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Genedrive® CYP2C19 Collection Kit
EUDAMEDClass A (EU MDR)
Ref CK-CYP2C19-10-PTRef CK-CYP2C19-10-PLRef CK-CYP2C19-10-FRRef CK-CYP2C19-10Ref CK-CYP2C19-10-DERef CK-CYP2C19-10-ELRef CK-CYP2C19-10-ITRef CK-CYP2C19-10-TR
Identity
- Trade Name
- Genedrive® CYP2C19 Collection Kit EUDAMED
- Device Name
- Genedrive® CYP2C19 Collection Kit EUDAMED
- Model / Reference
- CK-CYP2C19-10-PT EUDAMEDCK-CYP2C19-10-PL EUDAMEDCK-CYP2C19-10-FR EUDAMEDCK-CYP2C19-10 EUDAMEDCK-CYP2C19-10-DE EUDAMEDCK-CYP2C19-10-EL EUDAMEDCK-CYP2C19-10-IT EUDAMEDCK-CYP2C19-10-TR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060654860820 EUDAMED05060654860868 EUDAMED05060654860769 EUDAMED05060654860752 EUDAMED05060654860813 EUDAMED05060654860806 EUDAMED05060654860790 EUDAMED05060654860837 EUDAMED
- Basic UDI-DI
- 506065486CK-CYP2C19-019L EUDAMED
- Unit of Use DI
- 05060654860745 EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Portugal EUDAMEDPoland EUDAMEDFrance EUDAMEDGermany EUDAMEDGreece EUDAMEDItaly EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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 Collection 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 | 506065486CK-CYP2C19-019L | 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 (8)
- EUDAMED a2a21afb-f5f3-4d43-b373-cbaff869df52 61 fields · synced Jul 30, 2026
- EUDAMED 8fdb6cfe-2e37-4e25-a2cf-a409c5cda3de 61 fields · synced May 17, 2026
- EUDAMED 2077000f-3262-438e-82fb-aa5fe45f1f35 61 fields · synced May 17, 2026
- EUDAMED 02fec949-d802-47a8-b610-556a396b0187 61 fields · synced May 17, 2026
- EUDAMED bb29eaf1-e373-4da2-b453-e6c43110ab9a 61 fields · synced May 17, 2026
- EUDAMED 1244827d-7b07-4dd9-98a2-48fbb5d16d7f 61 fields · synced May 18, 2026
- EUDAMED 201e4816-f076-45e7-8557-9d290ba9ab04 61 fields · synced May 18, 2026
- EUDAMED b28b738f-b8ee-4c92-96cf-be30be130117 61 fields · synced May 18, 2026