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Softpro

by Ongoing Care Solutions, Inc United States EUDAMED

Ref SP 31FG-YR(S)Model WRIST HAND FINGER ORTHOSIS

EMDN Y060613

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0849214041459XP 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
WRIST HAND FINGER ORTHOSIS, SP 31FG-YR(S)
Primary DI / UDI-DI
00849214004035
Basic UDI-DI
0849214041459XP
EMDN Code
Y060613 Wrist-hand-fingers 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 dbd895f2-766e-4223-840f-d59f4da67335 61 fields · synced 22 Oct 2026