← Back to catalogue
Genedrive® CYP2C19 Control Kit
EUDAMEDClass A (EU MDR)
Ref CYP2C19-CTRL10-FRRef CYP2C19-CTRL10-ESRef CYP2C19-CTRL10-PTRef CYP2C19-CTRL10-DERef CYP2C19-CTRL10 Ref CYP2C19-CTRL10-ITRef CYP2C19-CTRL10-NL
Identity
- Trade Name
- Genedrive® CYP2C19 Control Kit EUDAMED
- Device Name
- Genedrive® CYP2C19 Control Kit EUDAMED
- Model / Reference
- CYP2C19-CTRL10-FR EUDAMEDCYP2C19-CTRL10-ES EUDAMEDCYP2C19-CTRL10-PT EUDAMEDCYP2C19-CTRL10-DE EUDAMEDCYP2C19-CTRL10 EUDAMEDCYP2C19-CTRL10-IT EUDAMEDCYP2C19-CTRL10-NL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060654860592 EUDAMED05060654860615 EUDAMED05060654860653 EUDAMED05060654860646 EUDAMED05060654860585 EUDAMED05060654860622 EUDAMED05060654860608 EUDAMED
- Basic UDI-DI
- 506065486CYP2C19-CTRL01RT EUDAMED
- Unit of Use DI
- 05060654860578 EUDAMED
- EMDN Code
- W0106030101 CYP 450 - INDIVIDUAL TEST EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMEDSpain EUDAMEDPortugal EUDAMEDGermany EUDAMEDNetherlands EUDAMEDItaly 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 Control Kit by Genedrive Diagnostics Ltd — Class A — 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 | 506065486CYP2C19-CTRL01RT | Class A | 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 (7)
- EUDAMED bdad3d95-69b6-48ba-9cf6-72c32b820b5c 61 fields · synced Sep 18, 2026
- EUDAMED 1f0d5314-e089-4b26-b31d-1444060ab4b3 61 fields · synced May 17, 2026
- EUDAMED 6b6a0b2a-a4f1-49ab-b712-b2da67d3b513 61 fields · synced May 17, 2026
- EUDAMED e735d8ee-5277-49c0-8803-fdf7159c8135 61 fields · synced May 17, 2026
- EUDAMED 557160e3-6062-4044-8898-eb5ca629b840 61 fields · synced May 17, 2026
- EUDAMED 319a869c-4d3f-41c9-94bb-6897fcff48da 61 fields · synced May 18, 2026
- EUDAMED 5c208d48-2304-4e58-b363-ba629c6b80a0 61 fields · synced May 18, 2026