Bittium Faros - HSA Registration DE0510221
Access comprehensive regulatory information for Bittium Faros in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510221 and owned by Bittium Biosignals Ltd. The device was registered on January 08, 2025.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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 sensor 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 Biosignals Ltd. 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.