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Manual biliary stone fragmenter handle, noninvasive, single-use

Access comprehensive regulatory information for Manual biliary stone fragmenter handle, noninvasive, single-use 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 Corp in Japan. The device registration started on July 17, 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 Is
Class Is
Manual biliary stone fragmenter handle, noninvasive, single-use
Australia TGA ARTG Registered Device
Good Name: Olympus Australia Pty Ltd - Manual biliary stone fragmenter handle, noninvasive, single-use
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Intended Purpose

A single-use, sterile handle that is intended to be used with a basket for crushing calculi inside the bile duct.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 17, 2023
Effective Date
July 17, 2023
Manufacturer
Country
Japan
Address
2951 Ishikawa-cho Hajioji-shi, Tokyo, 192-8507