Australia TGA ARTG record

Drainage bag

Australia TGA ARTG Registered Device · EMT Healthcare Pty Ltd · Innoventa Medica ApS · Class Is · Started April 13, 2023

Good Name: EMT Healthcare Pty Ltd - Drainage bag

Device classification

Risk Class: Class Is
Product Type: Procedure Pack
ARTG Category: General

Registration information

Start Date: April 13, 2023
Effective Date: April 13, 2023

Sponsor

Name: EMT Healthcare Pty Ltd

Manufacturer

Name: Innoventa Medica ApS
Country: Denmark
Address: Blokken 45, Birkerod, DK-3460

Intended purpose

A sterile container designed to collect fluids or purulent material being removed during drainage of a closed-wound; it is not intended for drainage of cerebrospinal fluid or blood. A low negative pressure produced by a hand-operated pump connected to the reservoir assists the drainage function. This device is in the form of a plastic bottle and includes a hand-operated handpiece (pump); it does not include any invasive components or powered devices. This is a single-use device.

About this record

Access comprehensive regulatory information for Drainage bag in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by EMT Healthcare Pty Ltd, manufactured by Innoventa Medica ApS in Denmark. The device registration started on April 13, 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.