Insulin-like Growth Factor Binding Protein-3 Control
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-055570-00Model 105-049512-00、105-049511-00、105-055480-00、105-055481-00、105-055568-00、105-055569-00、105-055570-00、105-055571-00
EMDN W0102152008
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040AB740005863 | Date24 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Insulin-like Growth Factor Binding Protein-3 (CLIA)、Insulin-like Growth Factor Binding Protein-3 Control
- Model / Reference
- 105-049512-00、105-049511-00、105-055480-00、105-055481-00、105-055568-00、105-055569-00、105-055570-00、105-055571-00, 105-055570-00
- Primary DI / UDI-DI
- 06903053119962
- Basic UDI-DI
- 69449040AB740005863
- EMDN Code
- W0102152008 Controls for individual and specific hormones
- 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 (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 06903053119962|69449040AB740005863