Australia TGA ARTG recordSurgical procedure kit, neurosurgical, single-use, non-medicated
Australia TGA ARTG Registered Device · Integra Neurosciences Pty Ltd · Integra LifeSciences Switzerland Sarl · Class I · Started May 04, 2023
Good Name: Integra Neurosciences Pty Ltd - Surgical procedure kit, neurosurgical, single-use, non-medicated
- Risk Class
- Class I
- Product Type
- Medical device system
- ARTG Category
- General-Export
- Start Date
- May 04, 2023
- Effective Date
- May 04, 2023
- Country
- Switzerland
- Address
- Floor 2 Rue Girardet 29, Le Locle, Switzerland, CH-2400
Two channel brain access system to be used as part of the Licox Brain Oxygen Monitoring System which 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.
Access comprehensive regulatory information for Surgical procedure kit, neurosurgical, single-use, non-medicated 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 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.