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Mobility Scooter

by Yongkang Yile Vehicle Co., Ltd EUDAMED510(k)GUDID

Active United States and European Union

Ref YL-07Model YL-01S,YL-07T,YL-07C,YL-09B,YL-09S,YL-08A,YL-08G,YL-985,YL-985S,YL-985A,YL-211A,YL-02,YL-02A,YL-309S,YL-996,YL-996A,YL-01,YL-07,YL-08,YL-09,YL-010,YL-16,YL-18,YL-211,YL-211S,YL-211X,YL-308,YL-308L, YL-309,YL-985L,YL-TK300,YL-TK500,YL-TK700,YL-TK800,etc

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06977767680315 UDI-DIDate12 Jun 2025ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number697776768MS01XB Basic UDI-DIDate28 Feb 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK242139 Date6 Jan 2025IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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) · GUDID

Trade Name
onefun
Generic Name
Assistive scooter, electric-motor-driven
Device Name
Mobility Scooter
Model / Reference
YL-01S, YL-07T, YL-07C, YL-09B, YL-09S, YL-08A, YL-08G, YL-985, YL-985S, YL-985A, YL-211A, YL-02, YL-02A, YL-309S, YL-996, YL-996A, YL-01, YL-07, YL-08, YL-09, YL-010, YL-16, YL-18, YL-211, YL-211S, YL-211X, YL-308, YL-308L, YL-309, YL-985L, YL-TK300, YL-TK500, YL-TK700, YL-TK800, etc
Primary DI / UDI-DI
06977767680315
Basic UDI-DI
697776768MS01XB
510(k) Number
FDA Product Code
INI
EMDN Code
Y122124 Electric scooters
GMDN Term
Assistive scooter, electric-motor-driven
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
890.3800
Market of Registration
Austria
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000046533
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Yongkang Yile Vehicle Co., Ltd

See all devices from Yongkang Yile Vehicle Co., Ltd →

Properties

  • Lot / Batch Number
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No