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Rapid SARS-CoV-2 Antigen Test Card
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 1 test/package
Identity
- Device Name
- Rapid SARS-CoV-2 Antigen Test Card EUDAMED
- Model / Reference
- 1 test/package EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975146600008 EUDAMED
- Basic UDI-DI
- B-06975146600008 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Rapid SARS-CoV-2 Antigen Test Card by BioDetect（Xiamen）Biotechnology 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-06975146600008 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- BioDetect（Xiamen）Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000001098
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 76b92dcf-fbfc-4f55-b2fc-8329a6c0e8dd 61 fields · synced Jun 9, 2026