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Orthodontic Wax

by GNI Co., Ltd South Korea EUDAMED

Ref SOW-01

EMDN Q010499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000476014PW Basic UDI-DIDate7 Aug 2026RegisteredStatusActive

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
SOW-01
Primary DI / UDI-DI
08800046045759
Basic UDI-DI
88000476014PW
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class I
Market of Registration
Spain

Manufacturer details

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

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 (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 08800046045759|88000476014PW 61 fields · synced 24 Oct 2026