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COVID-19 Antigen Rapid Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref ISCOVu002-A001; ISCOVu002-A005; ISCOVu002-A025; ISCOVu002-B001; ISCOVu002-B005; ISCOVu002-B025
Identity
- Trade Name
- COVID-19 Antigen Rapid Test EUDAMED
- Device Name
- COVID-19 Antigen Rapid Test EUDAMED
- Model / Reference
- ISCOVu002-A001; ISCOVu002-A005; ISCOVu002-A025; ISCOVu002-B001; ISCOVu002-B005; ISCOVu002-B025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ISCOVu005G EUDAMED
- Basic UDI-DI
- B-ISCOVu005G EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
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 Antigen Rapid Test by Hangzhou Clongene Biotech 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-ISCOVu005G | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Hangzhou Clongene Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000030069
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 1c54f7b2-0f69-4ae7-9e89-04daa0961acc 61 fields · synced Oct 6, 2026
- EUDAMED 1c54f7b2-0f69-4ae7-9e89-04daa0961acc-1 61 fields · synced Jun 10, 2026