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Support Belts

by Um Orthotics Private Limited India EUDAMED

Ref K-01 EMDN Y060399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89045128SBES Basic UDI-DIDate27 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  • Withdrawn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 22 Oct 2026

Device Name
Support Belts
Model / Reference
K-01
Primary DI / UDI-DI
08904512804588, 08904512804595, 08904512804601
Basic UDI-DI
89045128SBES
EMDN Code
Y060399 Spine orthoses - other
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 (3)

  • EUDAMED c055fec6-961f-484f-abba-b33fb326b484 61 fields · synced 22 Oct 2026
  • EUDAMED 08904512804595|89045128SBES 61 fields · synced 5 Oct 2026
  • EUDAMED 08904512804601|89045128SBES 61 fields · synced 6 Oct 2026