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Scooter

by Tianjin Kepler Vehicle Industry Co., Ltd EUDAMED510(k)

Active United States and European Union

Ref KPL00204Model KPL002

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697400707KPL002EC Basic UDI-DIDate14 Jun 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK182471 Date10 Jul 2019IssuedStatusActive

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · 510(k)

Device Name
Scooter
Model / Reference
KPL002, KPL00204
Primary DI / UDI-DI
06974007070318
Basic UDI-DI
697400707KPL002EC
EMDN Code
Y122124 Electric scooters
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000009029
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Tianjin Kepler Vehicle Industry Co., Ltd

See all devices from Tianjin Kepler Vehicle Industry 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