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COVID-19(SARS-CoV-2) Antigen Test Kit
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref W-AgH-07SModel Type:B-7 Tests/Kit Type S
Identity
- Trade Name
- COVID-19(SARS-CoV-2) Antigen Test Kit EUDAMED
- Device Name
- COVID-19(SARS-CoV-2) Antigen Test Kit EUDAMED
- Model / Reference
- Type:B-7 Tests/Kit Type S EUDAMEDW-AgH-07S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896417612 EUDAMED
- Basic UDI-DI
- B-06978896417612 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing 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
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
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 devices for self-testing — 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-06978896417612 | Class IVD devices for self-testing | 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 012ad5df-4e0e-4793-8bd0-f0012d15af81 61 fields · synced Jun 19, 2026