BNP Calibrators
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-005911-00Model 105-005660-00、105-005677-00、105-005911-00, 105-005660-00/105-005677-00 EMDN W0102152204
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040004L-BNP*******5T | Date19 Sep 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- B-type natriuretic peptide(CLIA)、BNP CalibratorsB-type natriuretic peptide (CLIA)
- Model / Reference
- 105-005660-00、105-005677-00、105-005911-00, 105-005911-00, 105-005660-00/105-005677-00
- Primary DI / UDI-DI
- 06944904065465
- Basic UDI-DI
- 69449040004L-BNP*******5T, 69449040AB74000075J
- EMDN Code
- W0102152204 Cardiac 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 (6)
- Sterile: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (2)
- EUDAMED 640131de-a46b-4a21-bd54-48b37abaeb28
- EUDAMED 06944904065465|69449040AB74000075J