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SOFIA EX Catheter - Catheter, intravascular, guiding - ARTG 477565

Access comprehensive regulatory information for SOFIA EX Catheter - Catheter, intravascular, guiding in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 477565 and sponsored by Life Healthcare Pty Ltd, manufactured by MicroVention Europe SARL in France. The device registration started on February 03, 2025.

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
ARTG 477565
Class III
SOFIA EX Catheter - Catheter, intravascular, guiding
ARTG ID: 477565
Good Name: Life Healthcare Pty Ltd - SOFIA EX Catheter - Catheter, intravascular, guiding
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Intended Purpose

The SOFIA EX Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents or therapeutic devices. It is not intended for use in coronary arteries.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
477565
Start Date
February 03, 2025
Effective Date
February 03, 2025
Manufacturer
Country
France
Address
30 bis rue du Vieil Abreuvoir, Saint-Germain-en-Laye, 78100