← Back to catalogue
TaqPath™ Menu | GeneProof™ Cytomegalovirus (CMV) PCR Kit
EUDAMEDClass C (EU MDR)
Ref A58428
Identity
- Trade Name
- TaqPath™ Menu | GeneProof™ Cytomegalovirus (CMV) PCR Kit EUDAMED
- Device Name
- GeneProof Cytomegalovirus (CMV) PCR Kit EUDAMED
- Model / Reference
- A58428 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595696304355 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
TaqPath™ Menu | 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (2)
- EUDAMED 029eb511-403d-4f2d-88fd-1a721cb928c5 61 fields · synced Jun 18, 2026
- EUDAMED 6c54e199-9418-4b70-8c51-2b9e6f7364ce 61 fields · synced Jun 18, 2026