AB Diagnostic Systems GmbH
DE-MF-000025407 · Germany · Berlin
AB Diagnostic Systems GmbH is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: DK.003.01.3, DK.003.05.3, DK.006.01.3, DK.013.01.3, DK.013.05.3.
Devices declared under this manufacturer
- abia HBs Ag
- abia HEV IgG
- abia HEV IgM
- abia HIV AgAb
- abia IgE total
- abia TSH
Catalogue references include DK.0003.05.3, DK.003.01.3, DK.013.01.3, DK.013.05.3, DK.029.01.3, DK.029.05.3.
European nomenclature codes declared: W0105020201, W0105030404, W0105020505, W0105020504, W01020201, W0102100304.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 10 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 10 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. AB Diagnostic Systems GmbH was not found in either the U.S. or the Canadian register.