Medical Endoscope Camera System, 4K Medical Endoscope Camera System, Medical LED cold light Source
by Shenzhen Tuyou Medical Imaging Co., Ltd. 2 variants
Ref G00001Model TS-LSD902TA、TS-D902TB、TS-D902TA、TV-LSD901TB、TV-LSD901TA、TV-D901TB、TV-D901TA、TU-LS90TG、TU-LSD90TB、TU-LSD90TA、TU-D90TB、TU-D90TA、TV-LS104G、TV-LSH104B、TV-LSH104A
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697715209G000012J 16977152091051 | Date9 Sep 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Medical Endoscope Camera System/4K Medical Endoscope Camera System/Medical LED cold light Source/Multi-purpose integrated endoscopic camera system
- Model / Reference
- TS-LSD902TA、TS-D902TB、TS-D902TA、TV-LSD901TB、TV-LSD901TA、TV-D901TB、TV-D901TA、TU-LS90TG、TU-LSD90TB、TU-LSD90TA、TU-D90TB、TU-D90TA、TV-LS104G、TV-LSH104B、TV-LSH104A, G00001
- Primary DI / UDI-DI
- 16977152091051
- Basic UDI-DI
- 697715209G000012J
- Direct Marketing DI
- 16977152091051
- EMDN Code
- Z12020401 Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000043790
- Authorised representative
- WISELINK MEDICAL, S.L.U. ES-AR-000052118
Other devices from Shenzhen Tuyou Medical Imaging Co., Ltd.
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Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: 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