Endoscope Camera (FULL HD Endoscope System; 4K Medical Endoscope Camera System)
by Xuzhou AKX Electronic Science and Technology co.，Ltd EUDAMED
Active
Ref YKD-9100AModel YKD-9001; YKD-9006; YKD-9007; YKD-9001E; YKD-9021; YKD-9100; YKD-9101; YKD-9102; YKD-9103; YKD-9107; YKD-9103E; YKD-9107E; YKD-9119; YKD-9122; YKD-9124 ;YKD-9132;YKD-9210;YKD-9211 ;YKD-9124H;YKD-9122H;YKD-9132H;YKD-9101H;YKD-9102T; YKD-9103T;YKD-9107T
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697378758SMNK9000SX | Date12 Dec 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Endoscope Camera (FULL HD Endoscope System; 4K Medical Endoscope Camera System)
- Model / Reference
- YKD-9001, YKD-9006, YKD-9007, YKD-9001E, YKD-9021, YKD-9100, YKD-9101, YKD-9102, YKD-9103, YKD-9107, YKD-9103E, YKD-9107E, YKD-9119, YKD-9122, YKD-9124, YKD-9132, YKD-9210, YKD-9211, YKD-9124H, YKD-9122H, YKD-9132H, YKD-9101H, YKD-9102T, YKD-9103T, YKD-9107T, YKD-9100A
- Primary DI / UDI-DI
- 06973787581045
- Basic UDI-DI
- 697378758SMNK9000SX
- EMDN Code
- Z12020405 Surgical cameras
- Device Class
- Class I
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000031488
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
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