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Clinical data collection/management information application software - ARTG 484446

Access comprehensive regulatory information for Clinical data collection/management information application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 484446 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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TGA ARTG Official Data
Class IIa
ARTG 484446
Class IIa
Clinical data collection/management information application software
ARTG ID: 484446
Good Name: Medtronic Australasia Pty Ltd - Clinical data collection/management information application software
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Intended Purpose

The reader software is used post-procedure, it enables a user to view recordings on a computer that is not the part of the recording device. The recordings are intended for a user to visualise the size and pressure estimates of the gastro-intestinal tract. Note, the reader is for viewing of recordings only, it is not the user interface of the recording device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
484446
Start Date
March 27, 2025
Effective Date
March 27, 2025
Manufacturer
Country
United States of America
Address
15 Hampshire Street, Mansfield, MA, 02048