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A08

by Kunshan Aoshida Electric Technology Co., Ltd China EUDAMEDGUDID

Ref DYW50-A08Model GT01/A16/A15L/A15/A13/D05/A12S/A12/A11/A10/DE09/A09/DE08L/A08L/DE08/A08/A07/A06L/A06/T3 Product code ITIEMDN Y122127

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697108640DYW50JF Basic UDI-DIDate13 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06971086400081 UDI-DIDate2 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 AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
A08 EUDAMED
Freedomchair GUDID
Generic Name
Electric-motor-driven wheelchair, occupant-controlled
Model / Ref / Catalog
GT01/A16/A15L/A15/A13/D05/A12S/A12/A11/A10/DE09/A09/DE08L/A08L/DE08/A08/A07/A06L/A06/T3, DYW50-A08, A08
Primary DI / UDI-DI
06971086400081
Basic UDI-DI
697108640DYW50JF
510(k) Number
FDA Product Code
ITI
EMDN Code
Y122127 Electric wheelchairs
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 · 1 field differs

FieldEUDAMEDGUDID
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

  • A15L

    Class I

  • A16

    Class I

  • GT01

    Class I

  • A06

    Class I

  • A06L

    Class I

  • A09

    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 422ba289-87c7-43b7-b99a-575dde7d9373 61 fields · synced 24 Oct 2026
  • FDA UDI 1f19de89-e08c-4b70-b773-284d50f705cb 35 fields · synced 30 May 2026