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Face Mask

by GNI Co., Ltd South Korea EUDAMED

Ref OFH091-01

EMDN Q010401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000476013PU Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
OFH091-01
Primary DI / UDI-DI
08800046046572
Basic UDI-DI
88000476013PU
EMDN Code
Q010401 Orthodontic face bows
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 a03c086a-697f-46d5-8691-8c8104fb85cb 61 fields · synced 22 Oct 2026