Australia TGA ARTG record

Figulla Flex II PFO Occluder Procedure Pack - Cardiac occluder

Australia TGA ARTG Registered Device · Life Systems Medical Pty Ltd · Occlutech International AB · Class III · Started December 08, 2022

Good Name: Life Systems Medical Pty Ltd- Figulla Flex II PFO Occluder Procedure Pack - Cardiac occluder

Device classification

Risk Class: Class III
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 08, 2022
Effective Date: December 08, 2022

Sponsor

Name: Life Systems Medical Pty Ltd

Manufacturer

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

Intended purpose

A system including an occluder (Figulla Flex II PFO) and a pusher (Flex Pusher-II). The occluder is a cardiac implant to close defects of type Patent Foramen Ovale (PFO) and is deployed using the pusher via a minimally invasive catheter delivery system.

About this record

Access comprehensive regulatory information for Figulla Flex II PFO Occluder Procedure Pack - 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 December 08, 2022.

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.