Pure Global

Alcoholic/acidic ear drops - ARTG 448526

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 registered under ARTG number 448526 and 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 448526
Class I
Alcoholic/acidic ear drops
ARTG ID: 448526
Good Name: Substance Pty Ltd - Alcoholic/acidic ear drops
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
448526
Start Date
May 14, 2024
Effective Date
May 14, 2024
Manufacturer
Country
Australia
Address
Unit 3 18-20 Accolade Avenue, MORISSET, NSW, 2264