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GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref HIV1D/GP/100Ref HIV1D/GP/025
Identity
- Trade Name
- GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit EUDAMED
- Device Name
- GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit EUDAMED
- Model / Reference
- HIV1D/GP/100 EUDAMEDHIV1D/GP/025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595696300821 EUDAMED08595696300807 EUDAMED
- Basic UDI-DI
- B-08595696300821 EUDAMEDB-08595696300807 EUDAMED
- EMDN Code
- W0105030107 HIV 1 - 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 HIV type 1 (HIV-1) 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-08595696300821 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (4)
- EUDAMED 3df0b4da-887e-4193-8fee-d99bc2e662b2 61 fields · synced Jul 29, 2026
- EUDAMED 758a7234-cfa9-44e7-8d75-258013abb9ca 61 fields · synced May 19, 2026
- EUDAMED e298654d-930d-4f11-80c3-45ea411f4a50 61 fields · synced Jul 9, 2026
- EUDAMED 6abe332c-7ddd-4877-9beb-e06b5d24b808 61 fields · synced Jul 29, 2026