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Manual wheelchair

by Changzhou Synwin Medical Equipment Co., Ltd.

Ref YK9081Model YK9081/YK89012/YK89022/YK89031/YK89032F/YK89041/YK89045/YK89073/YK89034/YK89065 /YK89050K1/YK89052K2/YK89053K3/YK89052BK7/YK89130/YK89132/YK89090/YK89092/YK89093/YK89061/YK89061M/YK89063/YK89064F/YK89067/YK89068/YK89070 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697985303MW001QW Basic UDI-DI Date25 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  • Withdrawn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
Manual wheelchair
Model / Reference
YK9081/YK89012/YK89022/YK89031/YK89032F/YK89041/YK89045/YK89073/YK89034/YK89065 /YK89050K1/YK89052K2/YK89053K3/YK89052BK7/YK89130/YK89132/YK89090/YK89092/YK89093/YK89061/YK89061M/YK89063/YK89064F/YK89067/YK89068/YK89070 etc, YK9081
Primary DI / UDI-DI
06979853030813, 06979853034439
Basic UDI-DI
697985303MW001QW
EMDN Code
Y122103 Push wheelchairs
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000051436
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Changzhou Synwin Medical Equipment 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