Identity
- Trade Name
- Genedrive® CYP2C19 Control Kit EUDAMED
- Device Name
- Genedrive® CYP2C19 Control Kit EUDAMED
- Model / Reference
- CYP2C19-CTRL10-EL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060654860639 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
- Greece 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 |
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Manufacturer
- Manufacturer
- Genedrive Diagnostics Ltd.
- EUDAMED SRN
- GB-MF-000012810
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED bfe372f2-a386-487d-8cb5-8d8ddee630fc 61 fields · synced Jun 18, 2026