Auto Coagulation Analyzer
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 10 variants
Ref CX-6010Model CX-6000、CX-6010、CX-6200、CX-6210
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 | Number69449040AB320000128 06903053043052 | Date2 Jun 2023 | 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- Withdrawn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
- Model / Reference
- CX-6000、CX-6010、CX-6200、CX-6210, CX-6010
- Primary DI / UDI-DI
- 06903053043052
- Basic UDI-DI
- 69449040AB320000128
- EMDN Code
- W0202020102 Automated coagulometers
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →
Properties
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