Other Diabetes tests Not for IVD use Not for IVD use Not for IVD use Not for IVD use Other Cancer Antigens SP Hardware + accessories + software Coagulation factor X Inhibitor Antibodies for B and T-cell subtyping Other Other Plasma Proteins CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) Other, Other Clinical Chemistry Reagents Antibodies for B and T-cell subtyping Other Lymphokines /Immunmodulators CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) Glycated Haemoglobin - Electrodes Other Other Tumour Markers Tissue Plasminogen Activator Acetylcholin Receptor Antibodies Anti-Cardiolipin Antibodies Other Urine Testing Antibodies for B and T-cell subtyping CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) Antibodies for B and T-cell subtyping Delta-Aminolaevulinic acid Fecal Occult Blood (IC) CC =>11.70.03.01 CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) Other Cancer Antigens

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 100 of 108

GMDN Term

Erythrocyte count kit LeY-expressing lymphocyte kit Mean corpuscular haemoglobin kit T cell subset kit Ammonia kit, urinary Uropepsin kit, urinary Anti-platelet antibody kit Anti-mitochondrial antibody M2 kit A-/B-transferase kit Catalase kit, urinary Indirect antiglobulin test kit Globulin kit, cerebrospinal fluid Irregular antibody kit Urine specific gravity kit Anti-glomerular basement membrane antibody kit B cell subset kit Prostate specific antigen/alpha-1-antichymotrypsin complex kit Estrone-3-glucuronide self-test kit Homovanillic acid kit Pulmonary adenocarcinoma antigen 130 kit Dehydroepiandrosterone-sulfate kit Culture identification kit, fungal Clostridium perfringens type A kit, heat-resistant Software, application program, analyser Semen analysis system Alkalescens-Dispar identification kit Surfactant protein D kit Galactose transferase kit Cancer antigen 54/61 kit Nuclear matrix protein 22 kit Glycosylated haemoglobin kit p-Aminobenzoic acid kit Phospholipase A2 kit Adenosine deaminase kit Thymol turbidity test kit Zinc sulfate turbidity test kit Buret Microtome, ultra Rotary microtome Cryostat microtome

GMDN Code

43095 43096 43097 43098 43101 43103 43105 43106 43108 43109 43111 43112 43113 43117 43128 43129 43145 43148 43149 43150 43159 43162 43175 43187 43189 43193 43194 43195 43196 43197 43198 43199 43200 43201 43203 43204 43211 43212 43213 43214

EDMA Code

13 01 01 01 12 03 90 90 13 01 01 01 13 05 01 01 11 03 01 01 11 01 01 27 12 10 90 90 12 10 90 02 13 03 01 90 11 01 01 90 13 03 20 01 11 02 01 30 00 00 00 00 11 70 02 90 12 10 90 15 13 05 01 01 12 03 01 32 12 70 05 90 12 09 02 18 12 03 01 90 12 05 01 02 14 03 04 02 15 01 90 90 41 01 01 01 21 02 10 01 14 02 03 01 12 01 04 90 11 01 01 90 12 03 01 90 12 03 90 90 12 06 01 06 00 00 00 00 11 01 01 90 11 01 01 90 11 02 01 27 11 02 01 33 00 00 00 00 23 05 10 01 23 05 10 01 23 05 10 01

EDMA Term

CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) Other Other Tumour Markers CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) Antibodies for B and T-cell subtyping Ammonia Pepsin Other Other Auto-Immune Disease Tests Anti-Mitochondrial Antibodies Other ABO Typing Tests Other Enzymes Coombs Control Cells Total Protein Not for IVD use Other Urine Testing Antibodies to Glomerular Basal Membrane Antibodies for B and T-cell subtyping Total Prostatic Specific Antigen Other Fertility/Pregnancy Rapid Tests Homovanillic Acid Other Cancer Antigens Dehydro-epiandrosterone Sulphate (incl. DHEA) Identification Systems for Fungi - Manual Other Other Bacteriology Immunoassays Diagnostics & Clinical Interpretation Supporting Software IC Hardware + dedicated accessories + software Serotyping (E.coli, Salmonella, Shigella, etc.) Other Lipoproteins Other Enzymes Other Cancer Antigens Other Other Tumour Markers Glycosylated/Glycated Haemoglobin CC=11.02.01.14 Not for IVD use Other Enzymes Other Enzymes Thymol Zinc Not for IVD use HC Hardware + dedicated accessories + software HC Hardware + dedicated accessories + software HC Hardware + dedicated accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 101 of 108

