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SARS-CoV-2 Antigen Test
EUDAMEDClass IVD General (EU MDR)
Ref A1C320020005, A1C320020015Model Type A, Type B.
Identity
- Device Name
- SARS-CoV-2 Antigen Test EUDAMED
- Model / Reference
- Type A, Type B. EUDAMEDA1C320020005, A1C320020015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971100211396 EUDAMED
- Basic UDI-DI
- B-06971100211396 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
A self-testing SARS-CoV-2 antigen test for quick and accurate COVID-19 diagnosis, featuring a comprehensive testing process and user-friendly interface. This device is designed for healthcare professionals and individuals seeking rapid and reliable results.
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-06971100211396 | 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 (2)
- EUDAMED 6c1fa537-bb26-4822-b9a8-96ec84c893c2 61 fields · synced Jul 9, 2026
- EUDAMED 6c1fa537-bb26-4822-b9a8-96ec84c893c2-1 61 fields · synced Jun 10, 2026