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Non-sterile scar management dressing, reusable

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 Aero Healthcare, manufactured by Huizhou Foryou Medical Devices Co Ltd in China. The device registration started on March 22, 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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Class I
Class I
Non-sterile scar management dressing, reusable
Australia TGA ARTG Registered Device
Good Name: Aero Healthcare - Non-sterile scar management dressing, reusable
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Intended Purpose

Temporary use in the management of both existing and new hypertrophic or keloid scars. Temporary use as a prophylactic treatment on closed wounds to prevent hypertrophic or keloid scarring. Do not use on open wounds.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 22, 2023
Effective Date
March 22, 2023
Sponsor
Manufacturer
Country
China
Address
North Shangxia Rd Dongjiang Hi-tech Industry Park, HuiZhou, 516005