D-Dimer Calibrator
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-002300-00Model 105-012738-00、105-002236-00、105-002237-00、105-012737-00、105-004497-00、105-004498-00、105-002300-00、105-002301-00
EMDN W0102152299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040004JD-Dimer****Q7 | Date20 Sep 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- D-Dimer kit (Particle-enhanced Immunoturbidimetric Assay Method)、D-Dimer Calibrator、D-Dimer Control
- Model / Reference
- 105-012738-00、105-002236-00、105-002237-00、105-012737-00、105-004497-00、105-004498-00、105-002300-00、105-002301-00, 105-002300-00
- Primary DI / UDI-DI
- 06944904032283
- Basic UDI-DI
- 69449040004JD-Dimer****Q7
- EMDN Code
- W0102152299 Standards and calibrators - immunochemistry - other
- 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 6ec94243-7424-44b4-9193-958fb1d3b6bb