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Filter, humidifier, heat/moisture exchanger - ARTG 346471

Access comprehensive regulatory information for Filter, humidifier, heat/moisture exchanger in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 346471 and sponsored by Intersurgical Australia Pty Ltd, manufactured by GVS Filter Technology UK Ltd in United Kingdom. The device registration started on October 23, 2020.

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 IIa
ARTG 346471
Class IIa
Filter, humidifier, heat/moisture exchanger
ARTG ID: 346471
Good Name: Intersurgical Australia Pty Ltd - Filter, humidifier, heat/moisture exchanger
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Intended Purpose

A dedicated membrane that is inserted into a reusable heat & moisture exchanger (HME) to capture a patient's exhaled heat and moisture, so that they can be used to heat and humidify therapeutic gases inspired by the patient typically during anaesthesia or intensive care ventilation. This is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
346471
Start Date
October 23, 2020
Effective Date
October 23, 2020
Manufacturer
Country
United Kingdom
Address
NFC House Vickers Industrial Estate Mellishaw Lane, Morecambe, Lancashire, LA3 3EN