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Silicone Heel Cup

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

Ref OO-131 EMDN Y061203

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4717237insoleOOAQ 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  • Withdrawn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
Orthosis, Foot (including insoles and inserts)
Model / Reference
OO-131
Primary DI / UDI-DI
04717237014279, 04717237014286
Basic UDI-DI
4717237insoleOOAQ
Direct Marketing DI
04717237014279
04717237014286
EMDN Code
Y061203 Orthoses, foot (including insoles and inserts)
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 a1df9b95-5150-4412-a182-04f3d11b08b4 61 fields · synced 22 Oct 2026
  • EUDAMED 04717237014286|4717237INSOLEOOAQ 61 fields · synced 19 May 2026