Australia TGA ARTG record

Earwax softening otic solution

Australia TGA ARTG Registered Device · DKSH Healthcare Australia Pty Ltd · Danima Smart Solution Ltd · Class I · Started September 17, 2018

Good Name: DKSH Healthcare Australia Pty Ltd- Earwax softening otic solution

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

Sponsor

Name: DKSH Healthcare Australia Pty Ltd

Manufacturer

Name: Danima Smart Solution Ltd
Country: Netherlands
Address: Joop Geesinkweg 701 1114 AB, Amsterdam

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

About this record

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.