Australia TGA ARTG record

Negative-pressure wound therapy system, battery-powered, single-use

Australia TGA ARTG Registered Device · Molnlycke Health Care Pty Ltd · Molnlycke Health Care AB · Class I · Started November 23, 2023

Good Name: Molnlycke Health Care Pty Ltd - Negative-pressure wound therapy system, battery-powered, single-use

Device classification

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

Registration information

Start Date: November 23, 2023
Effective Date: November 23, 2023

Sponsor

Name: Molnlycke Health Care Pty Ltd

Manufacturer

Name: Molnlycke Health Care AB
Country: Sweden
Address: Gamlestadsvagen 3C Box 13080, Goteburg, SE-402 52

Intended purpose

The Avance® Solo Carrier Case is intended to be used with Avance® Solo NPWT System as an accessory. The Avance® Solo Carrier Case enables an easy way to carry the pump when needed and decreases the cycling sound of the pump during operation.

About this record

Access comprehensive regulatory information for Negative-pressure wound therapy system, battery-powered, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Molnlycke Health Care Pty Ltd, manufactured by Molnlycke Health Care AB in Sweden. The device registration started on November 23, 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.