Australia TGA ARTG record

Electrosurgical system generator, general-purpose

Australia TGA ARTG Registered Device · Olympus Australia Pty Ltd · Olympus Winter & Ibe GmbH · Class IIb · Started July 23, 2021

Good Name: Olympus Australia Pty Ltd - Electrosurgical system generator, general-purpose

Device classification

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

Registration information

Start Date: July 23, 2021
Effective Date: July 23, 2021

Sponsor

Name: Olympus Australia Pty Ltd

Manufacturer

Name: Olympus Winter & Ibe GmbH
Country: Germany
Address: Kuehnstrasse 61, Hamburg, 22045

Intended purpose

An electrosurgical generator used for the cutting of body tissue and coagulation of the incision/wound, by generating high frequency current. It is used in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.

About this record

Access comprehensive regulatory information for Electrosurgical system generator, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Olympus Australia Pty Ltd, manufactured by Olympus Winter & Ibe GmbH in Germany. The device registration started on July 23, 2021.

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.