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Bioelectrical signal processing application software

Access comprehensive regulatory information for Bioelectrical signal processing application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Compumedics Limited, manufactured by Micromed SPA in Italy. The device registration started on June 29, 2010.

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 IIb
Class IIb
Bioelectrical signal processing application software
Australia TGA ARTG Registered Device
Good Name: Compumedics Limited - Bioelectrical signal processing application software
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Intended Purpose

Xegis software is explicitly designed to help physicians in recording, archiving and reviewing data coming from Xegis digital acquisition systems. Xegis software can be used for EMG and EP exams and other neurophysiological studies based on the data recorded from the patient through Xegis acquisition devices. Some analysis functional tools are provided as default or software options. Results coming from these tools must never substitute the critical interpretation and the clinical conclusions that pertain to the physician only. Xegis software is not intended to continuously monitor the central nervous system functionality, in conditions where a warning on the change of patient condition is essential (e.g. OR and ICU automatic monitoring without the presence of the physician), since it is not endowed with proper alarms that substitute continuous medical surveillance. The use of Xegis software must always be carried out under the supervision of a physician or a qualified technician.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 29, 2010
Effective Date
June 29, 2010
Manufacturer
Country
Italy
Address
Mogliano Veneto, via Giotto 2, 31021