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OPTIVOhand

by OPED GmbH Germany EUDAMED

Ref OPHA-01-1-S/M-CH EMDN Y060606

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4046618Y0606OHBV Basic UDI-DIDate3 Mar 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
OPTIVOhand
Model / Reference
OPHA-01-1-S/M-CH
Primary DI / UDI-DI
04046618155011
Basic UDI-DI
4046618Y0606OHBV
EMDN Code
Y060606 Hand orthoses
Device Class
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000008286

Other devices from OPED GmbH

See all devices from OPED GmbH →

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 04046618155011|4046618Y0606OHBV 61 fields · synced 24 Oct 2026