GMDN Term

Laboratory oven, paraffin Paraffin dispenser Chondrocalcin kit (1-3)-beta-D-glucan kit Influenza virus A/B neuraminidase kit Elastase I kit Antibiotic susceptibility testing kit, fungal Rickettsia tsutsugamushi antigen kit Hepatitis B virus DNA polymerase kit Pump, laboratory, high-pressure liquid chromatography Complement CH50 kit Tissue culture bottle Vacuum culture bottle Cortisol kit, serum Ovens, paraffin Molybdenum kit Protein fraction kit Oven, laboratory, paraffin ErbB-2 kit Cadmium kit Conjugated bilirubin kit Manganese kit Blood glucose analyser Phosphoenol pyruvate, ADP, NADH, pyruvate kinase Hyaluronic acid kit Lecithin-cholesterol acyltransferase kit Thyroxine binding capacity kit Type I collagen cross-linked N-telopeptide kit Micro pipette Blender/mixer Shaker/stirrer Factor VIII-associated antigen kit Sialyl Tn antigen kit NCC-ST-439 antigen kit DUPAN-2 antigen kit Human tumour associated carbohydrate antigen kit Mean corpuscular volume kit Cylinder, liquid nitrogen Formulations, paraffin, all Sliding microtome

GMDN Code

43215 43217 43224 43226 43228 43237 43242 43250 43251 43252 43254 43255 43258 43259 43260 43263 43264 43269 43270 43273 43274 43275 43278 43290 43294 43296 43297 43299 43300 43302 43303 43305 43306 43307 43308 43309 43321 43324 43325 43331

EDMA Code

00 00 00 00 00 00 00 00 12 11 01 90 15 06 01 90 15 04 80 04 12 01 90 06 14 03 06 01 15 01 90 05 15 02 02 40 00 00 00 00 12 01 02 11 23 05 30 01 24 09 30 01 12 06 02 04 00 00 00 00 11 03 01 90 11 02 01 35 00 00 00 00 12 03 03 90 11 03 01 90 11 02 01 03 11 02 01 90 21 01 10 01 11 02 01 26 12 11 01 02 11 02 01 19 12 04 01 09 12 06 03 03 00 00 00 00 00 00 00 00 00 00 00 00 13 02 02 07 12 03 01 90 12 03 01 90 12 03 01 90 12 03 01 90 00 00 00 00 00 00 00 00 00 00 00 00 23 05 10 01

EDMA Term

Not for IVD use Not for IVD use Other Rheumatoid Factors Other Mycology Immunoassays Influenza & Para Influenza Trypsin-a1-Antitrypsin (Elastase) Susceptibility Testing Systems for Yeasts and Fungi Rickettsia Hepatitis B Virus - NA Reagents Not for IVD use Total Complement Activity ( CH50 ) HC Consumables Other_MCB Consumables Cortisol Not for IVD use Other Electrolytes Protein Electrophoresis Not for IVD use Other Oncoproteins Other Electrolytes Bilirubin Other Substrates CH Hardware + dedicated accessories + software Pyruvate Anti-Streptococcal Hyaluronidase Lecithin Thyroid binding globulin Collagen Type I C-terminal Propeptide Not for IVD use Not for IVD use Not for IVD use Coagulation factor VIII Other Cancer Antigens Other Cancer Antigens Other Cancer Antigens Other Cancer Antigens Not for IVD use Not for IVD use Not for IVD use HC Hardware + dedicated accessories + software

