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Earwax softening oil - ARTG 430902

Access comprehensive regulatory information for Earwax softening oil in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 430902 and sponsored by NOUMED PHARMACEUTICALS PTY LTD, manufactured by GOFARM Spolka z ogranniczona odpowiedzialnoscia Sp K in Poland. The device registration started on December 15, 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 I
ARTG 430902
Class I
Earwax softening oil
ARTG ID: 430902
Good Name: NOUMED PHARMACEUTICALS PTY LTD - Earwax softening oil
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Intended Purpose

The device is a spray used to dissolve and remove residual earwax and moisturize the ear canal. The preparation is used to clear the ear canal of secretions, manifested by itching or reddening of the skin of the ear canal with little or no swelling. Peppermint oil is used to provide a pleasant smell. Peppermint oil has no pharmacological effect.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
430902
Start Date
December 15, 2023
Effective Date
December 15, 2023
Manufacturer
Country
Poland
Address
ul Gornikow 21 / 26, Krakow, 30-819