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Rollator

by INTCO MEDICAL (HK) CO., ltd 6 variants

Ref SDMSTAR 019, Y12, R505, SDMSTAR 090Model YK7010, YK7030, YK7050, YK7060,SPIRIT X3,SPIRIT X4, Movo-F

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 Number489712866-0-RollatorE4 Basic UDI-DI Date2 Dec 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
YK7010, YK7030, YK7050, YK7060, SPIRIT X3, SPIRIT X4, Movo-F, SDMSTAR 019, Y12, R505, SDMSTAR 090
Primary DI / UDI-DI
04897128665237, 04897128662915, 04897128666814, 04897128666692
Basic UDI-DI
489712866-0-RollatorE4
Direct Marketing DI
04897128665237
04897128666814
04897128666692
EMDN Code
Y120609, Y120606
Device Class
Class I
EU market of registration
Türkiye
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000011338
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from INTCO MEDICAL (HK) CO., ltd

See all devices from INTCO MEDICAL (HK) 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