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Diabetic Protect

by Medtec International Sdn Bhd

Ref MD-DBIS-017Model MD-DBIS001(HEXAGON CUT OFF LOADING SHOE INSOLE), MD-DBIS002(WOUND CARE SHOE INSOLE)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955102435MEDTECMIVW Basic UDI-DI 09551024350455UDI-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  • Withdrawn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 Insoles
Model / Reference
MD-DBIS001(HEXAGON CUT OFF LOADING SHOE INSOLE), MD-DBIS002(WOUND CARE SHOE INSOLE), MD-DBIS-017
Primary DI / UDI-DI
09551024350455
Basic UDI-DI
955102435MEDTECMIVW
EMDN Code
Y061203 Orthoses, foot (including insoles and inserts)
Device Class
Class I
EU market of registration
Slovakia

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