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Influenza A/B Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref A1A324020007，A1A324020019，A1A324020031Model Type A, Type B, Type C
Identity
- Device Name
- Influenza A/B Antigen Rapid Test EUDAMED
- Model / Reference
- Type A, Type B, Type C EUDAMEDA1A324020007，A1A324020019，A1A324020031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971100211372 EUDAMED
- Basic UDI-DI
- B-06971100211372 EUDAMED
- EMDN Code
- W0105099004 INFLUENZA A AND /OR B - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Influenza A/B Antigen Rapid Test by Xiamen Wiz Biotech 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-06971100211372 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Wiz Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000029590
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED d2ee0682-7788-4d9e-94b0-b99895265a9a 61 fields · synced Jul 28, 2026