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EZER Flu & COVID-19 Antigen Duo Rapid Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref P213107Ref P211146Ref P211137Ref P213106Ref P213109
Identity
- Trade Name
- EZER Flu & COVID-19 Antigen Duo Rapid Test EUDAMEDFlu & COVID-19 Antigen Duo Rapid Test EUDAMED
- Device Name
- EZER Flu & COVID-19 Antigen Duo Rapid Test EUDAMEDFlu & COVID-19 Antigen Duo Rapid Test EUDAMED
- Model / Reference
- P213107 EUDAMEDP211146 EUDAMEDP211137 EUDAMEDP213106 EUDAMEDP213109 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972698600811 EUDAMED16972698604277 EUDAMED16972698600606 EUDAMED16972698600804 EUDAMED16972698600828 EUDAMED
- Basic UDI-DI
- B-16972698600811 EUDAMEDB-16972698604277 EUDAMEDB-16972698600606 EUDAMEDB-16972698600804 EUDAMEDB-16972698600828 EUDAMED
- EMDN Code
- W0105070599 MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER EUDAMEDW0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDSpain EUDAMEDGreece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMEDEUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
EZER Flu & COVID-19 Antigen Duo Rapid Test by Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in…
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-16972698600811 | Class IVD devices for self-testing | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000013495
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED d423b062-66a0-4c00-aa21-e6be8ed4e754 61 fields · synced Oct 6, 2026
- EUDAMED f72612c4-bb21-446e-96c2-fb7f17726f1d 61 fields · synced May 16, 2026
- EUDAMED 54dcc836-3a41-4745-bf5c-6cb3ad267deb 61 fields · synced May 17, 2026
- EUDAMED 16ecf4ea-da01-46b5-aee2-70b0c8eb84b8 61 fields · synced May 18, 2026
- EUDAMED 8b7b24cc-6e02-4dc8-8d00-6f4bf60178a8 61 fields · synced May 18, 2026