Australia TGA ARTG record

Nail treatment solution

Australia TGA ARTG Registered Device · Actor Pharmaceuticals Pty Ltd · Oystershell NV · Class IIa · Started October 20, 2018

Good Name: Actor Pharmaceuticals Pty Ltd - Nail treatment solution

Device classification

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

Registration information

Start Date: October 20, 2018
Effective Date: October 20, 2018

Sponsor

Name: Actor Pharmaceuticals Pty Ltd

Manufacturer

Name: Oystershell NV
Country: Belgium
Address: Nijverheidsweg 10, Merelbeke, 9820

Intended purpose

A non-sterile topical solution designed to treat infected nails (e.g.,onychomycosis) and nail-growth disorders (onychodystrophy) by creating a barrier to and an antagonistic environment for microorganisms. The solution is delivered onto the nail plate, which will penetrate through, and is applied until a completely healthy nail has grown. It controls the microenvironment of the nail by acidifying the nail bed; contains acidic substances that are able to penetrate the nail and permit treatment from the inside out; and immediately lowers the pH of the nail, creating an environment that is hostile to fungal growth.

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 Actor Pharmaceuticals Pty Ltd, manufactured by Oystershell NV in Belgium. The device registration started on October 20, 2018.

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.