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Medical equipment drape, single-use - ARTG 470391

Access comprehensive regulatory information for Medical equipment drape, 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 470391 and sponsored by Medtronic Australasia Pty Ltd, manufactured by Microtek Medical Inc in United States of America. The device registration started on November 26, 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.

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TGA ARTG Official Data
Class Is
ARTG 470391
Class Is
Medical equipment drape, single-use
ARTG ID: 470391
Good Name: Medtronic Australasia Pty Ltd - Medical equipment drape, single-use
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Intended Purpose

This device is an equipment drape which is intended to cover the O-arm Imaging System equipment and function as a physical barrier to prevent cross-contamination between the equipment and medical staff and/or to allow the equipment to enter a hygienic area in various clinical settings.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
470391
Start Date
November 26, 2024
Effective Date
November 26, 2024
Manufacturer
Country
United States of America
Address
1 Ecolab Place, St Paul, MN, 55102