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Pneumatic Weight Loss Gait Training System

by Tianjin GoldenAll Medical Device Co., LTD

Ref GSP8Model 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. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697509503ANTIG-TREADMILK6 Basic UDI-DI 06975095030017UDI-DIDate14 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06975095030017 UDI-DI Date24 Dec 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
GoldenAll
Generic Name
Standard treadmill, powered
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 EUDAMED
GSP8 EUDAMED
AERO GSP8 GUDID
Primary DI / UDI-DI
06975095030017
Basic UDI-DI
697509503ANTIG-TREADMILK6
FDA Product Code
BXB
EMDN Code
M030599 Immobilisation systems and devices - other
GMDN Term
Standard treadmill, powered
Device Class
Class I
Regulation Number
890.5380
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Manufacturer details

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

Other devices from Tianjin GoldenAll Medical Device Co., LTD

See all devices from Tianjin GoldenAll Medical Device Co., LTD →

Properties

  • Premarket Exempt
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No