Australia flagARTG 467345

Interpretive multichannel electrocardiograph

ARTG ID: 467345 · Cloudholter Pty Ltd · Edan Instruments Inc · Class IIb · Started November 05, 2024

Good Name: Cloudholter Pty Ltd - Interpretive multichannel electrocardiograph

Device classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
467345
Start Date
November 05, 2024
Effective Date
November 05, 2024
Sponsor
Manufacturer
Country
China
Address
#15 Jinhui Road Jinsha Community Kengzi Sub-District Pingshan District, Shenzhen, 518122
Intended purpose

Intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes and provide cardiogram measurements and interpretive statements to clinicians for consideration when analyzing and diagnosing heart disease.

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 IIb is registered under ARTG number 467345 and sponsored by Cloudholter Pty Ltd, manufactured by Edan Instruments Inc in China. The device registration started on November 05, 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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