One chip endoscope camera system
by Shenyang Shenda Endoscope Co., Ltd. China EUDAMED
Ref SD-4K-PModel SD-4K-PA
EMDN Z12020401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697124421CS00054C | Date27 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- One chip endoscope camera system
- Model / Reference
- SD-4K-PA, SD-4K-P
- Primary DI / UDI-DI
- 06971244215021
- Basic UDI-DI
- 697124421CS00054C
- EMDN Code
- Z12020401 Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000030478
- Authorised representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Other devices from Shenyang Shenda Endoscope Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: 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 06971244215021|697124421CS00054C