Pure Global

Catheter balloon inflation system, single-use - ARTG 463626

Access comprehensive regulatory information for Catheter balloon inflation system, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 463626 and sponsored by PlainSolution, manufactured by Jiangsu Vedkang Medical Science & Technology Co Ltd in China. The device registration started on October 04, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class Is
ARTG 463626
Class Is
Catheter balloon inflation system, single-use
ARTG ID: 463626
Good Name: PlainSolution - Catheter balloon inflation system, single-use
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

An assembly of devices used with a balloon dilatation catheter to manually inflate and regulate pressure within the catheter's balloon and to deflate the balloon in association with a medical procedure. It consists of a dedicated syringe/plunger, a gauge for monitoring pressure, a locking mechanism, and a connecting tube.This is a single-use device

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
463626
Start Date
October 04, 2024
Effective Date
October 04, 2024
Sponsor
Manufacturer
Country
China
Address
No 52 Guoxiang Road Wujin Economic Development Zone, Changzhou Jiangsu, 213149