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Occlutech PDA Occluder / Occlutech Occlusions-Pusher - Cardiac occluder - ARTG 434731

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 registered under ARTG number 434731 and 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.

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TGA ARTG Official Data
Class III
ARTG 434731
Class III
Occlutech PDA Occluder / Occlutech Occlusions-Pusher - Cardiac occluder
ARTG ID: 434731
Good Name: Life Systems Medical Pty Ltd - Occlutech PDA Occluder / Occlutech Occlusions-Pusher - Cardiac occluder
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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).

Device Classification
Risk Class
Class III
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
434731
Start Date
January 17, 2024
Effective Date
January 17, 2024
Manufacturer
Country
Sweden
Address
Landskronavagen 2, Helsingborg, SE - 25232