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COVID-19 Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref ICOV-501Ref ICOV-802H
Identity
- Trade Name
- COVID-19 Antigen Rapid Test EUDAMED
- Device Name
- COVID-19 Antigen Rapid Test EUDAMED
- Model / Reference
- ICOV-501 EUDAMEDICOV-802H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983148801 EUDAMED06970277518277 EUDAMED06970277517980 EUDAMED
- Basic UDI-DI
- B-06936983148801 EUDAMEDB-06970277518277 EUDAMEDB-06970277517980 EUDAMED
- EMDN Code
- W0105040619,W0105099099 EUDAMEDW0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass IVD devices for self-testing EUDAMED
- Market of Registration
- Netherlands EUDAMEDIreland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMEDEUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
COVID-19 Antigen Rapid Test by Hangzhou Alltest 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-06936983148801 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED fdbc4db5-e080-4bd2-bbbd-39802a3acf3e 61 fields · synced Jul 20, 2026
- EUDAMED 3ccc0c59-57cc-4e62-aed6-e20e726732e6 61 fields · synced Jul 11, 2026
- EUDAMED 8045f85a-f480-45e6-99fb-c9a672fab098 61 fields · synced Jul 20, 2026