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Heel Spur Cushion

by Welsheng Corp. 3 variants

Ref 334-B-1

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 23 Oct 2026. What this means

Overview

The Heel Spur Cushion is a medical device designed to provide relief from heel spurs, a common condition that can be caused by wear and tear on the joints in the foot. The cushion is filled with a soft material that conforms to the shape of the foot and provides pressure relief, reducing pain and discomfort.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471988489CL106GS Basic UDI-DI 04719884890916UDI-DIDate4 Sep 2023RegisteredStatusActive

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  • Withdrawn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 Cushion
Model / Reference
334-B-1
Primary DI / UDI-DI
04719884890916
Basic UDI-DI
471988489CL106GS
EMDN Code
Y061203 Orthoses, foot (including insoles and inserts)
Device Class
Class I
EU market of registration
Malta

Manufacturer details

EUDAMED SRN
TW-MF-000005197
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Welsheng Corp.

See all devices from Welsheng Corp. →

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