Pure Global

SOFIA Plus Catheter - Embolectomy/thrombectomy suction catheter

Access comprehensive regulatory information for SOFIA Plus Catheter - Embolectomy/thrombectomy suction catheter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Culpan Medical Pty Ltd, manufactured by MicroVention Europe SARL in France. The device registration started on March 29, 2017.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class III
Class III
SOFIA Plus Catheter - Embolectomy/thrombectomy suction catheter
Australia TGA ARTG Registered Device
Good Name: Culpan Medical Pty Ltd - SOFIA Plus Catheter - Embolectomy/thrombectomy suction catheter
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The SOFIAโ„ข Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIAโ„ข Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. The SOFIAโ„ข Catheter is not intended for use in coronary arteries. Moreover, the SOFIAโ„ข Catheter is intended for use in removal/aspiration of emboli and thrombi from selected blood vessels in the arterial system, including the peripheral and neuro vasculatures

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 29, 2017
Effective Date
March 29, 2017
Manufacturer
Country
France
Address
30 bis rue du Vieil Abreuvoir, Saint-Germain-en-Laye, 78100