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AUTOTESTE DE VIH OraQuick
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 1001-0601
Identity
- Trade Name
- AUTOTESTE DE VIH OraQuick EUDAMED
- Device Name
- OraQuick HIV Self-Test, CE, Spain/Portugal, 25 Count Kit EUDAMED
- Model / Reference
- 1001-0601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10608337001515 EUDAMED
- Basic UDI-DI
- B-10608337001515 EUDAMED
- EMDN Code
- W0105090302 HIV 1 / 2 - RT & POC EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
AUTOTESTE DE VIH OraQuick by OraSure Technologies, 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-10608337001515 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- OraSure Technologies, Inc.
- EUDAMED SRN
- US-MF-000009941
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED b58a470f-a0ed-494f-b2b7-66a5b2e48653 61 fields · synced Jul 19, 2026