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Fracture

by Um Orthotics Private Limited India EUDAMED

Ref C-03 EMDN Y06120601

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89045128FADH Basic UDI-DIDate26 May 2026RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Device Name
Fracture
Model / Reference
C-03
Primary DI / UDI-DI
08904512801105, 08904512801082, 08904512801112, 08904512801099
Basic UDI-DI
89045128FADH
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 (4)

  • EUDAMED f29d0275-e213-448b-9ec9-841fc21c000a 61 fields · synced 24 Oct 2026
  • EUDAMED 08904512801082|89045128FADH 61 fields · synced 21 Jul 2026
  • EUDAMED 08904512801112|89045128FADH 61 fields · synced 23 Jul 2026
  • EUDAMED 08904512801099|89045128FADH 61 fields · synced 25 Oct 2026