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Softpro

by Ongoing Care Solutions, Inc United States EUDAMED

Ref SP 406-0Model KNEE ORTHOSIS

EMDN Y061209

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0849214041065WW Basic UDI-DIDate5 Feb 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

Model / Reference
KNEE ORTHOSIS, SP 406-0
Primary DI / UDI-DI
00849214002994
Basic UDI-DI
0849214041065WW
EMDN Code
Y061209 Knee orthoses
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000048030
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Ongoing Care Solutions, Inc

See all devices from Ongoing Care Solutions, Inc →

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 (1)

  • EUDAMED 00b6641c-b58a-4a68-b26e-e634c985b913 61 fields · synced 22 Oct 2026