Endoscopic Image System
by Hunan Endoso Life Technology Co., Ltd United States EUDAMED
Ref U400-CModel U400、U400-A 、U400-B 、U400-C、U400-D 、U500 、U500-A 、U500-B
EMDN Z12020480
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697520277003J3 | Date1 Dec 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Endoscopic Image System
- Model / Reference
- U400、U400-A 、U400-B 、U400-C、U400-D 、U500 、U500-A 、U500-B, U400-C
- Primary DI / UDI-DI
- 06975202778917
- Basic UDI-DI
- 697520277003J3
- EMDN Code
- Z12020480 Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - hardware accessories
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000021400
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
Other devices from Hunan Endoso Life Technology Co., Ltd
See all devices from Hunan Endoso Life Technology 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 0b57c400-b042-4e78-93ef-5cdedc3b17ca