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HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood +2 more)
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref HIV-W23Model Device
Identity
- Trade Name
- HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma) EUDAMED
- Device Name
- HIV Rapid Test Device (Whole blood/Serum/Plasma) EUDAMED
- Model / Reference
- Device EUDAMEDHIV-W23 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804810726 EUDAMED
- Basic UDI-DI
- B-06952804810726 EUDAMED
- EMDN Code
- W0105090302 HIV 1 / 2 - RT & POC EUDAMED
- Models / Variants
- Whole Blood EUDAMEDSerum EUDAMEDPlasma EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood +2 more) by Assure Tech. (hangzhou) Co., Ltd. — Class IVD Annex II List A — IVDD — listed…
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-06952804810726 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 7dce479e-25e0-494e-b915-c328be3f5fe5 61 fields · synced Aug 4, 2026