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Electrocardiograph, Holter analyser, software - ARTG 339240

Access comprehensive regulatory information for Electrocardiograph, Holter analyser, software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 339240 and sponsored by Quintessa Holdings Pty Ltd, manufactured by Coala-Life AB in Sweden. The device registration started on July 09, 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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TGA ARTG Official Data
Class IIa
ARTG 339240
Class IIa
Electrocardiograph, Holter analyser, software
ARTG ID: 339240
Good Name: Quintessa Holdings Pty Ltd - Electrocardiograph, Holter analyser, software
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Intended Purpose

A stand-alone web-based software for Healthcare professionals to review ECG and heart sound recording.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
339240
Start Date
July 09, 2020
Effective Date
July 09, 2020
Manufacturer
Country
Sweden
Address
Riddargarton 18, Stockholm, 11451