Pure Global

Cervical dilatation balloon catheter stylet - ARTG 445670

Access comprehensive regulatory information for Cervical dilatation balloon catheter stylet in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 445670 and sponsored by Multigate Medical Devices Pty Ltd, manufactured by Multigate Co Ltd in China. The device registration started on April 11, 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 445670
Class Is
Cervical dilatation balloon catheter stylet
ARTG ID: 445670
Good Name: Multigate Medical Devices Pty Ltd - Cervical dilatation balloon catheter stylet
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

A thin, semi-rigid rod intended to be inserted into the lumen of a cervical dilatation balloon catheter (not included) to allow for catheter introduction into the cervical canal. It has a J-shaped proximal end to allow manipulation/stabilization. This is a single-use device.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
445670
Start Date
April 11, 2024
Effective Date
April 11, 2024
Manufacturer
Country
China
Address
No 7 Lanjiang Road, Shaoxing, 312000