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bright Alone

by Dentium Co., Ltd. (ICT Branch) South Korea EUDAMED

Ref ICT-CH02

EMDN Z12110101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880946030Dental_ChairS2 Basic UDI-DIDate17 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
ICT-CH02
Primary DI / UDI-DI
08809544909990
Basic UDI-DI
880946030Dental_ChairS2
Direct Marketing DI
08809544909990
EMDN Code
Z12110101 Dental treatment units
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000034082
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Dentium Co., Ltd. (ICT Branch)

  • bright CT

    Class IIb

  • rainbow MCT

    Class II

  • Intraoral Sensor

    Class II

  • rainbow CT

    Class II

  • iCTmotor

    Class IIa

  • bright CT

    Class IIb

See all devices from Dentium Co., Ltd. (ICT Branch) →

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 cb625a8d-1436-422b-8a0f-40e9d2b65d50 61 fields · synced 24 Oct 2026