Identity
- Device Name
- AiD anti-HIV 1+2 ELISA EUDAMED
- Model / Reference
- WI-4396 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970301452393 EUDAMED
- Basic UDI-DI
- B-06970301452393 EUDAMED
- EMDN Code
- W0105030402 HIV MULTIPLE ANTIBODY EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
AiD anti-HIV 1+2 ELISA by Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. — Class IVD Annex II List A — IVDD — listed in EUDAMED
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-06970301452393 | Class IVD Annex II List A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000040626
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED deb59c60-ce00-46a4-9e2e-ae1513586cb8 61 fields · synced Aug 2, 2026