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Biobase COVID-19 Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref 20 Tests/kit（DR1138-5）Model 20 Tests/kit
Identity
- Trade Name
- Biobase COVID-19 Antigen Rapid Test EUDAMED
- Device Name
- Biobase COVID-19 Antigen Rapid Test EUDAMED
- Model / Reference
- 20 Tests/kit EUDAMED20 Tests/kit（DR1138-5） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969980502 EUDAMED
- Basic UDI-DI
- B-06974969980502 EUDAMED
- EMDN Code
- W0105090501 CORONAVIRUS ANTIGEN (AG) - 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
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
Biobase COVID-19 Antigen Rapid Test by Biobase Diagnostic Technology (Shandong) 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-06974969980502 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 6c4254b9-97cf-423c-8523-a8d30b8652fb 61 fields · synced Oct 6, 2026