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Intracerebral sensor catheter - ARTG 408470

Access comprehensive regulatory information for Intracerebral sensor catheter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 408470 and sponsored by Integra Neurosciences Pty Ltd, manufactured by Integra LifeSciences Switzerland Sarl in Switzerland. The device registration started on May 04, 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 408470
Class I
Intracerebral sensor catheter
ARTG ID: 408470
Good Name: Integra Neurosciences Pty Ltd - Intracerebral sensor catheter
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Intended Purpose

The Licox Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. Licox System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern. May also be used for access for intracranial pressure measurement.

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General-Export
Registration Information
ARTG ID
408470
Start Date
May 04, 2023
Effective Date
May 04, 2023
Manufacturer
Country
Switzerland
Address
Floor 2 Rue Girardet 29, Le Locle, Switzerland, CH-2400