← Back to catalogue
Genedrive® CYP2C19 ID Kit
EUDAMEDClass C (EU MDR)
Ref ID-CYP2C19-10 Ref ID-CYP2C19-10-ITRef ID-CYP2C19-10-ELRef ID-CYP2C19-10-PTRef ID-CYP2C19-10-FRRef ID-CYP2C19-10-NL
Identity
- Trade Name
- Genedrive® CYP2C19 ID Kit EUDAMED
- Device Name
- Genedrive® CYP2C19 ID Kit EUDAMED
- Model / Reference
- ID-CYP2C19-10 EUDAMEDID-CYP2C19-10-IT EUDAMEDID-CYP2C19-10-EL EUDAMEDID-CYP2C19-10-PT EUDAMEDID-CYP2C19-10-FR EUDAMEDID-CYP2C19-10-NL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060654860486 EUDAMED05060654860523 EUDAMED05060654860530 EUDAMED05060654860554 EUDAMED05060654860493 EUDAMED05060654860509 EUDAMED
- Basic UDI-DI
- 506065486ID-CYP2C19-0197 EUDAMED
- Unit of Use DI
- 05060654860479 EUDAMED
- EMDN Code
- W0106030101 CYP 450 - INDIVIDUAL TEST EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Netherlands EUDAMEDItaly EUDAMEDGreece EUDAMEDPortugal EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Genedrive® CYP2C19 ID Kit by Genedrive Diagnostics Ltd — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 506065486ID-CYP2C19-0197 | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genedrive Diagnostics Ltd.
- EUDAMED SRN
- GB-MF-000012810
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (6)
- EUDAMED 39493342-6eb5-47d9-bc84-d95e4ac7f137 61 fields · synced Jul 28, 2026
- EUDAMED fc6f3c36-7ce1-4f8c-aacd-04542fc68f0c 61 fields · synced May 17, 2026
- EUDAMED e6696194-2c13-499c-bebd-624d50dd6a40 61 fields · synced May 17, 2026
- EUDAMED 66963649-8699-4304-811b-412fba70a2ee 61 fields · synced May 17, 2026
- EUDAMED aaf14f12-d1d2-4331-a606-94fd37c6b1db 61 fields · synced May 18, 2026
- EUDAMED f7a52d80-408e-4d6c-8a10-2e1ca146b085 61 fields · synced May 19, 2026