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Soles One Size Silicone Bunione Protector

by Tuna Dis Tic. Ve Paz. Ltd. Sti

Ref SOLES10Model Foot Ortheses

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number869891850KORUYUCUAT Basic UDI-DI 08698918503021UDI-DIDate26 Jul 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Foot Ortheses, SOLES10
Primary DI / UDI-DI
08698918503021
Basic UDI-DI
869891850KORUYUCUAT
Direct Marketing DI
08698918503021
EMDN Code
V0811 Heel, elbow and knee anti-decubitus protection aids
Device Class
Class I
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
TR-MF-000021856

Other devices from Tuna Dis Tic. Ve Paz. Ltd. Sti

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