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EVENup Höhenausgleichssohle

by OPED GmbH 17 variants

Ref AUSG-01-4-M-ENModel Höhenausgleichssohle, Höhenausgleichsschuh

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 Number4046618Y0633ASBF Basic UDI-DI 04046618174494UDI-DIDate18 Mar 2025RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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
EVENup
Model / Reference
Höhenausgleichssohle, Höhenausgleichsschuh, AUSG-01-4-M-EN
Primary DI / UDI-DI
04046618174494
Basic UDI-DI
4046618Y0633ASBF
EMDN Code
Y063303 Ready-made orthotic shoes
Device Class
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000008286

Other devices from OPED GmbH

See all devices from OPED GmbH →

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