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Medical LED light source

by GUANGXI VISUALTECH S&T Co., LTD. China EUDAMED

Ref ZLED-85001AModel ZLED-85001A、ZLED-60001A

EMDN Z129004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698008798001M9 Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
ZLED-85001A、ZLED-60001A, ZLED-85001A
Primary DI / UDI-DI
06980087980065
Basic UDI-DI
698008798001M9
Direct Marketing DI
06980087980065
EMDN Code
Z129004 Light sources
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000054392
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from GUANGXI VISUALTECH S&T Co., LTD.

See all devices from GUANGXI VISUALTECH S&T Co., LTD. →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
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

Sources (1)

  • EUDAMED fad80d1f-9e71-4a7f-85fd-7f141fce0fae 61 fields · synced 25 Oct 2026