Hematology Analyzer
by Shenzhen Cinnaray Life Technology Co., Ltd. 11 variants
Ref XQY5200Model X3000, X3100, X5000, X5100, X5200, X5300, CF9600, CH8600CS, CH8600/CRP, CH8500/CRP, CH8300/CRP
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 | Number698002989XQYWA 06980029893217 | Date31 Aug 2026 | 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- Withdrawn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
- Hematology Analyzer
- Model / Reference
- X3000, X3100, X5000, X5100, X5200, X5300, CF9600, CH8600CS, CH8600/CRP, CH8500/CRP, CH8300/CRP, XQY5200
- Primary DI / UDI-DI
- 06980029893217
- Basic UDI-DI
- 698002989XQYWA
- Direct Marketing DI
- 06980029893217
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000057751
- Authorised representative
- HUMISS TRADING S. L. ES-AR-000040177
Other devices from Shenzhen Cinnaray Life Technology Co., Ltd.
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Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No