Australia TGA ARTG record

Electrosurgical diathermy/ultrasonic surgical generator

Australia TGA ARTG Registered Device · Olympus Australia Pty Ltd · Olympus Winter & Ibe GmbH · Class IIb · Started February 20, 2024

Good Name: Olympus Australia Pty Ltd - Electrosurgical diathermy/ultrasonic surgical generator

Device classification

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

Registration information

Start Date: February 20, 2024
Effective Date: February 20, 2024

Sponsor

Name: Olympus Australia Pty Ltd

Manufacturer

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

Intended purpose

The electrosurgical generator, in conjunction with compatible devices and accessories, is intended for cutting and coagulation of soft tissue and for ligation of vessels. It uses monopolar and bipolar high frequency current and supports ultrasonic instruments. It is intended for use in open, laparoscopic and endoscopic surgery.

About this record

Access comprehensive regulatory information for Electrosurgical diathermy/ultrasonic surgical generator 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 February 20, 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.