Australia TGA ARTG recordNon-sterile scar management dressing, reusable
Australia TGA ARTG Registered Device · Total Patient Care Pty Ltd · Biodermis · Class I · Started May 22, 2013
Good Name: Total Patient Care Pty Ltd - Non-sterile scar management dressing, reusable
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- May 22, 2013
- Effective Date
- May 22, 2013
- Name
- Biodermis
- Country
- United States of America
- Address
- 1820 Whitney Mesa Drive Suite 100 Henderson, Nevada, 89014
A non-sterile covering made of a silicone-based material (e.g., silicone gel) that is applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device.
Access comprehensive regulatory information for Non-sterile scar management dressing, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Total Patient Care Pty Ltd, manufactured by Biodermis in United States of America. The device registration started on May 22, 2013.
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.