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Formthotics

by Foot Science International Limited New Zealand EUDAMED

Ref FM06-OrShA-Re-ME EMDN Y061203

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number941943000001C2 Basic UDI-DIDate19 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Formthotics Foot Orthotic Insole
Model / Reference
FM06-OrShA-Re-ME
Primary DI / UDI-DI
09419430015880
Basic UDI-DI
941943000001C2
EMDN Code
Y061203 Orthoses, foot (including insoles and inserts)
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
NZ-MF-000044443
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Foot Science International Limited

See all devices from Foot Science International Limited →

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 65bb9a70-4678-4c1e-a2b6-d5955380796a 61 fields · synced 25 Oct 2026