Chemiluminescence Immunoassay Analyzer
by Shenzhen Increcare Biotech Co., Ltd China EUDAMED
Ref Shine i6910 EMDN W0201020103
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697514017Shinei6910HZ | Date21 Jul 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- Shine i6910
- Primary DI / UDI-DI
- 06975140171146
- Basic UDI-DI
- 697514017Shinei6910HZ
- EMDN Code
- W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 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 (9)
- Sterile: No
- Human Tissues: 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 45e8ecf1-4241-436f-aeaf-8170e47dc779