Australia TGA ARTG record

Neural-tissue balloon catheter

Australia TGA ARTG Registered Device · Integra Neurosciences Pty Ltd · Integra LifeSciences Switzerland Sarl · Class I · Started June 15, 2023

Good Name: Integra Neurosciences Pty Ltd - Neural-tissue balloon catheter

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General-Export

Registration information

Start Date: June 15, 2023
Effective Date: June 15, 2023

Sponsor

Name: Integra Neurosciences Pty Ltd

Manufacturer

Name: Integra LifeSciences Switzerland Sarl
Country: Switzerland
Address: Rue Girardet 29 Second Floor, Le Locle Neuchatel, Ch-2400

Intended purpose

The NeuroBalloon Catheter is intended for dilatation of cerebral membrane fenestrations under direct or endoscopic visualization during intracranial procedures.

About this record

Access comprehensive regulatory information for Neural-tissue balloon catheter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Integra Neurosciences Pty Ltd, manufactured by Integra LifeSciences Switzerland Sarl in Switzerland. The device registration started on June 15, 2023.

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.