Australia TGA ARTG record

Electrocardiographic long-term ambulatory recorder, telemetric

Australia TGA ARTG Registered Device · Cloudholter Pty Ltd · Bittium Biosignals Ltd · Class IIa · Started April 26, 2022

Good Name: Cloudholter Pty Ltd - Electrocardiographic long-term ambulatory recorder, telemetric

Device classification

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

Registration information

Start Date: April 26, 2022
Effective Date: April 26, 2022

Sponsor

Name: Cloudholter Pty Ltd

Manufacturer

Name: Bittium Biosignals Ltd
Country: Finland
Address: Pioneerinkatu 6, Kuopio, FI, 70800

Intended purpose

Faros device is an ambulatory recorder and transmitter for ECG and motion (accelerometer) data. Faros can perform ECG measurement, R-R interval data measurement and capture patient motion. All data is recorded to device internal memory. Faros device monitors patient ECG and generates event markers using the in-built arrhythmia detection algorithms. Data recorded by the device can be analysed by other processing systems to provide reports or transferred via Bluetooth to companion systems for further analysis. These systems can be either third party systems or designed, maintained and/or owned by Bittium. Faros device is intended for adult and paediatric patients who require vital sign monitoring inside or outside hospital or healthcare facility environment. Faros device does not provide interpretive statements. Final interpretation and diagnosis is the responsibility of a physician.

About this record

Access comprehensive regulatory information for Electrocardiographic long-term ambulatory recorder, telemetric in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Cloudholter Pty Ltd, manufactured by Bittium Biosignals Ltd in Finland. The device registration started on April 26, 2022.

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.