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Electric Wheelchair

by JiaXing XiaoXiang medical equipment Technology Co., Ltd

Ref ME23-EW16-BC200-01Model ME23-EW16-BC200-01 ME23-EW16-BC200-02 ME23-EW16-BC200-03 ME23-EW16-BC200-04 ME23-EW16-BC200-05 ME23-EW16-BC200-06 ME23-EW16-BC200-07

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241189↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK241189 Date29 Oct 2024IssuedStatusActive
European UnionCE/MDR EUDAMED Number697655724EW01Q9 Basic UDI-DI 06976557240012UDI-DIDate1 Aug 2023RegisteredStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
Electric Wheelchair
Model / Reference
ME23-EW16-BC200-01 ME23-EW16-BC200-02 ME23-EW16-BC200-03 ME23-EW16-BC200-04 ME23-EW16-BC200-05 ME23-EW16-BC200-06 ME23-EW16-BC200-07, ME23-EW16-BC200-01
Primary DI / UDI-DI
06976557240012
Basic UDI-DI
697655724EW01Q9
EMDN Code
Y122127 Electric wheelchairs
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000036497
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

Other properties (13)

  • 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