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surgical light

by Shandong Qufu Healthyou Medical Technology Co., Ltd 29 variants

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

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697893706KDLEDVD Basic UDI-DI 06978937060500UDI-DIDate28 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

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,, KDLED700/500
Primary DI / UDI-DI
06978937060500
Basic UDI-DI
697893706KDLEDVD
EMDN Code
Z12010701 Fixed scialytic lamps
Device Class
Class I
EU market of registration
Austria

Manufacturer details

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

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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