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GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit
EUDAMEDClass C (EU MDR)
Ref HSV/GP/100Ref HSV/GP/025
Identity
- Trade Name
- GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit EUDAMED
- Device Name
- GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit EUDAMED
- Model / Reference
- HSV/GP/100 EUDAMEDHSV/GP/025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595696300227 EUDAMED08595696300210 EUDAMED
- Basic UDI-DI
- 859569630008QH EUDAMED
- EMDN Code
- W0105040311 HSV - 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 Herpes Simplex Virus (HSV-1/2) 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 | 859569630008QH | Class C | Active |
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Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (3)
- EUDAMED 36a84ca0-9acb-4e23-94a0-915c5a7ba94d 61 fields · synced Jul 15, 2026
- EUDAMED 914d9cba-55b3-46f6-88b9-2991ecf35256 61 fields · synced May 17, 2026
- EUDAMED 70354516-2abf-41a1-89d3-0a22920907ef 61 fields · synced Jul 15, 2026