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GeneProof Cytomegalovirus (CMV) PCR Kit
EUDAMEDClass C (EU MDR)
Ref CMV/GP/100Ref CMV/GP/025
Identity
- Trade Name
- GeneProof Cytomegalovirus (CMV) PCR Kit EUDAMED
- Device Name
- GeneProof Cytomegalovirus (CMV) PCR Kit EUDAMED
- Model / Reference
- CMV/GP/100 EUDAMEDCMV/GP/025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594161958413 EUDAMED08594161958390 EUDAMED
- Basic UDI-DI
- 859569630009QK EUDAMED
- EMDN Code
- W0105040205 CMV - 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 Cytomegalovirus (CMV) 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 | 859569630009QK | Class C | Active |
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Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (4)
- EUDAMED de1b8f8d-e37c-49dc-9c26-0776b137b225 61 fields · synced Oct 6, 2026
- EUDAMED 2090ae34-eeec-4453-a3fc-ae653855609d 61 fields · synced May 18, 2026
- EUDAMED e6c655fa-48a7-443d-acfc-c69e686c9e3a 61 fields · synced Jul 9, 2026
- EUDAMED 7b8a65ba-0af6-4bd3-8b6a-33e307a72389 61 fields · synced Sep 18, 2026