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Electric Wheelchair

by hangzhoubokangyiliaoqixieyouxiangongsi

Ref BK-EC8003-S02Model BK-EWS001； BK-EWS002 ；BK-EWS003； BK-EWS004 ；BK-EWS005； BK-EWS006； BK-EWS007； BK-EWS008； BK-EWS009； BK-EWS010； BK-EWS011; BK-EWS101; BK-EWS102； BK-EWS103 ；BK-EWS104； BK-EWS105； BK-EWS106； BK-EWS107；etc

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697983521EWheelchairFM Basic UDI-DI 06979835210004UDI-DIDate24 Feb 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Electric Wheelchair
Model / Reference
BK-EWS001； BK-EWS002 ；BK-EWS003； BK-EWS004 ；BK-EWS005； BK-EWS006； BK-EWS007； BK-EWS008； BK-EWS009； BK-EWS010； BK-EWS011, BK-EWS101, BK-EWS102； BK-EWS103 ；BK-EWS104； BK-EWS105； BK-EWS106； BK-EWS107；etc, BK-EC8003-S02
Primary DI / UDI-DI
06979835210004
Basic UDI-DI
697983521EWheelchairFM
EMDN Code
Y122127 Electric wheelchairs
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000051656
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from hangzhoubokangyiliaoqixieyouxiangongsi

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