Identity
- Trade Name
- SARS-CoV-2 Antigen Rapid Test EUDAMED
- Device Name
- SARS-CoV-2 Antigen Rapid Test EUDAMED
- Model / Reference
- BT0200201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260208753 EUDAMED
- Basic UDI-DI
- B-06933260208753 EUDAMED
- EMDN Code
- W0105040619,W0105040699 EUDAMEDW0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2 Antigen Rapid Test by Xiamen Biotime Biotechnology 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-06933260208753 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 114426db-5dd9-470d-8b34-f58646f8b0ab 61 fields · synced Oct 6, 2026
- EUDAMED 0fcd3fad-98c2-4c93-887c-f2e8d1ed9c96 61 fields · synced Jul 28, 2026