Total-P1NP/Osteocalcin/β-CTx Multi Control
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-045127-00Model 105-045127-00、105-045128-00、105-045130-00 、105-045129-00 EMDN W0102050106
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040AB74000645W | Date24 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 105-045127-00、105-045128-00、105-045130-00 、105-045129-00, 105-045127-00
- Primary DI / UDI-DI
- 06903053074148
- Basic UDI-DI
- 69449040AB74000645W
- EMDN Code
- W0102050106 Progesterone
- 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
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED eb557443-fc82-4858-80d1-84de5b768b8a