Automatic Hematology Analyzer F-SC Cleaning Fluid
by Maccura Biotechnology Co., Ltd. China EUDAMED
Ref EBL2201026Model 10 mL×1; 10 mL×2; 20 mL×1; 20 mL×2 EMDN W0202010185
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69506174BL2200266Y | Date14 Mar 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 10 mL×1, 10 mL×2, 20 mL×1, 20 mL×2, EBL2201026
- Primary DI / UDI-DI
- 06950617415749
- Basic UDI-DI
- 69506174BL2200266Y
- Direct Marketing DI
- 06950617415749
- EMDN Code
- W0202010185 Automated whole blood hematology analysers - consumables
- Device Class
- Class A
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000014618
- Authorised representative
- Humiss International B.V. NL-AR-000001490
Other devices from Maccura Biotechnology Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 286c1c35-8e2f-46f2-865a-27fd7b158c0e