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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 D00001, F00001, ARGOS CAM-4000CModel 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, 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, ARGOS CAM-4000C, ARGOS CAM-4000D, ARGOS CAM-4000E, ARGOS CAM-4000F

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697715209D00001Z8 Basic UDI-DIDate9 Sep 2024RegisteredStatusActive

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  • Withdrawn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/Multi-purpose integrated endoscopic camera system
4K medical endoscope camera system
Model / Reference
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, D00001, 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, F00001, ARGOS CAM-4000C, ARGOS CAM-4000D, ARGOS CAM-4000E, ARGOS CAM-4000F
Primary DI / UDI-DI
16977152091037, 16977152092119, 06976648890027
Basic UDI-DI
697715209D00001Z8, 697715209F0000125, 697664889ARGOSCAMXH
Direct Marketing DI
16977152091037
16977152092119
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

Manufacturer details

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

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Properties

  • Reprocessed YesEUDAMEDNoEUDAMED

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