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GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit
EUDAMEDClass C (EU MDR)
Ref HHV/GP/100
Identity
- Trade Name
- GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit EUDAMED
- Device Name
- GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit EUDAMED
- Model / Reference
- HHV/GP/100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595696300166 EUDAMED
- Basic UDI-DI
- 859569630005QB EUDAMED
- EMDN Code
- W0105040524 HHV-6,7,8 - 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 Human Herpesvirus 6/7 (HHV-6/7) 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 | 859569630005QB | Class C | Active |
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Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (1)
- EUDAMED 81ad5db3-f3fe-479a-861d-0e4049b52a57 61 fields · synced Oct 7, 2026