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Pneumatic Weight Loss Gait Training System

by Tianjin GoldenAll Medical Device Co., LTD 29 variants

Ref CELE H7, GA280S, VR02, AERO 5, AERO S15, GA20, GA80, AERO SP15, AERO 8, CELE L7, AERO 15, CELE L1, CELE L3, CELE H1, AERO S5, CELE H5, GA60, GA60S, GA300, VR10, AERO GP15, GA100, CELE H3Model GA100S/GA80S/GA60S/GA100/GA80/GA60/GA20/ AERO GSP8/AERO SP8/AERO S8/AERO GP8/AERO P8/AERO P8R/AERO 8/AERO 8R/AERO GSP5 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697509503ANTIG-TREADMILK6 Basic UDI-DI Date14 Jul 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Pneumatic Weight Loss Gait Training System
Model / Reference
GA100S/GA80S/GA60S/GA100/GA80/GA60/GA20/ AERO GSP8/AERO SP8/AERO S8/AERO GP8/AERO P8/AERO P8R/AERO 8/AERO 8R/AERO GSP5 etc, CELE H7, GA280S, VR02, AERO 5, AERO S15, GA20, GA80, AERO SP15, AERO 8, CELE L7, AERO 15, CELE L1, CELE L3, CELE H1, AERO S5, CELE H5, GA60, GA60S, GA300, VR10, AERO GP15, GA100, CELE H3
Primary DI / UDI-DI
06975095031045, 06975095030048, 06975095031168, 06975095030444, 06975095030277, 06975095030093, 06975095030055, 06975095030260, 06975095030383, 06975095031083, 06975095030314, 06975095031113, 06975095031106, 06975095031076, 06975095030413, 06975095031052, 06975095030086, 06975095030079, 06975095030130, 06975095031120, 06975095030284, 06975095030000, 06975095031069
Basic UDI-DI
697509503ANTIG-TREADMILK6
EMDN Code
Z129006 Treadmills for physiotherapy and/or diagnostic uses
Device Class
Class I
EU market of registration
Austria
Netherlands
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000017353
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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