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Orthodontic Ceramic Bracket

by GNI Co., Ltd South Korea EUDAMED

Ref RCM-22-11

EMDN Q010403

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800046021746 Basic UDI-DIDate2 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
RCM-22-11
Primary DI / UDI-DI
08800046021746
Basic UDI-DI
B-08800046021746
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000031792
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Related devices

Category: Orthodontic tube

Other devices from GNI Co., Ltd

See all devices from GNI Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 20e03067-d15b-4159-8596-9a4a368674e5 61 fields · synced 23 Oct 2026