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Electric wheelchair

by Zhejiang Kailang Technology Co., Ltd.

Ref KL-N8001Model KL-N8001、KL-N8002、KL-N8003、KL-N8004、KL-N8005、KL-N8006、KL-N8007、KL-N8008、KL-N8009、KL-N8010

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 Number697924683EW001N2 Basic UDI-DI 06979246830013UDI-DIDate29 Dec 2025RegisteredStatusActive

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  • Withdrawn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
KL-N8001、KL-N8002、KL-N8003、KL-N8004、KL-N8005、KL-N8006、KL-N8007、KL-N8008、KL-N8009、KL-N8010, KL-N8001
Primary DI / UDI-DI
06979246830013
Basic UDI-DI
697924683EW001N2
EMDN Code
Y122127 Electric wheelchairs
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000051108
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhejiang Kailang 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