Chemiluminescence Immunoassay Analyzer
by Shenzhen Increcare Biotech Co., Ltd China EUDAMED
Ref GS1Model Shine i1920 EMDN W0201020102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697514017Shinei1920GZ | Date19 Feb 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- Shine i1920, GS1
- Primary DI / UDI-DI
- 06975140170644
- Basic UDI-DI
- 697514017Shinei1920GZ
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000027299
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Increcare Biotech Co., Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED 18c1926c-af86-4915-8fdd-bb00d92bf4fe