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- - Arrythmia-detection blood pressure ambulatory recorder - ARTG 355753

Access comprehensive regulatory information for - - Arrythmia-detection blood pressure ambulatory recorder in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 355753 and sponsored by Life Systems Medical Pty Ltd, manufactured by Microlife Corporation in Taiwan. The device registration started on February 26, 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 IIa
ARTG 355753
Class IIa
- - Arrythmia-detection blood pressure ambulatory recorder
ARTG ID: 355753
Good Name: Life Systems Medical Pty Ltd - - - Arrythmia-detection blood pressure ambulatory recorder
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Intended Purpose

A non-invasive 24 hour ambulatory blood pressure monitor (ABPM) using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for or use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm. The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia. The device provides aortic blood pressure parameters, includes central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff. The device detects the appearance of atrial fibrillation during measurement. The memory data can be transferred to the PC running dedicated software. The device incorporates the monitor, cuffs with connection tubing.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
355753
Start Date
February 26, 2021
Effective Date
February 26, 2021
Manufacturer
Country
Taiwan
Address
9F 431 RuiGuang Road, Nei Hu, Taipei, 11492