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Earwax softening otic solution - ARTG 335857

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 335857 and sponsored by Pharmacor Pty Ltd, manufactured by Alkem Laboratories Limited in India. The device registration started on May 05, 2020.

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
ARTG 335857
Class I
Earwax softening otic solution
ARTG ID: 335857
Good Name: Pharmacor Pty Ltd - Earwax softening otic solution
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Intended Purpose

Intended to be used for ear hygiene, to unblock the ear canal, remove residual ear wax and prevent accumulation.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
335857
Start Date
May 05, 2020
Effective Date
May 05, 2020
Manufacturer
Country
India
Address
167/2 Mahatma Gandhi Udyog Nagar Amaliya, Dabhel, Daman, 396 210