Australia TGA ARTG record

Electrocardiograph, Holter analyser, software

Australia TGA ARTG Registered Device · Quintessa Holdings Pty Ltd · Coala-Life AB · Class IIa · Started July 09, 2020

Good Name: Quintessa Holdings Pty Ltd - Electrocardiograph, Holter analyser, software

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: July 09, 2020
Effective Date: July 09, 2020

Sponsor

Name: Quintessa Holdings Pty Ltd

Manufacturer

Name: Coala-Life AB
Country: Sweden
Address: Riddargarton 18, Stockholm, 11451

Intended purpose

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

About this record

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 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.