Pure Global

Negative Pressure Wound Therapy System - Irrigation negative-pressure wound therapy dressing

Access comprehensive regulatory information for Negative Pressure Wound Therapy System - Irrigation negative-pressure wound therapy dressing in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by International Medical Research Pty Ltd, manufactured by Zhejiang Longterm Medical Technology Co Ltd in China. The device registration started on June 01, 2018.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
Class IIb
Negative Pressure Wound Therapy System - Irrigation negative-pressure wound therapy dressing
Australia TGA ARTG Registered Device
Good Name: International Medical Research Pty Ltd - Negative Pressure Wound Therapy System - Irrigation negative-pressure wound therapy dressing
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The product is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include: Chronic, Acute, Traumatic, Subacute and dehisced wounds, Partial-thickness burns, Ulcers (such as diabetic or pressure), Flaps and grafts and Closed surgical incisions. This product is suitable for use in a hospital and homecare setting.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
June 01, 2018
Effective Date
June 01, 2018
Manufacturer
Country
China
Address
Huancheng North Road 493 Mo Gan Mountain National High-Tech District, Deqing, Zhejiang, 313200