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Mobility scooter for disabled and elderly

by Zhejiang Wei Ling New Energy Technology Co., Ltd. 42 variants

Ref CL-24N04Model CL-21Z、CL-21Z-1、CL-21Z-2、CL-21Z-3、CL-06Z-60、CL-30ZR-60、CL-20N03-2、CL-20N04-2、CL-2W、CL-2W-1、CL-2W-2、etc

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) K253631↗

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) NumberK253631 Date23 Feb 2026IssuedStatusActive
European UnionCE/MDR EUDAMED Number697874686WLMS4H Basic UDI-DI 06978746860230UDI-DIDate5 Jun 2025RegisteredStatusActive

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  • Withdrawn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
Mobility scooter for disabled and elderly
Model / Reference
CL-21Z、CL-21Z-1、CL-21Z-2、CL-21Z-3、CL-06Z-60、CL-30ZR-60、CL-20N03-2、CL-20N04-2、CL-2W、CL-2W-1、CL-2W-2、etc, CL-24N04
Primary DI / UDI-DI
06978746860230
Basic UDI-DI
697874686WLMS4H
EMDN Code
Y122124 Electric scooters
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047238
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhejiang Wei Ling New Energy Technology Co., Ltd.

See all devices from Zhejiang Wei Ling New Energy Technology 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