ARTG 388350Electrocardiographic long-term ambulatory recorder, telemetric
ARTG ID: 388350 · CardioNexus Imaging Pty Ltd · Bittium Biosignals Ltd · Class IIa · Started May 12, 2022
Good Name: CardioNexus Imaging Pty Ltd - Electrocardiographic long-term ambulatory recorder, telemetric
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 388350
- Start Date
- May 12, 2022
- Effective Date
- May 12, 2022
- Country
- Finland
- Address
- Pioneerinkatu 6, Kuopio, FI, 70800
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 analyzed 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 pediatric 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.
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 registered under ARTG number 388350 and sponsored by CardioNexus Imaging Pty Ltd, manufactured by Bittium Biosignals Ltd in Finland. The device registration started on May 12, 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.