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Earwax softening otic solution - ARTG 310835

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 registered under ARTG number 310835 and 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.

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TGA ARTG Official Data
Class I
ARTG 310835
Class I
Earwax softening otic solution
ARTG ID: 310835
Good Name: DKSH Healthcare Australia Pty Ltd- Earwax softening otic solution
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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

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
310835
Start Date
October 29, 2018
Effective Date
October 29, 2018
Manufacturer
Country
Netherlands
Address
Vluchtoord 17, Uden, XP, 5406