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Welch Allyn Connex Integrated Wall System - Single-patient physiologic monitoring system

Access comprehensive regulatory information for Welch Allyn Connex Integrated Wall System - Single-patient physiologic monitoring system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Welch Allyn Australia Pty Limited, manufactured by Welch Allyn Inc in United States of America. The device registration started on September 27, 2021.

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
Welch Allyn Connex Integrated Wall System - Single-patient physiologic monitoring system
Australia TGA ARTG Registered Device
Good Name: Welch Allyn Australia Pty Limited - Welch Allyn Connex Integrated Wall System - Single-patient physiologic monitoring system
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Intended Purpose

The Welch Allyn Connex® Integrated Wall System is a stationery (wall-installed) version of the Welch Allyn CVSM 6000 series of monitors intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for noninvasive blood pressure (NIBP), pulse rate (PR), noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) and body temperature in normal and axillary modes. The optional Masimo rainbow® SET Pulse CO-Oximeter™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), total hemoglobin concentration (SpHb®), and/or respiration rate (RRa™). The Masimo rainbow SET Radical-7R™ Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion and no-motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
September 27, 2021
Effective Date
September 27, 2021
Manufacturer
Country
United States of America
Address
4341 State Street Road, SKANEATELES FALLS, NY, 13153