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Figulla Flex II PFO Occluder Procedure Pack - Cardiac occluder

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.

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Class III
Class III
Figulla Flex II PFO Occluder Procedure Pack - Cardiac occluder
Australia TGA ARTG Registered Device
Good Name: Life Systems Medical Pty Ltd- Figulla Flex II PFO Occluder Procedure Pack - Cardiac occluder
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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.

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
Manufacturer
Country
Sweden
Address
Landskronavagen 2, Helsingborg, SE - 25232