Singapore HSA registration DE0508937

PulseOn PulseOn Arrhythmia Monitor System

Singapore flagSingapore·CLASS B·PulseOn Oy·Registered February 07, 2024
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
Short Name
PulseOn Oy
Address
Tekniikantie 12, 02150 Espoo,, FINLAND
Registrant
Address
625 ALJUNIED ROAD, ALJUNIED INDUSTRIAL COMPLEX, #04-05A, SINGAPORE 389836
Importer
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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