β-HB Control
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-002320-00Model 105-006184-00、105-004513-00、105-004514-00、105-002319-00、105-002320-00
EMDN W0101050201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040004JB-HB*******Q2 | Date20 Jul 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- β-Hydroxybutyrate Kit (Enzymatic Colorimetric Method)、β-HB Calibrator、β-HB Control
- Model / Reference
- 105-006184-00、105-004513-00、105-004514-00、105-002319-00、105-002320-00, 105-002320-00
- Primary DI / UDI-DI
- 06944904032382
- Basic UDI-DI
- 69449040004JB-HB*******Q2
- EMDN Code
- W0101050201 Enzyme controls
- 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 d1e6b446-6654-4d81-a6f8-f63a7efe0105