PulseOn PulseOn Arrhythmia Monitor System - HSA Registration DE0508937
Access comprehensive regulatory information for PulseOn PulseOn Arrhythmia Monitor System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508937 and owned by PulseOn Oy. The device was registered on February 07, 2024.
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.
The PulseOn Arrhythmia Monitor System is used to assist in the diagnosis, screening and monitoring of atrial fibrillation visible in Lead I ECG. The device is not approved for detection of other cardiac arrhythmias. The device is intended to be used inside or outside a hospital environment. The usage period of the system is two weeks, but it can be extended according to the doctor’s prescription and judgement. The PulseOn Arrhythmia Monitor System can be used in: 1. diagnosis of atrial fibrillation that is suspected on the basis of symptoms such as shortness of breath or palpitations; 2. follow-up of the effect of treatment given for atrial fibrillation; and 3. screening of atrial fibrillation, e.g. in the general population.