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Kulzer Translux Cure

by Changzhou Sifary Medical Technology Co., Ltd. United States EUDAMED

Ref 6580009Model CuringPen, KIRA, Lumina Smart

EMDN Z12119099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697259778EL001M9 Basic UDI-DIDate15 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Dental Curing Light
Model / Reference
CuringPen, KIRA, Lumina Smart, 6580009
Primary DI / UDI-DI
06941877830519
Basic UDI-DI
697259778EL001M9
EMDN Code
Z12119099 Various dental stomatology instruments - other
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000010405
Authorised representative
Caretechion GmbH DE-AR-000005946

Other devices from Changzhou Sifary Medical Technology Co., Ltd.

See all devices from Changzhou Sifary Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 06941877830519|697259778EL001M9 61 fields · synced 25 Oct 2026