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Endotherapy overtube, single-use

Access comprehensive regulatory information for Endotherapy overtube, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by William A Cook Australia Pty Ltd, manufactured by Cook Ireland Ltd in Ireland. The device registration started on October 25, 2016.

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
Endotherapy overtube, single-use
Australia TGA ARTG Registered Device
Good Name: William A Cook Australia Pty Ltd - Endotherapy overtube, single-use
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Intended Purpose

The Zenker's Diverticulum Overtube is a device intended to act as a diverticuloscope for the purpose of creating a diverticulotomy in patients with Zenker's Diverticulum. The device is supplied sterile and is not intended for reuse.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 25, 2016
Effective Date
October 25, 2016
Manufacturer
Country
Ireland
Address
O'Halloran Road National Technology Park, Limerick