← Back to catalogue
TaqPath™ Menu | GeneProof™ Hepatitis C Virus (HCV) Diagnostic PCR Kit
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref A58427
Identity
- Trade Name
- TaqPath™ Menu | GeneProof™ Hepatitis C Virus (HCV) Diagnostic PCR Kit EUDAMED
- Device Name
- GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit EUDAMED
- Model / Reference
- A58427 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595696304348 EUDAMED
- Basic UDI-DI
- B-08595696304348 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
TaqPath™ Menu | GeneProof™ Hepatitis C Virus (HCV) Diagnostic PCR Kit by GeneProof a.s. — Class IVD Annex II List A — IVDD — listed in EUDAMED
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-08595696304348 | Class IVD Annex II List A | 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 157b5eb8-78df-4c4a-abd0-ad767b52de69 61 fields · synced Oct 6, 2026
- EUDAMED 5c5a1938-11d8-40be-8865-7a3a3f117e84 61 fields · synced Jul 24, 2026