Australia TGA ARTG record

Alcoholic/acidic ear drops

Australia TGA ARTG Registered Device · Substance Pty Ltd · Logikal Health Products Pty Ltd · Class I · Started May 14, 2024

Good Name: Substance Pty Ltd - Alcoholic/acidic ear drops

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 14, 2024
Effective Date: May 14, 2024

Sponsor

Name: Substance Pty Ltd

Manufacturer

Name: Logikal Health Products Pty Ltd
Country: Australia
Address: Unit 3 18-20 Accolade Avenue, MORISSET, NSW, 2264

Intended purpose

A solution containing alcohol and a weak acid (acetic acid). When applied as a spray it effectively reaches the ear canal to help prevent infection and inflammation associated with water exposure.

About this record

Access comprehensive regulatory information for Alcoholic/acidic ear drops in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Substance Pty Ltd, manufactured by Logikal Health Products Pty Ltd in Australia. The device registration started on May 14, 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.