Australia TGA ARTG record

Bioelectrical signal processing application software

Australia TGA ARTG Registered Device · Compumedics Limited · Micromed SPA · Class IIb · Started June 29, 2010

Good Name: Compumedics Limited - Bioelectrical signal processing application software

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

Sponsor

Name: Compumedics Limited

Manufacturer

Name: Micromed SPA
Country: Italy
Address: Mogliano Veneto, via Giotto 2, 31021

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.

About this record

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.