ARTG 370873

Interpretive multichannel electrocardiograph

ARTG ID: 370873 · Medeleq Australia Pty Ltd · Shenzhen Carewell Electronics Co Ltd · Class IIa · Started July 12, 2021

Good Name: Medeleq Australia Pty Ltd - Interpretive multichannel electrocardiograph

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

Sponsor

Name: Medeleq Australia Pty Ltd

Manufacturer

Name: Shenzhen Carewell Electronics Co Ltd
Country: China
Address: Floor 4 BLD 9 Baiwangxin High-Tech Industrial Park Songbai Road Xili Street, Nanshan District, Shenzhen, 518108

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.

About this record

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.