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Night Splint

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

Ref OH-928 EMDN Y06120601

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4717237LIMBankle77 Basic UDI-DIDate6 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Orthoses, Ankle Foot
Model / Reference
OH-928
Primary DI / UDI-DI
04717237019281, 04717237014064
Basic UDI-DI
4717237LIMBankle77
Direct Marketing DI
04717237019281
04717237014064
EMDN Code
Y06120601 Passive ankle-foot orthoses
Device Class
Class I
Market of Registration
Spain

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 (2)

  • EUDAMED eee67dcd-7f08-4f78-9d51-f60aa2421280 61 fields · synced 22 Oct 2026
  • EUDAMED 04717237014064|4717237LIMBANKLE77 61 fields · synced 19 May 2026