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Ear canal lavage system - ARTG 442092

Access comprehensive regulatory information for Ear canal lavage system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 442092 and sponsored by Substance Pty Ltd, manufactured by Logikal Health Products Pty Ltd in Australia. The device registration started on February 22, 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 I
ARTG 442092
Class I
Ear canal lavage system
ARTG ID: 442092
Good Name: Substance Pty Ltd - Ear canal lavage system
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Intended Purpose

Ear spray solution aiding in the removal of ear wax in the external ear canal through irrigation and dissolution. When applied to earwax the combination of kinetic energy and oily forumulation is intended to soften and lubricate ear wax aiding in its removal.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
442092
Start Date
February 22, 2024
Effective Date
February 22, 2024
Manufacturer
Country
Australia
Address
Unit 3 18-20 Accolade Avenue, MORISSET, NSW, 2264