Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
DE-MF-000025295 · Germany · Frankfurt am Main
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- PoET B19V
- PoET Extraction
- PoET HAV
- PoET HBV
- PoET HCV
- PoET HEV
- PoET HEV Positive Control
- PoET HIV
- PoET Instrument
- PoET Master Positive Control
- PoET Negative Control
- PoET Prep Reagent
Showing 12 of 15 declared devices.
Catalogue references include P1B-24-20, P2A-28-30, P2B-28-30, P2D-28-30, P2E-28-30, P2F-28-30.
European nomenclature codes declared: W0105080808, W0105900101, W0105020507, W0105040509, W0105020105, W0105020307.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 15 |
| 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 | 15 |
|---|---|
| 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. Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH was not found in either the U.S. or the Canadian register.