4K Medical Endoscope Camera System/Medical Endoscope Camera System/Medical LED cold light Source/Multi-purpose integrated endoscopic camera system
by Shenzhen Tuyou Medical Imaging Co., Ltd.
Ref F00001, D00001Model TU-24LSD1A,TU-24LSD1B,TU-24LSD1C,TU-24LSD1D,TU-24LSD1A,TU-24LSD1B,TU-24LSD1C,TU-24LSD1D,TU-24LSD1E,TU-24LSD9H, TU-24LSD1F,TU-LSH200H;TU-LSD101A,TU-LHS101A,TU-LSD10KB,TU-PY460T,TU-GY460T,TU-D101A,TU-D101B,TU-LSD101KA, TU-24LSD1A,TU-24LSD1B,TU-24LSD1C,TU-24LSD1D,TU-24LSD1A,TU-24LSD1B,TU-24LSD1C,TU-24LSD1D,TU-24LSD1E,TU-24LSD9H, TU-24LSD1F,TU-LSH200H;TU-LSD101B,TU-LHS101A,TU-LSD10KB,TU-PY460T,TU-GY460T,TU-D101A,TU-D101B,TU-LSD101KA
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697715209001KG | Date3 Mar 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Multi-purpose integrated endoscopic
- Model / Reference
- TU-24LSD1A,TU-24LSD1B,TU-24LSD1C,TU-24LSD1D,TU-24LSD1A,TU-24LSD1B,TU-24LSD1C,TU-24LSD1D,TU-24LSD1E,TU-24LSD9H, TU-24LSD1F,TU-LSH200H, TU-LSD101A,TU-LHS101A,TU-LSD10KB,TU-PY460T,TU-GY460T,TU-D101A,TU-D101B,TU-LSD101KA, F00001, TU-LSD101B,TU-LHS101A,TU-LSD10KB,TU-PY460T,TU-GY460T,TU-D101A,TU-D101B,TU-LSD101KA, D00001
- Primary DI / UDI-DI
- 06977152090019, 16977152091068
- Basic UDI-DI
- 697715209001KG, 697715209H000012X
- 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
- GermanyItaly
Manufacturer details
- EUDAMED SRN
- CN-MF-000043790
- Authorised representative
- WISELINK MEDICAL, S.L.U. ES-AR-000052118
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Properties
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