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 102 of 108

GMDN Term

Bottle, roller, tissue culture Periodontopathic peptidase kit Pancreatic secretory trypsin inhibitor kit 1 to 3-beta-D-glucan kit Haemophilus capsular typing kit Yersinia pseudotuberculosis kit, colony-specific Fibrin/fibrinogen degradation product/fraction E kit Type IV collagen kit Sample concentrator Pipette, manual-induction Creatine kit Super oxide dismutase kit Aluminum kit Porphobilinogen kit, urinalysis Albumin/globulin ratio kit Culture media bottle Detector, electrochemical, liquid chromatography Terminal deoxynucleotidyl transferase kit Oven, microwave, plasma-thawing Eosinophil basic protein kit Soluble fibrin monomer complex kit Anti-SS-A/Ro antibody kit Gamma-seminoprotein kit Plasma thawing unit Container, frozen donor tissue storage Active renin kit BUN analyser Laboratory equipment, mixer Estriol-16-alpha-glucuronide kit Renin kit HIV structural protein-specific antibody kit Beta-human chorionic gonadotropin core kit Histamine kit Separator for therapeutic purposes, membrane automated blood Sialylated carbohydrate antigen KL-6 kit Analyser application program software Pharmacy balance Cystine aminopeptidase kit AIDS-associated virus antibody kit AFP-L3 fraction ratio kit

GMDN Code

43345 43349 43350 43352 43353 43354 43361 43373 43374 43375 43378 43379 43383 43393 43394 43398 43401 43412 43418 43419 43421 43427 43428 43434 43436 43439 43440 43442 43443 43444 43454 43456 43457 43458 43462 43472 43473 43475 43477 43480

EDMA Code

23 05 10 01 15 01 90 90 12 01 90 90 15 06 01 90 15 01 90 10 15 01 90 06 13 02 05 02 12 06 03 90 28 01 10 01 00 00 00 00 11 02 01 07 11 01 01 90 11 03 01 90 11 02 01 25 12 01 03 90 14 01 03 21 05 10 02 12 03 90 90 00 00 00 00 12 01 90 90 13 02 03 03 12 10 01 12 12 03 01 90 00 00 00 00 23 05 30 01 12 06 02 05 21 01 10 01 00 00 00 00 12 05 02 90 12 06 02 05 15 03 01 07 12 05 02 06 12 02 01 90 28 01 10 01 12 03 01 90 41 01 01 01 00 00 00 00 12 06 90 90 15 03 20 04 12 03 90 01

EDMA Term

HC Hardware + dedicated accessories + software Other Other Bacteriology Immunoassays Other Other Plasma Proteins Other Mycology Immunoassays Haemophilus influenzae Yersinia Fibrinogen Degradation Products Other Bone Metabolism Tests SP Hardware + accessories + software Not for IVD use Creatinine Other Enzymes Other Electrolytes Porphobilinogen Other Transport Proteins Prepared Media in Bottles (Bacteriology) HPLC Hardware + dedicated accessories + software Other Other Tumour Markers Not for IVD use Other Other Plasma Proteins Fibrin sensitivity monomer SS-A Other Cancer Antigens Not for IVD use HC Consumables Renine (Plasma Renine Activity) CH Hardware + dedicated accessories + software Not for IVD use Other Pregnancy Testing Hormones Renine (Plasma Renine Activity) HIV 1 Antibody - Confirmatory ß Human Chorionic Gonadotropin (incl. subunit) Other Allergy Tests SP Hardware + accessories + software Other Cancer Antigens Diagnostics & Clinical Interpretation Supporting Software Not for IVD use Other Individual and Specified Hormones HIV Multiple Antibody Alphafetoprotein

