Automatic 5-part Hematology Analyzer
by Shenzhen YC Biotechnology Co., Ltd. EUDAMED
Active
Ref HC-5000
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06978741670001 | Date2 Jun 2025 | 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- Withdrawn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
- Device Name
- Automatic 5-part Hematology Analyzer
- Model / Reference
- HC-5000
- Primary DI / UDI-DI
- 06978741670001
- Basic UDI-DI
- B-06978741670001
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
- Device Class
- Class IVD General
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000048035
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen YC Biotechnology Co., Ltd.
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