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Tracheostomy button

Access comprehensive regulatory information for Tracheostomy button in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Precise Medical Supplies Pty Ltd, manufactured by Medasil Surgical Ltd in United Kingdom. The device registration started on May 12, 2021.

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 IIb
Class IIb
Tracheostomy button
Australia TGA ARTG Registered Device
Good Name: Precise Medical Supplies Pty Ltd - Tracheostomy button
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Intended Purpose

Intended to be used for temporary non-surgical maintenance of tracheostomas. It is a single patient use invasive device to be used in direct contact with the mucosal membrane. It is intended to be used up to 29 days, however the duration of the patient body contact can be long term (>29 days) as possible repeat applications with new devices on a patient are foreseen.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 12, 2021
Effective Date
May 12, 2021
Manufacturer
Country
United Kingdom
Address
Medasil House Hunslet Road, Leeds, LS10 1AU