POWERFUL MEDICAL s.r.o.

Powerful Medical s.r.o. specialises in AI-powered electrocardiogram (ECG) devices. These include systems designed for real-time ECG interpretation, automated analysis, and clinical decision support, such as the PMcardio® OMI AI ECG Model and PMcardio® Core AI ECG Model. Their products focus on acute ECG interpretation, screening, monitoring, and coordination of cardiac care pathways.

Powerful Medical s.r.o. is headquartered in Slovakia. The company operates within the European Union, where its devices must comply with EU regulatory standards for medical device authorisation.

Powerful Medical’s devices are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of devices authorised under EU regulations.

Powerful Medical’s ECG devices fall under the EU Class IIb classification. This classification is assigned based on the risk associated with the device, with Class IIb indicating a moderate to high risk that requires stringent regulatory oversight to ensure safety and performance.