Pure Global

Training aid, cognitive test equipment, <specify>

Access comprehensive regulatory information for Training aid, cognitive test equipment, <specify> in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Brainlab Australia Pty Ltd, manufactured by Brainlab Ltd in Israel. The device registration started on January 04, 2018.

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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TGA ARTG Official Data
Class I
Class I
Training aid, cognitive test equipment, <specify>
Australia TGA ARTG Registered Device
Good Name: Brainlab Australia Pty Ltd - Training aid, cognitive test equipment, <specify>
Pure Global
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Intended Purpose

This application is intended to be used directly by the patient at the advice of their healthcare provider. It contains a set of tasks that will generate useful data about some of the patient's cognitive skills. The data will help the healthcare provider to monitor and track potential changes in the results of these tasks and identify if these changes may potentially require further formal investigation. The results should only be interpreted by a healthcare provider. This application is not intended for diagnosis nor to replace a formal neuropsychological/neurocognitive evaluation.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
January 04, 2018
Effective Date
January 04, 2018
Manufacturer
Country
Israel
Address
35 Efal Street, Petach-Tikva, 4951132