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COVID-19 Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref ICOV5002-B001;ICOV5002-B005;ICOV5002-B025Model cassette
Identity
- Trade Name
- COVID-19 Antigen Rapid Test EUDAMED
- Device Name
- COVID-19 Antigen Rapid Test EUDAMED
- Model / Reference
- cassette EUDAMEDICOV5002-B001;ICOV5002-B005;ICOV5002-B025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ICOV05FD EUDAMED
- Basic UDI-DI
- B-ICOV05FD 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
Yes
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 Antigen Rapid Test by Hangzhou Clongene Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-ICOV05FD | Class IVD General | 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 582c210b-fd50-4a7e-b9d1-48badfaeb002 61 fields · synced Oct 7, 2026
- EUDAMED 582c210b-fd50-4a7e-b9d1-48badfaeb002-1 61 fields · synced Jun 10, 2026