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Reveal Rapid HIV Test
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 815311000690Model 815311000690 HIV LAB S/P
Identity
- Trade Name
- Reveal Rapid HIV Test EUDAMED
- Device Name
- Reveal Rapid HIV Test EUDAMED
- Model / Reference
- 815311000690 HIV LAB S/P EUDAMED815311000690 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-81531100069066 EUDAMED
- Basic UDI-DI
- B-81531100069066 EUDAMED
- EMDN Code
- W0105900201,W0204 EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Reveal Rapid HIV Test by MedMira Laboratories Inc — 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-81531100069066 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- MedMira Laboratories Inc.
- EUDAMED SRN
- CA-MF-000013928
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 82f5a297-3170-4f44-af92-8f853506a99b 61 fields · synced May 22, 2026