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Gastrointestinal motility analysis system - ARTG 484429

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 484429 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.

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Class IIa
ARTG 484429
Class IIa
Gastrointestinal motility analysis system
ARTG ID: 484429
Good Name: Medtronic Australasia Pty Ltd - Gastrointestinal motility analysis system
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Intended Purpose

When used in conjunction with a ballon catheter and the pump unit, the display unit is user interface intended for the user to visualise and create reports for the size and pressure estimates of the gastro-intestinal tract.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
484429
Start Date
March 27, 2025
Effective Date
March 27, 2025
Manufacturer
Country
United States of America
Address
15 Hampshire Street, Mansfield, MA, 02048