Cs-600B
by Dirui Industrial Co., Ltd 2 variants
Ref 3000085Model CS-600B CS-650 CS-680 CS-1200
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69257945W0201010102D0JL 06925794504647 | Date26 Oct 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Auto-Chemistry Analyzer
- Model / Reference
- CS-600B CS-650 CS-680 CS-1200, 3000085
- Primary DI / UDI-DI
- 06925794504647
- Basic UDI-DI
- 69257945W0201010102D0JL
- EMDN Code
- W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
- Device Class
- Class A
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000001891
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Dirui Industrial Co., Ltd
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- New Device: No