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Jazzy Assist

by Beijing OrionStar Technology Co., Ltd

Ref OS-R-M01IModel OS-R-M01S OS-R-M02S OS-R-M03S OS-R-M04S OS-R-M05S OS-R-M01I OS-R-M02I OS-R-M03I OS-R-M04I OS-R-M05I OS-R-M01M OS-R-M02M OS-R-M03M OS-R-M04M OS-R-M05M OS-R-M01A OS-R-M02A OS-R-M03A OS-R-M04A OS-R-M05A

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 Number697895124PWOSRMAQ Basic UDI-DI 06978951240056UDI-DIDate11 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  • Withdrawn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

Device Name
Power Wheelchair
Model / Reference
OS-R-M01S OS-R-M02S OS-R-M03S OS-R-M04S OS-R-M05S OS-R-M01I OS-R-M02I OS-R-M03I OS-R-M04I OS-R-M05I OS-R-M01M OS-R-M02M OS-R-M03M OS-R-M04M OS-R-M05M OS-R-M01A OS-R-M02A OS-R-M03A OS-R-M04A OS-R-M05A, OS-R-M01I
Primary DI / UDI-DI
06978951240056
Basic UDI-DI
697895124PWOSRMAQ
EMDN Code
Y122127 Electric wheelchairs
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048929
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Beijing OrionStar 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