Australia TGA ARTG record

Skin adhesive protective material

Australia TGA ARTG Registered Device · ConvaTec Australia Pty Ltd · Sion Biotext Medical Ltd · Class I · Started December 12, 2023

Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Skin adhesive protective material

Device classification

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

Registration information

Start Date: December 12, 2023
Effective Date: December 12, 2023

Sponsor

Name: ConvaTec Australia Pty Ltd

Manufacturer

Name: Sion Biotext Medical Ltd
Country: Israel
Address: 3 Eshel Street Sapirim Industrial Park, Sderot, Southern, 8701002

Intended purpose

Protective Barrier Wipes intended to protect healthy skin from friction during removal of tapesand films. It provides a thin protective layer on the skin and helps tape and film adhesion. The Protective Barrier Wipes intended for skin attachment sites: drainage tubes, external catheters, surrounding ostomy sites and other adhesive dressings. It is for use in sensitive stoma areas as a skin protectant and may reduce irritation from contact with body wastes and stoma fluid. Protective Barrier Wipes should only be used on intact skin.

About this record

Access comprehensive regulatory information for Skin adhesive protective material in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by ConvaTec Australia Pty Ltd, manufactured by Sion Biotext Medical Ltd in Israel. The device registration started on December 12, 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.