Chemiluminescence Immunoassay Analyzer
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref CL-2000iModel Please see UDI-DI for detail EMDN W0201020102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040MYYQ-BM10******9M | Date25 May 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- Please see UDI-DI for detail, CL-2000i
- Primary DI / UDI-DI
- 06944904047591
- Basic UDI-DI
- 69449040MYYQ-BM10******9M
- 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-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 (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 b91774b7-adc5-4902-aacf-6e62d9e3ce6f