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Aquacel Ag+ Extra Hydrofiber Dressing with Silver and Strengthening Fibre - Dressing, highly-absorbent, hydrophilic gel-forming, antimicrobial

Access comprehensive regulatory information for Aquacel Ag+ Extra Hydrofiber Dressing with Silver and Strengthening Fibre - Dressing, highly-absorbent, hydrophilic gel-forming, antimicrobial in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by ConvaTec Australia Pty Ltd, manufactured by Convatec Limited in United Kingdom. The device registration started on March 21, 2022.

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 III
Class III
Aquacel Ag+ Extra Hydrofiber Dressing with Silver and Strengthening Fibre - Dressing, highly-absorbent, hydrophilic gel-forming, antimicrobial
Australia TGA ARTG Registered Device
Good Name: ConvaTec Australia Pty Ltd - Aquacel Ag+ Extra Hydrofiber Dressing with Silver and Strengthening Fibre - Dressing, highly-absorbent, hydrophilic gel-forming, antimicrobial
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Intended Purpose

AQUACEL Ag+ EXTRA Hydrofiber Dressing may be used for the management of: • wounds as a barrier to bacterial penetration of the dressing as this may help reduce infection; • wounds where there is an infection or an increased risk of infection; • diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness); • surgical wounds; • traumatic wounds; • wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided; • oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi’s sarcoma, and angiosarcoma. • partial thickness (second degree) burns • wounds where bacteria are a suspected cause of (or a factor in) chronicity/non-progression.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 21, 2022
Effective Date
March 21, 2022
Manufacturer
Country
United Kingdom
Address
Unit 20 1st Avenue Deeside Industrial Park, Deeside, Flintshire, CH5 2NU