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Fractures Splint

by I-Ming Sanitary Materials Co., Ltd Taiwan EUDAMED

Ref OD-009

EMDN Y061299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4717237lowerlimbK8 Basic UDI-DIDate6 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Orthoses, Lower Extremity - Others
Model / Reference
OD-009
Primary DI / UDI-DI
04717237040797, 04717237040827, 04717237040810
Basic UDI-DI
4717237lowerlimbK8
Direct Marketing DI
04717237040797
04717237040827
04717237040810
EMDN Code
Y061299 Lower extremity orthoses - other
Device Class
Class I
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
TW-MF-000008612
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from I-Ming Sanitary Materials Co., Ltd

See all devices from I-Ming Sanitary Materials 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 (3)

  • EUDAMED 581e210a-f20e-49dc-9062-645d678b51e9 61 fields · synced 23 Oct 2026
  • EUDAMED 04717237040827|4717237LOWERLIMBK8 61 fields · synced 8 Oct 2026
  • EUDAMED 04717237040810|4717237LOWERLIMBK8 61 fields · synced 24 Oct 2026