growth STimulation expressed gene 2 (CLIA)
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. EUDAMED
Active
Ref 105-038095-00Model 105-038094-00, 105-038095-00, 105-038096-00, 105-040606-00, 105-040605-00, 105-040608-00, 105-040607-00
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040AB74000515M | Date31 Dec 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- growth STimulation expressed gene 2 (CLIA), ST2 Calibrators, ST2 Control
- Model / Reference
- 105-038094-00, 105-038095-00, 105-038096-00, 105-040606-00, 105-040605-00, 105-040608-00, 105-040607-00
- Primary DI / UDI-DI
- 06903053046015
- Basic UDI-DI
- 69449040AB74000515M
- EMDN Code
- W01021314 St2
- 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
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No