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Stealth Positioning i-Fit

by Stealth Products, LLC. United States EUDAMEDGUDID

Ref Stealth Positioning i-FitModel FIT

Product code KNOEMDN Y122406

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6065090060650990008*9LE Basic UDI-DIDate8 Jul 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00606509900089 UDI-DIDate26 Aug 2019ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
i-Fit
Generic Name
Wheelchair head/trunk support, prefabricated
Device Name
Stealth Positioning i-Fit
Model / Ref / Catalog
FIT EUDAMED
Stealth Positioning i-Fit EUDAMED
i-Fit GUDID
N/A GUDID
Primary DI / UDI-DI
00606509900089
Basic UDI-DI
6065090060650990008*9LE
FDA Product Code
KNO
EMDN Code
Y122406 Belts, seats and armrests for wheelchairs
GMDN Term
Wheelchair head/trunk support, prefabricated
Device Class
Class I
Regulation Number
890.3910
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
FIT
Stealth Positioning i-Fit
GUDID
i-Fit

Manufacturer details

EUDAMED SRN
US-MF-000018367
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Stealth Products, LLC.

See all devices from Stealth Products, LLC. →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Over-the-Counter
  • Premarket Exempt
  • Serial Number
Other properties (20)
  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED c5fb20e9-d29e-4060-b50a-e4450b3833a6 61 fields · synced 22 Oct 2026
  • FDA UDI 01ebb5ab-a2cc-4cf9-bcef-3b5c10baa77e 34 fields · synced 30 May 2026