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Burn gel, non-sterile - ARTG 282333

Access comprehensive regulatory information for Burn gel, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 282333 and sponsored by AFT Pharmaceuticals Pty Ltd, manufactured by Aurena Laboratories AB in Sweden. The device registration started on November 10, 2016.

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 IIa
ARTG 282333
Class IIa
Burn gel, non-sterile
ARTG ID: 282333
Good Name: AFT Pharmaceuticals Pty Ltd - Burn gel, non-sterile
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Intended Purpose

Water-based gel for first aid treatment of minor burns, scalds, sunburn and UV-radiation injured skin. Burn Gel is intended to be used for self-care (lay-persons), at institutions or workplaces. it can be used without technical experience or training. Intended as a first aid treatment or regular treatment. The devices has been developed as a non-medicated wound spray solution with the following performance claims: -cooling effect on burns -pain relief for burns The device is intended for all ages.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
282333
Start Date
November 10, 2016
Effective Date
November 10, 2016
Manufacturer
Country
Sweden
Address
Fjarrviksvagen 22, Karlstad, SE-653 50