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Electrically powered wheelchair

by Kunshan Hi-Fortune Health Products Co., Ltd China EUDAMED

Ref HP458EModel HP358E、HP358EA、HP202、HP201、HP200、HP458E、EY07、EY18、P15、P55、HP203、HP204、HP205、HP206、HP207、HP208、HP209、HP210、HP211、HP212

EMDN Y122127

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697385259Ewheelchair95 Basic UDI-DIDate2 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Electrically powered wheelchair
Model / Reference
HP358E、HP358EA、HP202、HP201、HP200、HP458E、EY07、EY18、P15、P55、HP203、HP204、HP205、HP206、HP207、HP208、HP209、HP210、HP211、HP212, HP458E
Primary DI / UDI-DI
06973852594406, 06973852594383, 06973852594420
Basic UDI-DI
697385259Ewheelchair95
EMDN Code
Y122127 Electric wheelchairs
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000035403
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Kunshan Hi-Fortune Health Products Co., Ltd

See all devices from Kunshan Hi-Fortune Health Products Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (3)

  • EUDAMED 584e1ddd-111b-466d-973c-f66189eafdf8 61 fields · synced 23 Oct 2026
  • EUDAMED 06973852594383|697385259EWHEELCHAIR95 61 fields · synced 12 Oct 2026
  • EUDAMED 06973852594420|697385259EWHEELCHAIR95 61 fields · synced 24 Oct 2026