Gastrin-17 Calibrators
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-029893-00Model 105-029891-00、105-029892-00 EMDN W0102152208
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040AB74000375T | Date17 Dec 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Gastrin-17 (CLIA)
- Model / Reference
- 105-029891-00、105-029892-00, 105-029893-00
- Primary DI / UDI-DI
- 06903053061018
- Basic UDI-DI
- 69449040AB74000375T
- Direct Marketing DI
- 06903053061018
- EMDN Code
- W0102152208 Standards and calibrators for individual and specific hormones /proteins
- 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
Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →
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 6c8b372c-9360-427e-8389-281da9b420d2