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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 Orion Laboratories Pty Ltd T/A Perrigo Australia, manufactured by Laboratoire De La Mer in France. The device registration started on June 29, 2022.

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
Class I
Earwax softening otic solution
Australia TGA ARTG Registered Device
Good Name: Orion Laboratories Pty Ltd T/A Perrigo Australia - Earwax softening otic solution
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Intended Purpose

Solution for ear wax removal is intended for auricular application, to soften and help disperse ear was build-up in cases of difficulty in hearing, pain, ringing noise, feeling of blockage and temporary deafness after swimming or showering. Solution for ear wax removal achieves its intended action by mechanical action, it softens and helps disperse ear wax build-up. Solution for ear wax removal is recommended for adults and children over 3 years of age.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 29, 2022
Effective Date
June 29, 2022
Manufacturer
Country
France
Address
ZAC La Madelaine Avenue du General Patton, Saint-Malo, France, 35400