Australia TGA ARTG record

Occlutech PDA Occluder / Occlutech Occlusions-Pusher - Cardiac occluder

Australia TGA ARTG Registered Device · Life Systems Medical Pty Ltd · Occlutech International AB · Class III · Started January 17, 2024

Good Name: Life Systems Medical Pty Ltd - Occlutech PDA Occluder / Occlutech Occlusions-Pusher - Cardiac occluder

Device classification

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

Registration information

Start Date: January 17, 2024
Effective Date: January 17, 2024

Sponsor

Name: Life Systems Medical Pty Ltd

Manufacturer

Name: Occlutech International AB
Country: Sweden
Address: Landskronavagen 2, Helsingborg, SE - 25232

Intended purpose

The Occlutech PDA Occluder is an occlusion system, which is percutaneously implanted through a catheter intervention technique and intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA).

About this record

Access comprehensive regulatory information for Occlutech PDA Occluder / Occlutech Occlusions-Pusher - Cardiac occluder in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Life Systems Medical Pty Ltd, manufactured by Occlutech International AB in Sweden. The device registration started on January 17, 2024.

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.