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Medical Endoscope Camera System/4K Medical Endoscope Camera System/Medical LED cold light Source

by Shenzhen Tuyou Medical Imaging Co., Ltd. EUDAMED

Active European Union

Ref A00003, A00004, F00002, F00006Model TV-LSD101B、TV-LSD101A、TV-LSH101B、TV-LSH101A、TV-D101A 、TV-D101B、TV-LS101G, TU-32LSD1A、TU-32LSD1B、TU-32LSD1E、TU-32LSD9H、TU-32LSD1F、TU-LSD100A、TU-LSD100B、TU-LSH100A、TU-LSD100C、TU-FLT461-03B、TU-FLT461-03R、TU-13D1F、TU-13D1R、TU-LSH100B、TU-D100A、TU-LSH100A、TU-Y3HDS、, 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, TU-Y4HDSC、TU-Y5D100B、TU-4KHDMI、TU-Y3HDS、TU-1080PHDMI、TU-Y2HC、TU-1080PUSB、TU-27LSD1A、TU-27LSD2B、TU-27LSH1A、TU-27LSH2B、TU-15LSD2F、TU-15LSD1F、TU-15LSD2C、TU-15LSD1D、TU-15LSD1C、TU-15LSD1B、TU-15LSD1A、TS-LS802TG, TU-27DIS1B、TU-27DIS1A、TU-32DIS1A、TU-12D1F、TU-Y4SHDCTU-VC01A、TU-GY100A、TU-4KOU-F、TU-LS102UG、TU-LS101BG, TS-LSD802TB、TS-LSD802TA、TS-D802TB、TS-D802TA、TV-LS801TG、TV-LSD801TB、TV-LSD801TA、TV-D801TB、TV-D801TA、TU-LS80TG、TU-LSD80TB、TU-LSD80TA、TU-D80TB、TU-D80TA、TS-LS902TG、TS-LSD902TB

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697715209009KY Basic UDI-DIDate19 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Medical Endoscope Camera System/4K Medical Endoscope Camera System/Medical LED cold light Source
Medical Endoscope Camera System/4K Medical Endoscope Camera System/Medical LED cold light Source/Multi-purpose integrated endoscopic camera system
Model / Reference
TV-LSD101B、TV-LSD101A、TV-LSH101B、TV-LSH101A、TV-D101A 、TV-D101B、TV-LS101G, A00003, TU-32LSD1A、TU-32LSD1B、TU-32LSD1E、TU-32LSD9H、TU-32LSD1F、TU-LSD100A、TU-LSD100B、TU-LSH100A、TU-LSD100C、TU-FLT461-03B、TU-FLT461-03R、TU-13D1F、TU-13D1R、TU-LSH100B、TU-D100A、TU-LSH100A、TU-Y3HDS、, A00004, 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, TU-Y4HDSC、TU-Y5D100B、TU-4KHDMI、TU-Y3HDS、TU-1080PHDMI、TU-Y2HC、TU-1080PUSB、TU-27LSD1A、TU-27LSD2B、TU-27LSH1A、TU-27LSH2B、TU-15LSD2F、TU-15LSD1F、TU-15LSD2C、TU-15LSD1D、TU-15LSD1C、TU-15LSD1B、TU-15LSD1A、TS-LS802TG, F00002, TU-27DIS1B、TU-27DIS1A、TU-32DIS1A、TU-12D1F、TU-Y4SHDCTU-VC01A、TU-GY100A、TU-4KOU-F、TU-LS102UG、TU-LS101BG, F00006, TS-LSD802TB、TS-LSD802TA、TS-D802TB、TS-D802TA、TV-LS801TG、TV-LSD801TB、TV-LSD801TA、TV-D801TB、TV-D801TA、TU-LS80TG、TU-LSD80TB、TU-LSD80TA、TU-D80TB、TU-D80TA、TS-LS902TG、TS-LSD902TB
Primary DI / UDI-DI
06977152090095, 06977152095533, 06977152090026, 06977152090040, 06977152090071, 06977152090033
Basic UDI-DI
697715209009KY, 697715209E00001ZM, 697715209002KJ, 697715209004KN, 697715209007KU, 697715209003KL
Direct Marketing DI
06977152090095
06977152095533
06977152090026
06977152090040
06977152090071
06977152090033
EMDN Code
Z12020401 Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images
Device Class
Class I
Market of Registration
Germany
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000043790
Authorised representative
WISELINK MEDICAL, S.L.U. ES-AR-000052118

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Properties

  • Reusable NoEUDAMEDYesEUDAMED

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