Australia TGA ARTG record

Earwax softening otic solution

Australia TGA ARTG Registered Device · DKSH Healthcare Australia Pty Ltd · PK Benelux BV · Class I · Started October 29, 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: October 29, 2018
Effective Date: October 29, 2018

Sponsor

Name: DKSH Healthcare Australia Pty Ltd

Manufacturer

Name: PK Benelux BV
Country: Netherlands
Address: Vluchtoord 17, Uden, XP, 5406

Intended purpose

A fluid mixture of compounds intended to be applied to the external auditory canal of the ear to facilitate excessive or impacted earwax, impurities or water removal

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 PK Benelux BV in Netherlands. The device registration started on October 29, 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.