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Non-sterile scar management dressing, reusable - ARTG 431512

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 registered under ARTG number 431512 and sponsored by Bare Mum Pty Ltd, manufactured by Zhongshan Kailei Personal Care Supplies Co Ltd in China. The device registration started on December 21, 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 431512
Class I
Non-sterile scar management dressing, reusable
ARTG ID: 431512
Good Name: Bare Mum Pty Ltd - Non-sterile scar management dressing, reusable
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Intended Purpose

Self-adhesive silicone gel sheets designed to occlude the skin to hydrate the scar area, prevent the formation of raised scars on healed wounds, and to be used in the management of both existing and new hypertrophic scars and keloids.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
431512
Start Date
December 21, 2023
Effective Date
December 21, 2023
Sponsor
Manufacturer
Country
China
Address
A Area 5th to 6th Floor No 4 Factory Building No 5 Simiao Road, South China Modern Traditional Chinese Medicine Yaocheng Industrial Park, Nanlang Zhongshan, Guangdong