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EZER COVID-19 Antigen Rapid Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref P213108Ref P213105
Identity
- Trade Name
- EZER COVID-19 Antigen Rapid Test EUDAMED
- Device Name
- EZER COVID-19 Antigen Rapid Test EUDAMED
- Model / Reference
- P213108 EUDAMEDP213105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972698600866 EUDAMED16972698600798 EUDAMED
- Basic UDI-DI
- B-16972698600866 EUDAMEDB-16972698600798 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Netherlands 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
EZER COVID-19 Antigen Rapid Test by Hangzhou Genesis Biodetection and Biocontrol 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-16972698600866 | Class IVD devices for self-testing | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000013495
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 89e6ec42-b001-45a5-ac2f-5cb1d2d6b143 61 fields · synced Oct 6, 2026
- EUDAMED 63d6a9f7-2778-4275-87f6-d56c8b450bba 61 fields · synced May 19, 2026