Singapore HSA registration DE0508937
PulseOn PulseOn Arrhythmia Monitor System
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0508937
- Registration Date
- February 07, 2024
- Change Notification Approval Date
- September 16, 2024
- Retention Due Date
- February 06, 2026
Product description
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.
Product Owner
- Name
- PulseOn Oy
- Short Name
- PulseOn Oy
- Address
- Tekniikantie 12, 02150 Espoo,, FINLAND
Registrant
- Address
- 625 ALJUNIED ROAD, ALJUNIED INDUSTRIAL COMPLEX, #04-05A, SINGAPORE 389836
Importer
- Name
- BMEC PTE LTD
- Address
- 82 UBI AVENUE 4, EDWARD BOUSTEAD CENTRE, #08-01, SINGAPORE 408832
Model information
- Model Name(s)
- PulseOn Arrhythmia monitor PulseOn Arrhythmia Monitor System Data Management Service Data Transfer Software
- Model Identifier(s)
- AM-1 AMS-1 DMS DTS
About this record
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.
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