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Mobility Scooter

by Shenzhen Zhimahuaerkai Technology Co., Ltd. 6 variants

Ref L5 PROModel S3, S1, S1 PRO, S3 PRO， L5, L5PRO

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) K253643↗

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) NumberK253643 Date18 Feb 2026IssuedStatusActive
European UnionCE/MDR EUDAMED Number697641078PPX001RP Basic UDI-DI 06976410780075UDI-DIDate12 Apr 2024RegisteredStatusActive

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  • Withdrawn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
Model / Reference
S3, S1, S1 PRO, S3 PRO， L5, L5PRO, L5 PRO
Primary DI / UDI-DI
06976410780075
Basic UDI-DI
697641078PPX001RP
EMDN Code
Y122124 Electric scooters
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000039566
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen Zhimahuaerkai Technology Co., Ltd.

See all devices from Shenzhen Zhimahuaerkai 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