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Synthetic polymer burn dressing, non-coated - ARTG 403963

Access comprehensive regulatory information for Synthetic polymer burn dressing, non-coated in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 403963 and sponsored by St John Ambulance Australia Inc, manufactured by Shaoxing Fuqing Health Products Co Ltd in China. The device registration started on January 30, 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 Is
ARTG 403963
Class Is
Synthetic polymer burn dressing, non-coated
ARTG ID: 403963
Good Name: St John Ambulance Australia Inc - Synthetic polymer burn dressing, non-coated
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Intended Purpose

A sterile covering designed to be applied over a burn typically in an emergency situation to prevent burn progression and protect against infection. It is available in various sizes and is intended to treat small to large patient burns. It is made of synthetic polymer materials and is not impregnated with a gel coating. It is for single-use only.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
403963
Start Date
January 30, 2023
Effective Date
January 30, 2023
Manufacturer
Country
China
Address
No. 599 Wuxie Road High-Tech Industrial Development Zone , Shaoxing , Zhejiang, 312000