Australia TGA ARTG record

Multi-purpose saline solution

Australia TGA ARTG Registered Device · AFT Pharmaceuticals Pty Ltd · Aurena Laboratories AB · Class IIa · Started December 05, 2023

Good Name: AFT Pharmaceuticals Pty Ltd - Multi-purpose saline solution

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 05, 2023
Effective Date: December 05, 2023

Sponsor

Name: AFT Pharmaceuticals Pty Ltd

Manufacturer

Name: Aurena Laboratories AB
Country: Sweden
Address: Fjarrviksvagen 22, Karlstad, SE-653 50

Intended purpose

Sterile isotonic saline solution for rinsing/cleansing of wounds. The device is intended to be used for self-care, at institutions or workplaces. It can be used without technical experience or training. The spray has been developed as a non-medicated wound spray to: -to be used on acute and chronic wounds and pin sites to be cleansed -to softens debris and eschar to enable removal -to provide a gentle way of removing debris, eschar, pus, and slough from a wound cavity -to cleanse wounds and thereby supports wound healing The device is for all ages.

About this record

Access comprehensive regulatory information for Multi-purpose saline solution in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by AFT Pharmaceuticals Pty Ltd, manufactured by Aurena Laboratories AB in Sweden. The device registration started on December 05, 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.