← Back to catalogue
SARS-CoV-2/Influenza A/Influenza B Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref A1A325020007, A1A325020019, A1A325020031Model Type A, Type B, Type C
Identity
- Device Name
- SARS-CoV-2/Influenza A/Influenza B Antigen Rapid Test EUDAMED
- Model / Reference
- Type A, Type B, Type C EUDAMEDA1A325020007, A1A325020019, A1A325020031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971100211389 EUDAMED
- Basic UDI-DI
- B-06971100211389 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER 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
SARS-CoV-2/Influenza A/Influenza B Antigen Rapid Test by Xiamen Wiz Biotech Co., Ltd. — Class IVD General — 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-06971100211389 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Wiz Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000029590
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 988869b4-eb3a-4e54-b722-7543d6e7857f 61 fields · synced May 23, 2026