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Portable Wheelchair

by Intradin (Shanghai) Machinery Co., Ltd.

Ref PMS302/GBTS021/GEUTS099/GBTS041/GEUTS117Model PMS302, GBTS021, GEUTS099, GBTS041, GEUTS117

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) K243970↗

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
European UnionCE/MDR EUDAMED Number69439407EWHEELCHAIR8L Basic UDI-DI 06943940739729UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK243970 Date7 Mar 2025IssuedStatusActive

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  • Withdrawn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
Portable Wheelchair
Model / Reference
PMS302, GBTS021, GEUTS099, GBTS041, GEUTS117, PMS302/GBTS021/GEUTS099/GBTS041/GEUTS117
Primary DI / UDI-DI
06943940739729
Basic UDI-DI
69439407EWHEELCHAIR8L
EMDN Code
Y122127 Electric wheelchairs
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000034847
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Intradin (Shanghai) Machinery Co., Ltd

See all devices from Intradin (Shanghai) Machinery Co., Ltd →

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