Australia flagARTG 463606

Catheter, gastrointestinal balloon

ARTG ID: 463606 · PlainSolution · Jiangsu Vedkang Medical Science & Technology Co Ltd · Class IIa · Started October 03, 2024

Good Name: PlainSolution - Catheter, gastrointestinal balloon

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
463606
Start Date
October 03, 2024
Effective Date
October 03, 2024
Sponsor
Manufacturer
Country
China
Address
No 52 Guoxiang Road Wujin Economic Development Zone, Changzhou Jiangsu, 213149
Intended purpose

It is a thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures, especially of the oesophagus, pylorus, or colon. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. This is a single-use device.

About this record

Access comprehensive regulatory information for Catheter, gastrointestinal balloon in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 463606 and sponsored by PlainSolution, manufactured by Jiangsu Vedkang Medical Science & Technology Co Ltd in China. The device registration started on October 03, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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