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Xtend Foot Fri H100 H100-429-STY-FCR

by C Lindhextend AB

Ref H100-429-STY-FCRModel H100

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07350104145170 UDI-DI Date15 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number735010414H100W4 Basic UDI-DI 07350104145170UDI-DIDate25 May 2026RegisteredStatusActive

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  • Withdrawn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
Xtend Foot Fri H100, Size 29, Weight max 80 kgs, Right Caucasian EUDAMED
Xtend Foot Fri H100 GUDID
Generic Name
Mechanical-resistance external ankle-foot prosthesis
Device Name
Xtend Foot H100
Model / Ref / Catalog
H100-429-STY-FCR, H100
Primary DI / UDI-DI
07350104145170
Basic UDI-DI
735010414H100W4
FDA Product Code
ISH
EMDN Code
Y062499 Lower extremity prostheses - other
GMDN Term
Mechanical-resistance external ankle-foot prosthesis
Device Class
Class I
Regulation Number
890.3420
EU market of registration
Norway
GUDID distribution status
In Commercial Distribution

Other devices from C Lindhextend AB

See all devices from C Lindhextend AB →

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No