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Fracture

by Um Orthotics Private Limited India EUDAMED

Ref C-02

EMDN Y061217

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89045128FADH 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 22 Oct 2026

Device Name
Fracture
Model / Reference
C-02
Primary DI / UDI-DI
08904512805578, 08904512801044, 08904512805585, 08904512801037, 08904512805608, 08904512805677
Basic UDI-DI
89045128FADH
EMDN Code
Y061217 Thigh 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 (6)

  • EUDAMED 39aaabed-cee0-46f9-9b6c-7c9562b24e9a 61 fields · synced 22 Oct 2026
  • EUDAMED 08904512801044|89045128FADH 61 fields · synced 18 Jun 2026
  • EUDAMED 08904512805585|89045128FADH 61 fields · synced 18 Jun 2026
  • EUDAMED 08904512801037|89045128FADH 61 fields · synced 19 Jun 2026
  • EUDAMED 08904512805608|89045128FADH 61 fields · synced 19 Jun 2026
  • EUDAMED 08904512805677|89045128FADH 61 fields · synced 11 Jul 2026