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Rollator

by Danyang Maxthai Medical Equipment Co., Ltd. EUDAMED

Active European Union

Ref R6RD-59Model R6RD-59, R6BL-59, T728, R8RD-59, R8BL-59, 770100100, SA1313000, 735100100(GIGO), 770100100(GoLite200) T103, T104, T30, T800, T615, T616, T430, T620

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697838606RollatorJL Basic UDI-DIDate12 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
R6RD-59, R6BL-59, T728, R8RD-59, R8BL-59, 770100100, SA1313000, 735100100(GIGO), 770100100(GoLite200) T103, T104, T30, T800, T615, T616, T430, T620
Primary DI / UDI-DI
06978386060007
Basic UDI-DI
697838606RollatorJL
EMDN Code
Y120609 Walking frames with chair, 4 wheels
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000013200
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Danyang Maxthai 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