Complement C4 Kit (Turbidimetry Method)
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-004604-00Model 105-000840-00、105-000879-00、105-004604-00
EMDN W0102010205
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number694490400044C4*********4G | Date19 Sep 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 105-000840-00、105-000879-00、105-004604-00, 105-004604-00
- Primary DI / UDI-DI
- 06944904050829
- Basic UDI-DI
- 694490400044C4*********4G
- EMDN Code
- W0102010205 Complement component c4
- Device Class
- Class B
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED e5630442-8025-45f4-baf4-dac0f074be7e