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surgical light

by Shandong Qufu Healthyou Medical Technology Co., Ltd EUDAMED

Active European Union

Ref KDLED500Model KDLED200,KDLED700,KDLED500,KDLED500/500，KDLED700/500,KDLED700/700,KDLED720/520，KDLED5/5，KDLED5/3，KDLED3/3，KDLED5，KDLED3，

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697893706KDLEDVD Basic UDI-DIDate28 Apr 2026RegisteredStatusActive

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  • Withdrawn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
surgical light
Model / Reference
KDLED200, KDLED700, KDLED500, KDLED500/500，KDLED700/500, KDLED700/700, KDLED720/520，KDLED5/5，KDLED5/3，KDLED3/3，KDLED5，KDLED3，
Primary DI / UDI-DI
06978937060470
Basic UDI-DI
697893706KDLEDVD
EMDN Code
Z12010701 Fixed scialytic lamps
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000023300
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Operating room light system

Other devices from Shandong Qufu Healthyou Medical Technology Co., Ltd

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: 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