Medical Endoscope Camera System/4K Medical Endoscope Camera System/Medical LED cold light Source/Multi-purpose integrated endoscopic camera system
by Shenzhen Tuyou Medical Imaging Co., Ltd. 2 variants
Ref F00003Model TU-4KC90ICG、TU-4KC91ICG、TU-4KC92ICG、TU-4KC93ICG、TU-4KC94ICG、TU-4KC95ICG、TU-LTD500KTU-LT400G、TU-LTD300K、TU-LTD300K、TU-LTD300K、TU-LTD200F、TU-LS93、TU-LS92、TU-LS91、TU-LS90、TU-4KC96ICG、TU-LTD200F
Active
CE MDR
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 | Number697715209005KQ 06977152090057 | 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- Withdrawn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
- Medical Endoscope Camera System/4K Medical Endoscope Camera System/Medical LED cold light Source/Multi-purpose integrated endoscopic camera system
- Model / Reference
- TU-4KC90ICG、TU-4KC91ICG、TU-4KC92ICG、TU-4KC93ICG、TU-4KC94ICG、TU-4KC95ICG、TU-LTD500KTU-LT400G、TU-LTD300K、TU-LTD300K、TU-LTD300K、TU-LTD200F、TU-LS93、TU-LS92、TU-LS91、TU-LS90、TU-4KC96ICG、TU-LTD200F, F00003
- Primary DI / UDI-DI
- 06977152090057
- Basic UDI-DI
- 697715209005KQ
- Direct Marketing DI
- 06977152090057
- 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
- 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