Skip to content

Medical Shoes

by Medtec International Sdn Bhd

Ref MD-WC001(OPEN TOE WOUND CARE SHOES)Model MD-WC001(OPEN TOE WOUND CARE SHOES), MD-WC002(OPEN TOE WOUND CARE SHOES), MD-WC003(OPEN TOE SOFT WOUND CARE SHOES), MD-WC004(OPEN TOE LOW OUTSOLE WOUND CARE SHOES), MD-WC005(CLOSED WOUND CARE SHOES), MD-WC006(ALL ROUND WOUND CARE SHOES),

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 Number955102435MEDTECMSWJ Basic UDI-DI 09551024350004UDI-DIDate7 May 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  • Withdrawn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
Medical Shoes
Model / Reference
MD-WC001(OPEN TOE WOUND CARE SHOES), MD-WC002(OPEN TOE WOUND CARE SHOES), MD-WC003(OPEN TOE SOFT WOUND CARE SHOES), MD-WC004(OPEN TOE LOW OUTSOLE WOUND CARE SHOES), MD-WC005(CLOSED WOUND CARE SHOES), MD-WC006(ALL ROUND WOUND CARE SHOES)
Primary DI / UDI-DI
09551024350004
Basic UDI-DI
955102435MEDTECMSWJ
EMDN Code
Y063303 Ready-made orthotic shoes
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
MY-MF-000041112
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Medtec International Sdn Bhd

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