Identity
- Trade Name
- Bio-Firm EUDAMED
- Device Name
- Influenza A+B Rapid Test Cassette EUDAMED
- Model / Reference
- WI-FLU-C82-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-WI-FLU-C82-10H9 EUDAMED
- Basic UDI-DI
- B-WI-FLU-C82-10H9 EUDAMED
- EMDN Code
- W0105099004 INFLUENZA A AND /OR B - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
No
EUDAMED
Bio-Firm by Zhejiang Wantaifu Biotechnology Co., Ltd — Class IVD General — 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-WI-FLU-C82-10H9 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Wantaifu Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000037582
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED c335c5e5-ddc0-4c56-80fa-a4eba1a5506f 61 fields · synced Jun 18, 2026