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Formthotics FM01-OrSpA-Cb-XS

by Foot Science International Limited

Ref FM01-OrSpA-Cb-XS

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number941943000001C2 Basic UDI-DI 09419430003450UDI-DIDate19 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number09419430003450 UDI-DI Date31 Jan 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Formthotics
Generic Name
Orthotic insole, prefabricated, antimicrobial
Device Name
Formthotics Foot Orthotic Insole
Model / Reference
FM01-OrSpA-Cb-XS
Primary DI / UDI-DI
09419430003450
Basic UDI-DI
941943000001C2
FDA Product Code
IQI
EMDN Code
Y061203 Orthoses, foot (including insoles and inserts)
GMDN Term
Orthotic insole, prefabricated, antimicrobial
Device Class
Class I
Regulation Number
890.3475
Market of Registration
Austria
GUDID distribution status
In Commercial Distribution

Other devices from Foot Science International Limited

See all devices from Foot Science International Limited →

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No