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Patient monitor system

Access comprehensive regulatory information for Patient monitor system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia, manufactured by Guangdong Biolight Meditech Co Ltd in China. The device registration started on April 15, 2020.

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
Patient monitor system
Australia TGA ARTG Registered Device
Good Name: The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia - Patient monitor system
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Intended Purpose

Patient monitors are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG(3-lead or 5-lead or 12-lead selectable),arrhythmia detection,ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP),Carbon dioxide (CO2), Anesthetic Gas (AG). The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician. It is not intended for helicopter tansport, hospital ambulance, or home use.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
April 15, 2020
Effective Date
April 15, 2020
Manufacturer
Country
China
Address
No 2 Innovation First Road Technical Innovation Coast Hi-tech Zone, Zhuhai, Guangdong, 519085