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 103 of 108

GMDN Term

Agitator, ultrasonic, for drug dissolution Electrolyte analyser, ion-selective Chemiluminescence immunoassay Analyser Haematocrit centrifuge Bacteriological incubator Laboratory equipment, freezer dryer Complement component C3 proactivator kit Shield, pipette Laboratory balance SPan-1 antigen kit Sialyl Lex-i antigen kit BCA 225 kit Cryobiological storage container Laboratory equipment, blood plasma thawing unit Mixer, laboratory Laboratory equipment, staining apparatus Laboratory equipment, blood separator Laboratory equipment, tissue preparation machine Laboratory equipment, DNA thermal cycler Gel dryer, laboratory Laboratory equipment, evaporation apparatus Freezer/dryer, laboratory Electrophoresis analyser Jaundice meter Laboratory equipment, shaker Laboratory equipment, serum separator Sample tube vacutip inserting device Analyser pump, high-pressure liquid chromatography Analyser injector, high-pressure liquid chromatography Analyser detector, high-pressure liquid chromatography Laboratory equipment, sample alternator Enzyme immunoassay analyser Laboratory equipment, cell splitter Analyser detector, gas chromatography Lab-equipment, cooling tank nitrogen Laboratory equipment, sample processor Petri dish processor Agitator Laboratory equipment, cell separator SV41 virus kit

GMDN Code

43484 43636 43639 43648 43656 43812 43815 43819 43822 43823 43824 43825 43832 43844 43845 43846 43847 43848 43849 43850 43852 43853 43854 43856 43860 43893 43895 43898 43899 43900 43901 43902 43903 43905 43913 43914 43921 43938 43942 43955

EDMA Code

00 00 00 00 21 04 10 01 21 02 10 01 23 09 10 01 24 09 10 01 00 00 00 00 12 01 02 03 00 00 00 00 00 00 00 00 12 03 01 90 12 03 01 90 12 03 01 90 23 05 30 01 00 00 00 00 00 00 00 00 23 05 10 01 28 01 10 01 24 09 10 01 26 01 10 01 00 00 00 00 00 00 00 00 00 00 00 00 21 05 10 01 00 00 00 00 00 00 00 00 28 01 10 01 28 01 10 01 21 05 10 02 21 05 10 02 21 05 10 02 28 01 10 01 21 02 10 01 28 01 10 01 00 00 00 00 00 00 00 00 28 01 10 01 24 09 10 01 00 00 00 00 28 01 10 01 15 04 80 90

EDMA Term

Not for IVD use GE Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software Other_HHC Hardware + dedicated accessories + software Other_MCB Hardware + dedicated accessories + software Not for IVD use Complement Component C3/C3c Not for IVD use Not for IVD use Other Cancer Antigens Other Cancer Antigens Other Cancer Antigens HC Consumables Not for IVD use Not for IVD use HC Hardware + dedicated accessories + software SP Hardware + accessories + software Other_MCB Hardware + dedicated accessories + software NA Hardware + dedicated accessories + software Not for IVD use Not for IVD use Not for IVD use EP Hardware + dedicated accessories + software Not for IVD use Not for IVD use SP Hardware + accessories + software SP Hardware + accessories + software HPLC Hardware + dedicated accessories + software HPLC Hardware + dedicated accessories + software HPLC Hardware + dedicated accessories + software SP Hardware + accessories + software IC Hardware + dedicated accessories + software SP Hardware + accessories + software Not for IVD use Not for IVD use SP Hardware + accessories + software Other_MCB Hardware + dedicated accessories + software Not for IVD use SP Hardware + accessories + software Other Viral Antigen/Antibody Detection

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 104 of 108

GMDN Term

GMDN Code

43957 43964 43982 44016 44017 44018 44019 44020 44021 44022 44023 44024 44026 44027 44028 44029 44030 44031 44038 44048 44049 44082 44115 44146 44147 44153 44154 44155 44164 44169 44170 44171 44172 44174 44175 44176 44177 44178 44179 44180

EDMA Code

24 09 30 01 00 00 00 00 00 00 00 00 15 04 80 10 15 04 40 03 14 50 01 90 15 04 80 07 15 01 07 03 15 01 90 07 15 04 80 90 15 01 15 01 15 01 11 01 15 04 80 06 15 04 80 10 15 01 10 03 15 01 11 01 15 01 15 01 15 01 11 01 15 50 01 04 15 04 40 90 15 50 01 04 41 01 01 01 41 01 01 01 21 02 10 01 21 02 10 01 11 02 01 14 11 02 01 90 00 00 00 00 28 01 10 01 12 01 04 90 12 01 04 90 11 01 01 90 14 02 06 12 06 90 90 12 06 90 90 12 06 90 90 00 00 00 00 11 02 01 04 11 02 01 90 12 06 90 90

