Genedrive Diagnostics Ltd.
GB-MF-000012810 · United Kingdom · Manchester
Genedrive Diagnostics Ltd. is registered in the European database on medical devices as a manufacturer, with 38 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- Genedrive® CYP2C19 Collection Kit
- Genedrive® CYP2C19 Control Kit
- Genedrive® CYP2C19 ID Kit
- Genedrive® MT-RNR1 Control Kit
- Genedrive® MT-RNR1 ID Kit
- Genedrive® MT-RNR1 Negative Control Kit
- Genedrive® MT-RNR1 Positive Control Kit
- Genedrive® System
Showing 12 of 38 declared devices.
Catalogue references include CK-CYP2C19-10-ES, CK-CYP2C19-10-IT, CYP2C19-CTRL10-EL, GS-002 V6.0, ID-CYP2C19-10-ES, ID-CYP2C19-10-PL.
European nomenclature codes declared: W0106030101, W05019099, W0106010199, W02050301.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 38 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 38 |
|---|---|
| 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. Genedrive Diagnostics Ltd. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITDA/00006/0v003 | amended | 2030-05-27 |
IQMS/00016/0v001 | issued | 2030-05-27 |