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Tube, laryngectomy - ARTG 470265

Access comprehensive regulatory information for Tube, laryngectomy in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 470265 and sponsored by Teleflex Medical Australia Pty Ltd, manufactured by Teleflex Medical in Ireland. The device registration started on November 25, 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.

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Class IIb
ARTG 470265
Class IIb
Tube, laryngectomy
ARTG ID: 470265
Good Name: Teleflex Medical Australia Pty Ltd - Tube, laryngectomy
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Intended Purpose

LaryngoFlex is to be used for laryngectomies, head and neck surgery and maxillo-facial surgery. LaryngoFlex is indicated for tracheal placement via a tracheostomy stoma. The device is only for use by medical doctors and trained physicians, and is intended for the successful facilitation of mechanical ventilation or spontaneous respiration of adult patients when connected to a breathing system. They are sterile, single-use, and are designed for short-term use.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
470265
Start Date
November 25, 2024
Effective Date
November 25, 2024
Manufacturer
Country
Ireland
Address
IDA Business and Technology Park Dublin Road, Athlone, Co Westmeath