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Sterile wound irrigation solution - ARTG 282334

Access comprehensive regulatory information for Sterile wound irrigation solution in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 282334 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 IIb
ARTG 282334
Class IIb
Sterile wound irrigation solution
ARTG ID: 282334
Good Name: AFT Pharmaceuticals Pty Ltd - Sterile wound irrigation solution
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Intended Purpose

A sterile solution of sodium chloride (NaCl), sometimes with additional compounds, intended to be used to irrigate and clean a wound to aid in autolytic debridement, and to moisten/lubricate a wound dressing; it is not intended to provide antimicrobial activity. The device may be available as a liquid or a spray. After application, this device cannot be reused.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
282334
Start Date
November 10, 2016
Effective Date
November 10, 2016
Manufacturer
Country
Sweden
Address
Fjarrviksvagen 22, Karlstad, SE-653 50