Australia TGA ARTG record

Bedside non-physiologic monitoring software

Australia TGA ARTG Registered Device · Emergo Asia Pacific Pty Ltd T/a Emergo Australia · Umano Medical Inc · Class Im · Started January 28, 2022

Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Bedside non-physiologic monitoring software

Device classification

Risk Class: Class Im
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: January 28, 2022
Effective Date: January 28, 2022

Sponsor

Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Name: Umano Medical Inc
Country: Canada
Address: 230 Nilus-Leclerc Boulevard, L'Islet, Quebec, G0R2C0

Intended purpose

The software is designed to electronically receive bed status data in near real-time and display status of a connected bed. Data displayed can be visualized and analyzed by care teams for fact-based assessments. Intended to inform Healthcare Professionals (HCPs) of peculiarities and preferences set by user for patient risk management, the software monitors conditions such as, but not limited to: bed status, bed configuration (height, width, angle, siderails), brakes status, bed exit, center of mass, weight logs, alarms, maintenance errors and disconnection. The software is intended to contribute to the monitoring of the fall risk prevention protocol for compliance, to assess personnel response time and, simplify maintenance in planification/logistics and decrease the bed down-time. If bed is equipped with integrated scale (measuring function), the application will display the measured data (patient weight). If bed does not have this measuring capacity, the application will not trigger this data. As a portative solution, the software is accessible from everywhere in the establishment for every registered user. The software is not designed to administer a treatment. It is not intended for Patient History Information (PHI); only weight reading (recording) is accessible.

About this record

Access comprehensive regulatory information for Bedside non-physiologic monitoring software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Im is sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by Umano Medical Inc in Canada. The device registration started on January 28, 2022.

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.