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FRED X Flow Re-Direction Endoluminal Device - Stent, vascular, intracranial

Access comprehensive regulatory information for FRED X Flow Re-Direction Endoluminal Device - Stent, vascular, intracranial in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Life Healthcare Pty Ltd, manufactured by MicroVention Europe SARL in France. The device registration started on January 03, 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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Class III
Class III
FRED X Flow Re-Direction Endoluminal Device - Stent, vascular, intracranial
Australia TGA ARTG Registered Device
Good Name: Life Healthcare Pty Ltd - FRED X Flow Re-Direction Endoluminal Device - Stent, vascular, intracranial
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Intended Purpose

The FRED X System is intended for endovascular embolization of intracranial neurovascular aneurysms. The FRED X System may also be used with embolic coils for the treatment of intracranial neurovascular lesions.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
January 03, 2024
Effective Date
January 03, 2024
Manufacturer
Country
France
Address
30 bis rue du Vieil Abreuvoir, Saint-Germain-en-Laye, 78100