EDMA Term

Other_MCB Consumables Not for IVD use Not for IVD use Varicella Zoster Human Papilloma Virus - NA Reagents Other Controls Microbiology Measles Mycobacterial Antibody Assays Bordetella pertussis / parapertussis Other Viral Antigen/Antibody Detection E. Coli Direct Antigen Detection Streptococcal Direct Antigen Detection Rotavirus Varicella Zoster Salmonella Antibody Assays Streptococcal Direct Antigen Detection E. Coli Direct Antigen Detection Streptococcal Direct Antigen Detection Other Virology Controls - Inf.Imm. Other Virology - NA Reagents Other Virology Controls - Inf.Imm. Diagnostics & Clinical Interpretation Supporting Software Diagnostics & Clinical Interpretation Supporting Software IC Hardware + dedicated accessories + software IC Hardware + dedicated accessories + software Glycosylated/Glycated Haemoglobin IC=12.06.01.06 Other Substrates Not for IVD use SP Hardware + accessories + software Other Lipoproteins Other Lipoproteins Other Enzymes Nucleic Acid Identification (Bacteriology) Other Individual and Specified Hormones Other Individual and Specified Hormones Other Individual and Specified Hormones Not for IVD use Urea/Blood Urea Nitrogen Other Substrates Other Individual and Specified Hormones

Vial, challenge, endotoxin Dryer, gel, laboratory Pipette, mechanical Varicella-zoster virus immunoglobulin G kit Papillomavirus nucleic acid kit Endotoxin control Measles virus immunoglobulin G kit Mycobacterium leprae specific antibody kit Bordetella antibody kit Reovirus antibody kit Escherichia coli 0157 antigen kit Group A streptococcal polysaccharide kit Rotavirus antibody kit Varicella-zoster virus immunoglobulin M kit Salmonella typhi antibody kit Group B streptococcus antigen kit Escherichia coli H7 antigen kit Group A beta-hemolytic streptococcus antigen kit West Nile virus calibrator West Nile virus nucleic acid kit West Nile virus control Information system application program software, clinical laboratory Software, clinical laboratory information system FIA (Fluorescent Immunoassay Analyser) EIA (Enzyme Immunoassay Analyser) Glycated albumin kit Mucoprotein kit Beta-closslap kit Haematological separator, <specify> Remnant lipoprotein kit Lipoprotein fraction kit Guanase kit Acid fast bacteria nucleic acid identification kit Amino acid fractionation kit Amino acid fractionation kit, urinary Branched-chain amino acid/tyrosine molar ratio kit p-Aminohippuric acid kit Nonprotein nitrogen kit Polyamine kit Methionine kit

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 105 of 108

GMDN Term

GMDN Code

44181 44198 44199 44200 44201 44202 44203 44204 44206 44210 44211 44217 44219 44228 44229 44236 44238 44239 44250 44252 44253 44254 44257 44259 44275 44281 44289 44290 44291 44292 44293 44300 44308 44309 44310 44311 44316 44317 44321 44324

EDMA Code

12 06 90 90 15 04 80 90 15 02 02 90 15 02 02 90 12 10 90 90 12 10 90 90 14 02 03 01 15 70 01 02 21 04 10 01 00 00 00 00 12 02 01 90 28 01 10 01 00 00 00 00 13 03 01 90 11 01 01 90 12 07 01 05 12 03 90 04 12 06 90 90 13 01 09 90 28 01 10 01 14 02 03 01 12 03 90 12 13 01 01 01 00 00 00 00 14 02 03 01 15 04 80 90 00 00 00 00 00 00 00 00 23 02 10 01 15 02 03 04 12 06 03 90 12 10 01 02 12 10 01 15 13 01 01 01 12 11 01 10 00 00 00 00 28 01 10 01 11 01 01 90 15 04 80 90 15 02 03 04

