Identity
- Trade Name
- GeneProof BK Virus (BKV) PCR Kit EUDAMED
- Device Name
- GeneProof BK Virus (BKV) PCR Kit EUDAMED
- Model / Reference
- BKV/GP/100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594161959267 EUDAMED
- Basic UDI-DI
- 859569630027QM EUDAMED
- EMDN Code
- W0105040522 BK VIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Czechia 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
GeneProof BK Virus (BKV) PCR Kit by GeneProof a.s. — 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 | 859569630027QM | Class C | Active |
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Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (2)
- EUDAMED 5a8f8cf4-f0fd-419b-9685-2e382a4aa18a 61 fields · synced Jul 20, 2026
- EUDAMED b6221102-6b3e-4536-ae40-aca78b2af182 61 fields · synced Jul 20, 2026