S100 Calibrators
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-032009-00Model 105-032007-00、105-032005-00、105-032009-00、105-032020-00、105-032021-00、105-032024-00、105-032025-00
EMDN W0102152205
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040AB740004962 | Date2 Jan 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- S100 (CLIA) 、S100 Calibrators、S100 Control
- Model / Reference
- 105-032007-00、105-032005-00、105-032009-00、105-032020-00、105-032021-00、105-032024-00、105-032025-00, 105-032009-00
- Primary DI / UDI-DI
- 06903053096591
- Basic UDI-DI
- 69449040AB740004962
- EMDN Code
- W0102152205 Tumour marker standards and calibrators
- Device Class
- Class C
- 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 (7)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED f2dacbba-4889-4560-80cf-794994663b2e