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Suction unit, low pressure

Access comprehensive regulatory information for Suction unit, low pressure in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by ICU Medical Australia Pty Ltd, manufactured by ICU Medical Australia Pty Ltd in Australia. The device registration started on September 22, 2017.

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 I
Class I
Suction unit, low pressure
Australia TGA ARTG Registered Device
Good Name: ICU Medical Australia Pty Ltd - Suction unit, low pressure
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Intended Purpose

A device that generates a weak, or low negative pressure used in the treatment of certain patients, e.g. for the aspiration of fluids and/or particulate matter. It is typically used on newborn babies to clear blocked airways and must therefore have a limited negative pressure to avoid unintentional trauma. It may be powered by pressurized gases, or other means.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
Start Date
September 22, 2017
Effective Date
September 22, 2017
Manufacturer
Country
Australia
Address
Unit 4B 128-130 Frances Street, LIDCOMBE, NSW, 2141