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Power Wheelchair

by Zhejiang Innuovo Rehabilitation Devices Co., Ltd. 20 variants

Ref N5516DModel 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

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697894946PW001Y3 Basic UDI-DI 06978949463016UDI-DIDate8 Aug 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  • Withdrawn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

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
06978949463016
Basic UDI-DI
697894946PW001Y3
EMDN Code
Y122127 Electric wheelchairs
Device Class
Class I
EU market of registration
Germany

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.

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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