Identity
- Trade Name
- HIVFIND EUDAMED
- Device Name
- HIVFIND™ Oral Fluid HIV 1/2 Antibody Detection Self Test EUDAMED
- Model / Reference
- HIVSST-01 EUDAMEDHIVSST-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08905459004734 EUDAMED
- Basic UDI-DI
- 8905459HIVOSF9V EUDAMED
- Direct Marketing DI
- 08905459004734 EUDAMED
- EMDN Code
- W0105090302 HIV 1 / 2 - RT & POC EUDAMED
Classification
- Device Class
- Class D EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
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
New Device
No
EUDAMED
Hivfind by Meril Diagnostics Pvt. Ltd. — Class D — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8905459HIVOSF9V | Class D | Active |
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Manufacturer
- Manufacturer
- Meril Diagnostics Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000028158
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED b6794f85-17fc-4995-b5da-ab25f0c4b0c7 61 fields · synced Jun 18, 2026