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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 Substance Pty Ltd, manufactured by Naveh Pharma Ltd in Israel. The device registration started on August 29, 2019.

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: Biorevive Pty Ltd - Alcoholic/acidic ear drops
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Intended Purpose

A non-sterile solution composed of alcohol and a weak intended to be applied as a spray to the external auditory canal of the ear to prevent canal inflammation associated with water exposure (Swimmerโ€™s Ear), especially after bathing, showering, swimming, or diving. The alcohol and acid are intended to dry the canal and help restore the canal to its normal acidic pH respectively, to inhibit microbiological growth.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 29, 2019
Effective Date
August 29, 2019
Manufacturer
Country
Israel
Address
19 Harutzim St, Poleg Industrial Zone, Netanya, 42505