Pure Global

Gastrointestinal motility analysis system - ARTG 484405

Access comprehensive regulatory information for Gastrointestinal motility analysis system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 484405 and sponsored by Medtronic Australasia Pty Ltd, manufactured by Covidien llc in United States of America. The device registration started on March 27, 2025.

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 IIa
ARTG 484405
Class IIa
Gastrointestinal motility analysis system
ARTG ID: 484405
Good Name: Medtronic Australasia Pty Ltd - Gastrointestinal motility analysis system
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

When used in conjunction with a balloon catheter, the pump unit is intended inflate and deflate the balloon catheter and perform data capturing that allows estimates for the size and pressure of the gastro-intestinal (GI) tract. It also enables dilation of the GI tract.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
484405
Start Date
March 27, 2025
Effective Date
March 27, 2025
Manufacturer
Country
United States of America
Address
15 Hampshire Street, Mansfield, MA, 02048