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Operating room device management system - ARTG 409673

Access comprehensive regulatory information for Operating room device management system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 409673 and sponsored by Olympus Australia Pty Ltd, manufactured by Gyrus Acmi Inc in United States of America. The device registration started on May 26, 2023.

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 I
ARTG 409673
Class I
Operating room device management system
ARTG ID: 409673
Good Name: Olympus Australia Pty Ltd - Operating room device management system
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Intended Purpose

A digital video/image recording and communication system that assists in video/image capture of medical surgical procedures. The system does control or alter the functions of any connected devices. The captured video/images are not intended to be used for diagnosis or treatment.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
409673
Start Date
May 26, 2023
Effective Date
May 26, 2023
Manufacturer
Country
United States of America
Address
9600 Louisiana Avenue North, Brooklyn Park, MN, 55445