Australia TGA ARTG record

Operating room device management system

Australia TGA ARTG Registered Device · Olympus Australia Pty Ltd · Gyrus Acmi Inc · Class I · Started May 26, 2023

Good Name: Olympus Australia Pty Ltd - Operating room device management system

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 26, 2023
Effective Date: May 26, 2023

Sponsor

Name: Olympus Australia Pty Ltd

Manufacturer

Name: Gyrus Acmi Inc
Country: United States of America
Address: 9600 Louisiana Avenue North, Brooklyn Park, MN, 55445

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.

About this record

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 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.