Genekam Biotechnology AG
DE-MF-000035227 · Germany · Duisburg
Genekam Biotechnology AG is registered in the European database on medical devices as a manufacturer, with 37 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- D0020-Ureaplasma urealyticum-Positive PCR-Control
- D0037-Mycoplasma hominis-Positive PCR-Control
- FR006-FluHunter: Avian Influenza Virus H5N1 (Realtime PCR-Kit)
- FR166-Yellow Fever Virus -(Realtime PCR-Kit)
- FR325-Zika Virus-Single Check (Realtime PCR-Kit)
- FR475-Fluhunter: SARS-CoV-2 (Realtime PCR-Kit)
- FR799
- FR799-Identification of human specific ß-Actin
- K068-Ureaplasma urealyticum (Ready to use PCR-Kit)
- K201-Plasmodium falciparum
- K404-Plasmodium vivax
- K740-Detection of Borrelia burgdorferi
Showing 12 of 37 declared devices.
Catalogue references include FR166, FR325, FR475, FR799, K201, K404.
European nomenclature codes declared: W0105010803, W0105080908, W0599, W0105040599, W0105011604, W0105050209.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 37 |
| 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 | 37 |
|---|---|
| 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. Genekam Biotechnology AG was not found in either the U.S. or the Canadian register.