Australia TGA ARTG record

Manual biliary stone fragmenter

Australia TGA ARTG Registered Device · Olympus Australia Pty Ltd · Olympus Medical Systems Corporation · Class Is · Started May 18, 2023

Good Name: Olympus Australia Pty Ltd - Manual biliary stone fragmenter

Device classification

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

Registration information

Start Date: May 18, 2023
Effective Date: May 18, 2023

Sponsor

Name: Olympus Australia Pty Ltd

Manufacturer

Name: Olympus Medical Systems Corporation
Country: Japan
Address: 2951 Ishikawa-cho, Hachioji- shi, Tokyo, 192-8507

Intended purpose

A manual instrument intended to be used in conjunction with an Olympus lithotriptor and basket type grasping forceps for crushing biliary calculi in the bile duct and removing the basket from the patient.

About this record

Access comprehensive regulatory information for Manual biliary stone fragmenter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Olympus Australia Pty Ltd, manufactured by Olympus Medical Systems Corporation in Japan. The device registration started on May 18, 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.