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GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref HCVD/ISEX/025Ref HCVD/ISEX/100
Identity
- Trade Name
- GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit EUDAMED
- Device Name
- GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit EUDAMED
- Model / Reference
- HCVD/ISEX/025 EUDAMEDHCVD/ISEX/100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594161956914 EUDAMED08594161956891 EUDAMED
- Basic UDI-DI
- B-08594161956914 EUDAMEDB-08594161956891 EUDAMED
- EMDN Code
- W0105020307 HEPATITIS C VIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit by GeneProof a.s. — Class IVD Annex II List A — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08594161956914 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (4)
- EUDAMED 1b00d1af-103d-4f23-9899-9bafcdd34892 61 fields · synced Jul 10, 2026
- EUDAMED 3de5e44b-afce-4c31-a4b3-bf1e42525beb 61 fields · synced May 18, 2026
- EUDAMED 7441ca4a-0d19-4a83-8928-dd5565490ba4 61 fields · synced Jul 8, 2026
- EUDAMED 0b880d2f-e3e0-453f-8cc4-fe8b35950a7a 61 fields · synced Jul 10, 2026