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Hiv 1& 2 Self-Test
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 809062-1ENSModel 800062-x
by PRIMA Lab SA
Identity
- Device Name
- HIV 1& 2 SELF-TEST EUDAMED
- Model / Reference
- 800062-x EUDAMED809062-1ENS EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-809062-1B8 EUDAMED
- Basic UDI-DI
- B-809062-1B8 EUDAMED
- EMDN Code
- W0105090302 HIV 1 / 2 - RT & POC EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Hiv 1& 2 Self-Test by PRIMA Lab SA — 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-809062-1B8 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- PRIMA Lab SA
- EUDAMED SRN
- CH-MF-000034473
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 88af29c5-a000-425e-bcb5-92c4eee6ca80 61 fields · synced Jul 25, 2026