Sample Processing System
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref SPL 2000, SPL 1000, CAL 8000, CAL 6000, CAL 7000, EU 8600 GTModel Please see UDI-DI for detail, CAL 8000、CAL 6000, CAL 9000, CAL 7000, CAL 7000E, EU 8600
EMDN W02060102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040SHYQ-LA20******UJ | Date25 May 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- Please see UDI-DI for detail, SPL 2000, SPL 1000, CAL 8000、CAL 6000, CAL 8000, CAL 6000, CAL 9000, CAL 7000, CAL 7000E, EU 8600, EU 8600 GT
- Primary DI / UDI-DI
- 06936415912239, 06936415911867, 06944904048550, 06936415912390, 06903053000345, 06903053039734, 06903053035729
- Basic UDI-DI
- 69449040SHYQ-LA20******UJ, 69449040SHYQ-LA10******TX, 69449040AB3000003ZF, 69449040AB3000025ZR, 69449040AB310000523
- EMDN Code
- W02060102 Automated sample transport systems
- 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 (7)
- EUDAMED 7e01b80b-c02a-4ab1-a7dd-d531690e4478
- EUDAMED 06936415911867|69449040SHYQ-LA10******TX
- EUDAMED 06944904048550|69449040AB3000003ZF
- EUDAMED 06936415912390|69449040AB3000003ZF
- EUDAMED 06903053000345|69449040AB3000025ZR
- EUDAMED 06903053039734|69449040AB310000523
- EUDAMED 06903053035729|69449040AB310000523