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iWALKFree Hands Free Crutch

by iWALKFree, Inc

Ref HFC30303

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number86000259081395 Basic UDI-DI 00860002590813UDI-DIDate30 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00860002590813 UDI-DI Date8 Mar 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
iWALKFree Hands Free Crutch EUDAMED
iWALK3.0, the iWALKFree 3.0 Hands Free Crutch GUDID
Generic Name
Single-side-support walking frame
Device Name
iWALKFree 3.0 Hands Free Crutch
Model / Reference
HFC30303
Primary DI / UDI-DI
00860002590813
Basic UDI-DI
86000259081395
FDA Product Code
IQI, IPR
EMDN Code
Y120399 Walking devices, one-handed operation - other
GMDN Term
Single-side-support walking frame
Device Class
Class I
Regulation Number
890.3475, 890.3150
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Manufacturer details

EUDAMED SRN
US-MF-000008192
Authorised representative
CEpartner4U NL-AR-000000111

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Serial Number

Other properties (20)

  • 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No