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Silicone Heel Cushions

by OPPO Medical Corp. 4 variants

Ref 5454-N3-1, 5454-N4-1, 5451-N4-1, 5454-N1-1, 5454-N2-1

Active European Union

CE MDR

Valid until

No date given

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 Number471986369CL107DR Basic UDI-DI Date25 Nov 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  • Withdrawn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

Device name
Foot Orthoses
Model / reference
5454-N3-1, 5454-N4-1, 5451-N4-1, 5454-N1-1, 5454-N2-1
Primary DI / UDI-DI
04719863696010, 04711769156490, 04711769156483, 04719863695990, 04719863696003
Basic UDI-DI
471986369CL107DR
EMDN code
Y061203 Orthoses, foot (including insoles and inserts)
Device class
Class I
EU registration type
Standard device
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
TW-MF-000005201
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Related devices

Category: Orthotic insole, prefabricated, non-antimicrobial

Other devices from OPPO Medical Corp.

See all devices from OPPO Medical Corp. →

Properties

Other properties (14)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No