rollator

by Zhongshan Onecare MedicaI Equipment Co Ltd

Ref On800Model On800 On801 On802 On803 On804 On805 On806 On807 On808 On809 On810 On811 On812 On813 On814 On815 On816 On817 On818 On819 On820 On821 On822 On823 On824 On825

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

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697815871ONROWE Basic UDI-DI 06978158718006UDI-DI	Date14 Feb 2025Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: rollator
Model / Reference: On800 On801 On802 On803 On804 On805 On806 On807 On808 On809 On810 On811 On812 On813 On814 On815 On816 On817 On818 On819 On820 On821 On822 On823 On824 On825, On800

Primary DI / UDI-DI: 06978158718006
Basic UDI-DI: 697815871ONROWE
EMDN Code: Y120606 Wheeled walker

Device Class: Class I
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000045105
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhongshan Onecare MedicaI Equipment Co Ltd

Shower chair

Class I

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