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Walking Aids, Rollator

by Guangzhou Topmedi Co., Ltd. 31 variants

Ref TWA201Model TWA9127L,TWA004,TWA009,THE965L,TWA965LH,TWA965LH-1,TWA965LH-A,THE965LF1,TWA9650LH,TWA965LH-B,TWA965LHF1,TWA966LH,TWA966LH-B, etc

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 Number697438762TWA001UZ Basic UDI-DI 06974387624842UDI-DIDate13 Sep 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  • Withdrawn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
TWA9127L, TWA004, TWA009, THE965L, TWA965LH, TWA965LH-1, TWA965LH-A, THE965LF1, TWA9650LH, TWA965LH-B, TWA965LHF1, TWA966LH, TWA966LH-B, etc, TWA201
Primary DI / UDI-DI
06974387624842
Basic UDI-DI
697438762TWA001UZ
EMDN Code
Y120606 Wheeled walker
Device Class
Class I
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000016883
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Guangzhou Topmedi Co., Ltd.

See all devices from Guangzhou Topmedi 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