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Alcoholic/acidic ear drops

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 DKSH Healthcare Australia Pty Ltd, manufactured by Danima Smart Solution Ltd in Netherlands. The device registration started on July 19, 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
Alcoholic/acidic ear drops
Australia TGA ARTG Registered Device
Good Name: DKSH Healthcare Australia Pty Ltd- Alcoholic/acidic ear drops
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Intended Purpose

A non-sterile solution composed of an alcohol (e.g., isopropyl) and/or an acid (e.g., acetic), as the primary agent(s) intended to be applied in drops to the external auditory canal of the ear to prevent and treat canal inflammation associated with water exposure.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 19, 2017
Effective Date
July 19, 2017
Manufacturer
Country
Netherlands
Address
Joop Geesinkweg 701 1114 AB, Amsterdam