Skip to content

Fracture

by Um Orthotics Private Limited India EUDAMED

Ref C-09 EMDN Y060630

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  • Withdrawn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 23 Oct 2026

Device Name
Fracture
Model / Reference
C-09
Primary DI / UDI-DI
08904512801389, 08904512801372, 08904512801396, 08904512801402
Basic UDI-DI
89045128FADH
EMDN Code
Y060630 Shoulder-elbow-wrist- hand 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 0d387e69-c851-4056-80f0-394dc7fb1b10 61 fields · synced 23 Oct 2026
  • EUDAMED 08904512801372|89045128FADH 61 fields · synced 25 Jul 2026
  • EUDAMED 08904512801396|89045128FADH 61 fields · synced 29 Jul 2026
  • EUDAMED 08904512801402|89045128FADH 61 fields · synced 4 Aug 2026