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S1

by Kunshan Aoshida Electric Technology Co., Ltd China EUDAMEDGUDID

Ref Scooter-S1Model S1/S2

Product code ITIEMDN Y122130

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697108640SCOOTER35 Basic UDI-DIDate13 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06971086400111 UDI-DIDate24 Nov 2017ListedStatusIn 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
S1 EUDAMED
Freedomchair GUDID
Generic Name
Electric-motor-driven wheelchair, occupant-controlled
Device Name
Scooter
Model / Ref / Catalog
S1/S2 EUDAMED
Scooter-S1 EUDAMED
S1 GUDID
Primary DI / UDI-DI
06971086400111
Basic UDI-DI
697108640SCOOTER35
510(k) Number
FDA Product Code
ITI
EMDN Code
Y122130 Disability mopeds, 3-wheeled
GMDN Term
Electric-motor-driven wheelchair, occupant-controlled
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
890.3860
Market of Registration
Austria
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
S1/S2
Scooter-S1
GUDID
S1
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000004204
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Kunshan Aoshida Electric Technology Co., Ltd

  • A16

    Class I
  • GT01

    Class I
  • A06

    Class I
  • A06L

    Class I
  • A09

    Class I
  • A13

    Class I

See all devices from Kunshan Aoshida Electric Technology Co., Ltd →

Properties & raw data

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

Sources (2)

  • EUDAMED c9f51a74-2806-4298-9a06-91a24343c7f9 61 fields · synced 22 Oct 2026
  • FDA UDI ab18c6ff-c602-436d-b0e2-1befca31eb74 35 fields · synced 30 May 2026