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Interpretive multichannel electrocardiograph - ARTG 370873

Access comprehensive regulatory information for Interpretive multichannel electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 370873 and sponsored by Medeleq Australia Pty Ltd, manufactured by Shenzhen Carewell Electronics Co Ltd in China. The device registration started on July 12, 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 370873
Class IIa
Interpretive multichannel electrocardiograph
ARTG ID: 370873
Good Name: Medeleq Australia Pty Ltd - Interpretive multichannel electrocardiograph
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Intended Purpose

Digital 12-channel physiological function measurement equipment which records the heart waveform during electro-biological movement. It provides sufficient information on the analysis of arrhythmia and cardiovascular disease, helps to know the pathological disorder caused by some drugs and electrolyte, or unbalance of PH value. It is important equipment for cardiac disease examination, and its compact size makes it suitable for use while visiting patients at home. Intended use: The cardiogram and heart rate recorded by the ECG can help doctors to analyze and diagnose heart disease or arrhythmia in hospitals. Its compact size makes it suitable for use while visiting patients at home. It is suitable for Adults.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
370873
Start Date
July 12, 2021
Effective Date
July 12, 2021
Manufacturer
Country
China
Address
Floor 4 BLD 9 Baiwangxin High-Tech Industrial Park Songbai Road Xili Street, Nanshan District, Shenzhen, 518108