Skip to content

Foot & Gait Medical

by XSENSOR Technology Corporation

Ref 813287000058

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 Number81328700SYS-00-00005-00MJ Basic UDI-DI 00813287000058UDI-DIDate21 Aug 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  • Withdrawn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

Model / Reference
813287000058
Primary DI / UDI-DI
00813287000058
Basic UDI-DI
81328700SYS-00-00005-00MJ
Direct Marketing DI
00813287000058
EMDN Code
Z12040199 General medicine diagnosis and monitoring instruments - other
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CA-MF-000053957
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Xsensor Technology 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