EDMA Term

Other Individual and Specified Hormones Other Viral Antigen/Antibody Detection Other Hepatitis B Reagents Other Hepatitis B Reagents Other Other Auto-Immune Disease Tests Other Other Auto-Immune Disease Tests Serotyping (E.coli, Salmonella, Shigella, etc.) H. Pylori - Rapid Test GE Hardware + dedicated accessories + software Not for IVD use Other Allergy Tests SP Hardware + accessories + software Not for IVD use Other ABO Typing Tests Other Enzymes Iron Binding Capacity - Total (IC) CC =>11.02.01.17 Fecal Occult Blood (IC) CC =>11.70.03.01 Other Individual and Specified Hormones Other Other Haematology Testing Reagents SP Hardware + accessories + software Serotyping (E.coli, Salmonella, Shigella, etc.) Thymidine Kinase CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) Not for IVD use Serotyping (E.coli, Salmonella, Shigella, etc.) Other Viral Antigen/Antibody Detection Not for IVD use Not for IVD use HS Hardware + dedicated accessories + software HCV Antibody (Total) Other Bone Metabolism Tests ENA Screening Anti-centromere Antibodies CBC-Reagents (Cleaning-/Diluting-/Lysing-/Sheat-fluids) Rheumatoid Factors Not for IVD use SP Hardware + accessories + software Other Enzymes Other Viral Antigen/Antibody Detection HCV Antibody (Total)

Pheylalanine kit Meningitis-causing bacteria capsular polysaccharide antigen kit Hepatitis antigen-albumin receptor complex Hepatitis B virus pre-S2 antigen kit Anti-Mycobacterium antibody kit Anti-Anisakis immunoglobulin G/immunoglobulin A kit Vibrio parahaemolyticus thermostable direct hemolysin kit Helicobacter pylori urease kit Chloridometer Methane breath analyser Histamine release test kit Automated blood cell and plasma separator for therapeutic purposes, Meter, jaundice 2,3-Diphosphoglycerate kit Prolyl hydroxylase kit Unsaturated iron binding capacity kit Gastric occult blood kit Secretin kit Blood specific gravity kit Separator, semi-automated, blood component Kit, test, quality control for endotoxin Deoxythymidine kinase kit Erythrocyte diameter kit Irradiator, blood, extracorporeal Assay, endotoxin activity, chemiluminescent Elisa, antibody, west nile virus Alcohol breath analyser Detector, gas chromatography Platelet aggregation Analyser Hepatitis C virus core protein kit Type IV collagen 7S kit Anti-ENA antibody kit Anti-centromere antibody kit Differential leukocyte count kit Immunoglobulin G rheumatoid factor kit Cell separator Serum separator Ornithine carbamoly transferase kit Japanese encephalitis virus antibody kit Hepatitis C virus core antibody kit

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 106 of 108

GMDN Term

Pregnancy specific protein-1 kit Arginine vasopressin kit D-arabinitol kit Sorbitol kit Lipoprotein lipase kit Lipoprotein X kit MRSA coagulase typing kit Beta-lipoprotein kit PIVKA-II kit Anti-agalactsyl immunoglobulin G kit Apolipoprotein C-III kit Apolipoprotein C-II kit Granulocyte elastase kit Cortisol kit, urinalysis Injector, laboratory, high-pressure liquid chromatography Culture identification kit, Mycobacterium Processor, petri dish Factor VIII ristocetin cofactor activity kit Activated protein C-resisant factor V kit Platelet aggregation kit Luminescent immunoassay analyser Pyruvate kinase kit GOR antibody kit Hepatitis C virus group-specific antigen kit Rickettsia tsutsugamushi antibody kit Lung cancer-associated protein kit Major Bcr-Abl nucleic acid kit L-fucose kit Pancreatic oncofetal antigen kit Glycosylated haemoglobin control Galactose-1-phosphate uridyl transferase kit Progastrin releasing peptide precursor kit Thrombomodulin kit Basic foetoprotein kit Surfactant apoprotein A kit Serum amyloid A protein kit Human brain natriuretic peptide kit Procollagen III peptide kit Antibiotic susceptibility testing kit, bacterial Bacterial toxin detection kit

