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Earwax softening otic solution - ARTG 422042

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 IIa is registered under ARTG number 422042 and sponsored by Key Pharmaceuticals Pty Ltd, manufactured by GOFARM Spolka z ogranniczona odpowiedzialnoscia Sp K in Poland. The device registration started on September 19, 2023.

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 IIa
ARTG 422042
Class IIa
Earwax softening otic solution
ARTG ID: 422042
Good Name: Key Pharmaceuticals Pty Ltd - Earwax softening otic solution
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Intended Purpose

Purpose of the device is to remove earwax and secretions in the external auditory canal

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
422042
Start Date
September 19, 2023
Effective Date
September 19, 2023
Manufacturer
Country
Poland
Address
ul Gornikow 21 / 26, Krakow, 30-819