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Rollator

by Hebei Dansong Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref RO04Model RO01,RO02,RO03,RO04,RO05,RO06,RO07,RO08,RO09,RO10,ROL01,ROL02,ROL03,ROL04,ROL05,ROL06,ROL07,ROL08,ROL09,ROL10

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697835668ROLLATOR4Y Basic UDI-DIDate7 Apr 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Rollator
Model / Reference
RO01, RO02, RO03, RO04, RO05, RO06, RO07, RO08, RO09, RO10, ROL01, ROL02, ROL03, ROL04, ROL05, ROL06, ROL07, ROL08, ROL09, ROL10
Primary DI / UDI-DI
06978356680136
Basic UDI-DI
697835668ROLLATOR4Y
EMDN Code
Y120606 Wheeled walker
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000047302
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hebei Dansong Medical Technology Co., Ltd.

See all devices from Hebei Dansong Medical 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