GMDN Code

44325 44329 44342 44343 44352 44375 44376 44378 44379 44385 44391 44392 44398 44399 44407 44408 44413 44416 44418 44419 44420 44421 44425 44426 44428 44430 44431 44432 44433 44435 44436 44438 44439 44440 44441 44442 44443 44444 44448 44449

EDMA Code

12 05 02 08 12 06 04 08 15 06 01 02 11 01 01 29 11 01 01 23 12 01 04 90 13 03 04 07 11 02 01 20 12 03 90 90 12 10 90 90 12 01 04 90 12 01 04 90 12 01 90 90 12 06 02 04 21 05 30 02 14 01 03 10 24 09 10 01 13 02 02 07 13 02 06 11 13 02 04 01 21 02 10 01 11 01 01 90 12 10 90 90 15 02 03 01 15 01 90 05 12 03 03 90 12 03 90 90 11 02 01 90 12 03 01 90 12 50 01 16 14 02 05 90 12 06 90 90 13 02 06 90 12 03 90 01 12 01 04 90 12 01 90 90 12 13 01 01 12 06 03 04 14 02 05 01 14 90 90 90

EDMA Term

Pregnancy Specific B1 -glycoprotein Vasopressin Candida albicans Sorbitol Dehydrogenase Lipase Other Lipoproteins Enzymes (e.g. Bromelin / Papain, etc.) Lipoprotein, Chemical determination/detection Other Other Tumour Markers Other Other Auto-Immune Disease Tests Other Lipoproteins Other Lipoproteins Other Other Plasma Proteins Cortisol HPLC Consumables Mycobacteria media (Bottles) Other_MCB Hardware + dedicated accessories + software Coagulation factor VIII APC Resistance Aggregation Factors IC Hardware + dedicated accessories + software Other Enzymes Other Other Auto-Immune Disease Tests HCV Antigen Rickettsia Other Oncoproteins Other Other Tumour Markers Other Substrates Other Cancer Antigens Individual and Specified Hormones Controls Other Manual Susceptibility Testing Other Individual and Specified Hormones Other Coagulation Inhibitors Alphafetoprotein Other Lipoproteins Other Other Plasma Proteins Atrial- Brain Natriuric Peptide (incl. Pro-ANP/BNP) Collagen Type III C-terminal Propeptide MIC Systems - Manual Other Other Microbiology Tests

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 107 of 108

GMDN Term

Fungal identification kit Culture identification kit, bacterial Antibiotic sensitivity tester Chromium kit 3-Hydroxybutyric acid self-test kit Vitamin D kit, multiple hydroxylated metabolite Test strip kit, leukocyte, urinalysis 3a-diol-G kit Blood culture bottle Pipette, electronic, single-function Matrix metalloproteinase-3 kit Laboratory equipment, gel dryer Cholesterol kit, free

GMDN Code

44450 44456 44497 44558 44562 44587 44611 44612 44644 44646 44647 44652 44653

EDMA Code

14 03 04 02 14 02 02 24 01 10 01 11 02 01 90 11 70 01 90 12 06 03 10 11 70 02 01 12 05 01 12 14 01 06 01 00 00 00 00 12 03 90 16 00 00 00 00 11 02 01 05

EDMA Term

Identification Systems for Fungi - Manual Biochemical Identification - Manual SI Hardware + dedicated accessories + software Other Substrates Other Blood Test Strips 25-Hydroxyvitamin D3 Urine Single Test Strips (incl. tablets) Androstanediol-Glucuronide Adult Bottles (Blood Culture -Autom.) Not for IVD use Matrix-Metalloproteinases Not for IVD use Cholesterol

http://www.CE-marking.com/GMDN-EDMA-Codes.pdf

www.CE-marking.com

www.CE-marking.eu

Page 108 of 108

Information

Microsoft Word - GMDN_EDMA_Codes.rtf

108 pages

Report File (DMCA)

Our content is added by our users. We aim to remove reported files within 1 working day. Please use this link to notify us:

Report this file as copyright or inappropriate

115832


You might also be interested in

BETA
nyquistman.mss
ASTM Complete Index
Microsoft Word - GMDN_EDMA_Codes.rtf