Immunochromatography AI Reader
by Shenzhen Everbest Machinery lndustry Co., Ltd. China EUDAMED
Ref CV-200
EMDN W0201069099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number695111092014C9 | Date17 Dec 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Immunochromatography AI Reader
- Model / Reference
- CV-200
- Primary DI / UDI-DI
- 06951110920143
- Basic UDI-DI
- 695111092014C9
- Direct Marketing DI
- 06951110920143
- EMDN Code
- W0201069099 Various rapid test chemistry / immunochemistry instruments - other
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000008730
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED bc27f38a-ce75-4875-92f2-c55c8a50f855