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Rollator

by Hebei Huaen Medical Devices Co., Ltd. 77 variants

Ref HN-ZXQ-L013Model HN-GZ-BD01, HN-GZ-BS01, HN-GZ-BS02, HN-GZ-BS03, HN-GZ-LD01, HN-GZ-LD02, HN-GZ-LD03, HN-GZ-LS01, HN-GZ-LS02, HN-GZ-LS03, HN-GZ-LS04, HN-GZ-LS05, HN-GZ-LS06, HN-GZ-LS07, HN-GZ-LS08, HN-GZ-LS09, HN-GZ-LS09, HN-GZ-LS10, HN-GZ-LS11, HN-GZ-LZ01etc

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698021129RLTPW Basic UDI-DI 06980211292309UDI-DIDate23 Jun 2026RegisteredStatusActive

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  • Withdrawn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
HN-GZ-BD01, HN-GZ-BS01, HN-GZ-BS02, HN-GZ-BS03, HN-GZ-LD01, HN-GZ-LD02, HN-GZ-LD03, HN-GZ-LS01, HN-GZ-LS02, HN-GZ-LS03, HN-GZ-LS04, HN-GZ-LS05, HN-GZ-LS06, HN-GZ-LS07, HN-GZ-LS08, HN-GZ-LS09, HN-GZ-LS10, HN-GZ-LS11, HN-GZ-LZ01etc, HN-ZXQ-L013
Primary DI / UDI-DI
06980211292309
Basic UDI-DI
698021129RLTPW
EMDN Code
Y120609 Walking frames with chair, 4 wheels
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000056467
Authorised representative
HyperCert Limited B.V. NL-AR-000047746

Other devices from Hebei Huaen Medical Devices Co., Ltd.

See all devices from Hebei Huaen Medical Devices 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