Australia TGA ARTG record

Nail treatment solution

Australia TGA ARTG Registered Device · Arrotex Pharmaceuticals Pty Ltd · Advantice Health LLC · Class IIa · Started January 03, 2023

Good Name: Arrotex Pharmaceuticals Pty Ltd - Nail treatment solution

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: January 03, 2023
Effective Date: January 03, 2023

Sponsor

Name: Arrotex Pharmaceuticals Pty Ltd

Manufacturer

Name: Advantice Health LLC
Country: United States of America
Address: 7 East Frederick Place, Cedar Knolls, New Jersey, 07927

Intended purpose

A non-sterile topical solution in a plastic applicator with a silicone drop tip for application to nails. It promotes healing of discoloured & deformed nails (onychodystrophy) due to onychomycosis or psoriasis. It hydrates & smooths the outer layers of the nail plate & changes the nail's microenvironment (low pH, altered osmotic environment) to create an antagonistic environment for microorganisms & improves nail surface integrity, creating a barrier which prevents growth of fungi & bacteria.

About this record

Access comprehensive regulatory information for Nail treatment solution in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Arrotex Pharmaceuticals Pty Ltd, manufactured by Advantice Health LLC in United States of America. The device registration started on January 03, 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.