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Insole

by Shenzhen Kangdingnuo Tech Co, .Ltd

Ref KDN-F01Model KDN-F01，KDN-H01，KDN-H02，KDN-H03，KDN-H04，KDN-H05，KDN-H06，KDN-H07，KDN-H08，KDN-H09，KDN-H10，KDN-H11，KDN-H12，KDN-H13，KDN-H14，KDN-H15，KDN-H16，KDN-H17，KDN-H18，KDN-H19，KDN-H20，KDN-H21，KDN-I09

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698030492InsoleEJ Basic UDI-DI 06980304920010UDI-DIDate22 Jul 2026RegisteredStatusActive

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  • Withdrawn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
Insole
Model / Reference
KDN-F01，KDN-H01，KDN-H02，KDN-H03，KDN-H04，KDN-H05，KDN-H06，KDN-H07，KDN-H08，KDN-H09，KDN-H10，KDN-H11，KDN-H12，KDN-H13，KDN-H14，KDN-H15，KDN-H16，KDN-H17，KDN-H18，KDN-H19，KDN-H20，KDN-H21，KDN-I09, KDN-F01
Primary DI / UDI-DI
06980304920010
Basic UDI-DI
698030492InsoleEJ
EMDN Code
Y061203 Orthoses, foot (including insoles and inserts)
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000057062
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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