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Sleeve Holder

by Osseointegration International Pty Ltd

Ref OPL-UTK-SH

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number93563710OPL-UTKY4 Basic UDI-DI 09356371012243UDI-DIDate7 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Universal Toolkit
Model / Reference
OPL-UTK-SH
Primary DI / UDI-DI
09356371012243
Basic UDI-DI
93563710OPL-UTKY4
Direct Marketing DI
09356371012243
EMDN Code
Y061280 Lower limb orthoses - accessories
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
AU-MF-000014557
Authorised representative
Easy Medical Device CommV BE-AR-000011902

Other devices from Osseointegration International Pty Ltd

See all devices from Osseointegration International Pty Ltd →

Properties

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