Rapid SARS-CoV-2 Antigen Test Card
by Xiamen Boson Biotech Co., Ltd. FDA registration: China EUDAMED
Ref 1N40C5-9 EMDN W0105090501
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberV76 061317 0012 | Date28 May 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- V76 061317 0012 Issued
Technical documentation EU IVDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 28 May 2025
- Expires
- 27 May 2030
Specification
- Model / Reference
- 1N40C5-9
- Primary DI / UDI-DI
- 06921963723154, 06921963723123, 06921963723062, 06921963723246, 06921963723031, 06921963723185, 06921963723093, 06921963723000
- Basic UDI-DI
- 692196371531J2
- Direct Marketing DI
- 0692196372315406921963723123069219637230620692196372324606921963723031069219637231850692196372309306921963723000
- EMDN Code
- W0105090501 Coronavirus antigen (ag) - rt & poc
- Device Class
- Class C
- Market of Registration
- Croatia
Manufacturer details
- EUDAMED SRN
- CN-MF-000001096
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Xiamen Boson Biotech Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (8)
- EUDAMED cfcaa039-e332-49e3-9308-14f411a352e8
- EUDAMED 06921963723123|692196371531J2
- EUDAMED 06921963723062|692196371531J2
- EUDAMED 06921963723246|692196371531J2
- EUDAMED 06921963723031|692196371531J2
- EUDAMED 06921963723185|692196371531J2
- EUDAMED 06921963723093|692196371531J2
- EUDAMED 06921963723000|692196371531J2