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Reveal Rapid HIV Test
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 815311000607Model LAB +Ref 815311000577Model 815311000577 HIV POC
Identity
- Trade Name
- Reveal Rapid HIV Test EUDAMED
- Device Name
- Reveal Rapid HIV Test EUDAMED
- Model / Reference
- LAB + EUDAMED815311000607 EUDAMED815311000577 HIV POC EUDAMED815311000577 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8153110006075R EUDAMEDD-81531100057769 EUDAMED
- Basic UDI-DI
- B-8153110006075R EUDAMEDB-81531100057769 EUDAMED
- EMDN Code
- W0105900201,W0204 EUDAMEDW0105090302,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-8153110006075R | 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 (2)
- EUDAMED 5ad71c34-7789-4b0a-bd85-a69b5f8a3712 61 fields · synced Oct 7, 2026
- EUDAMED 76f8beca-0a32-421e-a060-e70147fa0d2d 61 fields · synced May 18, 2026