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Power Wheelchair

by Zhejiang Innuovo Rehabilitation Devices Co., Ltd. EUDAMED

Active European Union

Ref W5517Model N5513A,N5515,N5515A,N5516,N5516A,N5516C,W5517,N5517A,N5519,W5521,W5521B,N5525,W5526,W5536,W5536A,W5536B,W5538,N5901,W5905,W5905A,W5907,Q50R Carbon,N5909,N5909A,W5211,W5211B,W5213,W5213C,W5216,N5909D,W5915B,W5915C,W5915D,N5919,N5516D,N5516E,N5516F

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697894946PW001Y3 Basic UDI-DIDate8 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

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.

Specification

EUDAMED

Model / Reference
N5513A, N5515, N5515A, N5516, N5516A, N5516C, W5517, N5517A, N5519, W5521, W5521B, N5525, W5526, W5536, W5536A, W5536B, W5538, N5901, W5905, W5905A, W5907, Q50R Carbon, N5909, N5909A, W5211, W5211B, W5213, W5213C, W5216, N5909D, W5915B, W5915C, W5915D, N5919, N5516D, N5516E, N5516F
Primary DI / UDI-DI
06978949461883
Basic UDI-DI
697894946PW001Y3
EMDN Code
Y122127 Electric wheelchairs
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000008727
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

See all devices from Zhejiang Innuovo Rehabilitation Devices Co., Ltd. →

Properties

  • Administering Medicine

Other properties (12)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No