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Solsius SelfCare Insole

by Solsius SAS France EUDAMED

Ref INSOLE-T2-R

EMDN Z12062602

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3760430740001VP Basic UDI-DIDate7 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Solsius SelfCare Insole
Model / Reference
INSOLE-T2-R
Primary DI / UDI-DI
03760430740095
Basic UDI-DI
3760430740001VP
EMDN Code
Z12062602 Sensor-based insoles
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000041700

Other devices from Solsius SAS

See all devices from Solsius SAS →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 64c1903c-7aff-4d7a-a839-75d952e8b3d8 61 fields · synced 22 Oct 2026