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Drainage bag

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.

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TGA ARTG Official Data
Class Is
Class Is
Drainage bag
Australia TGA ARTG Registered Device
Good Name: EMT Healthcare Pty Ltd - Drainage bag
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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.

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
Manufacturer
Country
Denmark
Address
Blokken 45, Birkerod, DK-3460