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GeneProof Hepatitis B Virus (HBV) PCR Kit
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref HBV/ISEX/025Ref HBV/ISEX/100
Identity
- Trade Name
- GeneProof Hepatitis B Virus (HBV) PCR Kit EUDAMED
- Device Name
- GeneProof Hepatitis B Virus (HBV) PCR Kit EUDAMED
- Model / Reference
- HBV/ISEX/025 EUDAMEDHBV/ISEX/100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594161952015 EUDAMED08594161952039 EUDAMED
- Basic UDI-DI
- B-08594161952015 EUDAMEDB-08594161952039 EUDAMED
- EMDN Code
- W0105020216 HEPATITIS B 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
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
GeneProof Hepatitis B Virus (HBV) 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-08594161952015 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (4)
- EUDAMED c32abeaa-dc1a-4025-95db-6cc9aad9232a 61 fields · synced Jul 11, 2026
- EUDAMED 33625fd4-388a-4d56-852c-5213417951d1 61 fields · synced May 18, 2026
- EUDAMED 24273efc-d412-45e4-af7b-8675d99b50e3 61 fields · synced Jul 11, 2026
- EUDAMED ee6e662e-c16a-4244-9ac7-9ce7b7229a5b 61 fields · synced Jul 11, 2026