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Earwax softening otic solution

Access comprehensive regulatory information for Earwax softening otic solution 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 September 17, 2018.

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
Earwax softening otic solution
Australia TGA ARTG Registered Device
Good Name: DKSH Healthcare Australia Pty Ltd- Earwax softening otic solution
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Intended Purpose

A fluid mixture of oils and compounds intended to be applied to the external auditory canal of the ear to facilitate excessive or impacted earwax, impurities or water removal . Soften ear wax and alleviate itching and irritation in the external auditory canal

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 17, 2018
Effective Date
September 17, 2018
Manufacturer
Country
Netherlands
Address
Joop Geesinkweg 701 1114 AB, Amsterdam