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Foot/Ankle

by Um Orthotics Private Limited India EUDAMED

Ref D-12

EMDN Y06120601

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89045128FNA24 Basic UDI-DIDate26 May 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

Device Name
Foot/Ankle
Model / Reference
D-12
Primary DI / UDI-DI
08904512801891, 08904512805615
Basic UDI-DI
89045128FNA24
EMDN Code
Y06120601 Passive ankle-foot orthoses
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
IN-MF-000045949
Authorised representative
Meddevices Lifesciences B.V. NL-AR-000000594

Other devices from Um Orthotics Private Limited

See all devices from Um Orthotics Private Limited →

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 0cb93eac-646a-42d4-b09b-2f078906dcaf 61 fields · synced 24 Oct 2026
  • EUDAMED 08904512805615|89045128FNA24 61 fields · synced 13 Jul 2026