Automatic Hematology Analyzer
by Shenzhen Comen Medical Instruments Co., LTD. EUDAMED
Active
Ref CH8302, CH8602CRP, CH8500CRP, CH8502CRP, CH8600, CH8312, CH8602, CH8300CRP, CH8300, CH8601, CH8301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06945429026283 | Date22 Aug 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- CH8302, CH8602CRP, CH8500CRP, CH8502CRP, CH8600, CH8312, CH8602, CH8300CRP, CH8300, CH8601, CH8301
- Primary DI / UDI-DI
- 06945429026283, 06945429026023, 06945429026238, 06945429026252, 06945429026030, 06945429026313, 06945429026054, 06945429026320, 06945429026269, 06945429026047, 06945429026276
- Basic UDI-DI
- B-06945429026283, B-06945429026023, B-06945429026238, B-06945429026252, B-06945429026030, B-06945429026313, B-06945429026054, B-06945429026320, B-06945429026269, B-06945429026047, B-06945429026276
- EMDN Code
- W0102069006, W0202010101
- Device Class
- Class IVD General
- Market of Registration
- IcelandIreland
Manufacturer details
- EUDAMED SRN
- CN-MF-000002236
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Shenzhen Comen Medical Instruments Co., LTD.
See all devices from Shenzhen Comen Medical Instruments 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
- Professional Testing: No
- Companion Diagnostics: No