UHD Imaging System for Endoscope
by GUANGXI VISUALTECH S&T Co., LTD. China EUDAMED
Ref Z4KF-30002AModel Z4KF-30002A、Z4KF-20002A;Z4KF-31001A、Z4KF-21001A；ZHDF-30001A, ZHDF-20001A EMDN Z12020703
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number698008798002MB | Date21 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- UHD Imaging System for Endoscope/ FHD Imaging System for Endoscope
- Model / Reference
- Z4KF-30002A、Z4KF-20002A, Z4KF-31001A、Z4KF-21001A；ZHDF-30001A, ZHDF-20001A, Z4KF-30002A
- Primary DI / UDI-DI
- 06980087980027
- Basic UDI-DI
- 698008798002MB
- Direct Marketing DI
- 06980087980027
- EMDN Code
- Z12020703 Colposcopes
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000054392
- Authorised representative
- Eunitor GmbH DE-AR-000005081
Other devices from GUANGXI VISUALTECH S&T Co., LTD.
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 7b2b46ff-9601-4cf4-be96-85ce7972f6f0