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COVID-19 (SARS-CoV-2) Antigen Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref W-Ag09-B20Model Type:B-20,20 Tests/kit (Positive and negative controls)
Identity
- Trade Name
- COVID-19 (SARS-CoV-2) Antigen Test Kit EUDAMED
- Model / Reference
- Type:B-20,20 Tests/kit (Positive and negative controls) EUDAMEDW-Ag09-B20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896416479 EUDAMED
- Basic UDI-DI
- B-06978896416479 EUDAMED
- EMDN Code
- W0105041101 CORONAVIRUS AG 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
COVID-19 (SARS-CoV-2) Antigen Test Kit by Wuhan Easydiagnosis Biomedicine 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-06978896416479 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- OSMUNDA Medical Technology Service GmbH DE-AR-000009285
Sources (1)
- EUDAMED eeb314fd-23d9-4961-b5ef-7a988ab43063 61 fields · synced Oct 5, 2026