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VitalSignum procedure pack, consisting of Beat2Phone ECG sensor and Cardiolyse ECG analyzing SW, has been assessed the notified body 0598 and been found to be in conformity with regulations - SGS Fimko decision FI21/07061P0. Beat2Phone ECG service provides a seamless transfer of recordings to the analysis SW returning annotations to the cloud storage to be viewed for any chosen ECG recording. The service facilitates efficient professional analysis of several days of high quality Beat2Phone ECG monitoring records through the markings added by the analysis algorithm. The service is available for users by purchasing the 1,6 or 12 month license from VitalSignum. FI21_07061P0 - VitalSignum Oy - MDD EC Certification Decision - 2021-05-25...
VitalSignum received the Medical CE Certificate for Medical Devices for Beat2Phone ECG recorder. The management system of VitalSignum was also assessed and certified as meeting the requirements of ISO 13485. Link to the Medical CE certificate FI20_871798 Iss1 VitalSignum Oy MDD EC certificate 2020-2024 Link to the ISO 13485 certificate VitalSignum ISO 13485 2020-2023...