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Neural-tissue balloon catheter - ARTG 410655

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 registered under ARTG number 410655 and 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.

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Class I
ARTG 410655
Class I
Neural-tissue balloon catheter
ARTG ID: 410655
Good Name: Integra Neurosciences Pty Ltd - Neural-tissue balloon catheter
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Intended Purpose

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

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General-Export
Registration Information
ARTG ID
410655
Start Date
June 15, 2023
Effective Date
June 15, 2023
Manufacturer
Country
Switzerland
Address
Rue Girardet 29 Second Floor, Le Locle Neuchatel, Ch-2400