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Patient monitor module, multifunction - ARTG 466611

Access comprehensive regulatory information for Patient monitor module, multifunction in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 466611 and sponsored by Intermed Medical Pty Ltd, manufactured by Schiller AG in Switzerland. The device registration started on October 31, 2024.

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
ARTG 466611
Class IIb
Patient monitor module, multifunction
ARTG ID: 466611
Good Name: Intermed Medical Pty Ltd - Patient monitor module, multifunction
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Intended Purpose

The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical System (Host System) for acquiring, analyzing, and transmission of patient vitals and other pertinent clinical data of following vital data of a patient: ECG and Respiration: ECG, heart rate, asystole time, respiration rate and apnea time for monitoring and diagnostic purpose. IBP: The IBP measurement is intended for continuously invasive measurement of a patientโ€™s arterial and/or venous blood pressure in different locations. NIBP: The NIBP measurement is intended for non-invasive measure blood pressure with different cuffs in different locations SpO2: The SpO2 measurement is intended for non-invasive measuring of a patientโ€™s oxygen saturation level and other parameters (e.g. SpCO, SpMet). CO2 and Respiration: The CO2 measurement is intended for the non-invasive monitoring of a patientโ€™s in and exhaled carbon dioxide, anesthesia gases and to provide a respiration rate. Cardiac Output (CO): The Cardiac Output measurement is intended for measuring continuously blood and injected fluid temperature for calculating the current Cardiac Output of a patient in the medical system (Host System). Temperature: The Temperature measurement is intended for non-invasive and invasive measurement of a patientโ€™s temperature in different locations.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
466611
Start Date
October 31, 2024
Effective Date
October 31, 2024
Manufacturer
Country
Switzerland
Address
Altgasse 68, Baar, 6341