CARDIO CALM SRL

Cardio Calm SRL specializes in developing software applications for electrocardiographic long-term ambulatory recording analysis. These tools are designed to process and interpret continuous heart rhythm data collected over extended periods, helping clinicians monitor cardiac activity outside traditional clinical settings.

Cardio Calm SRL is based in the United States. The company’s focus is on developing software solutions for cardiac monitoring, aligning with regulatory frameworks in the US market.

Cardio Calm SRL’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring transparency and traceability in the healthcare supply chain.

Cardio Calm SRL’s devices fall under FDA’s Class II classification. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as software for electrocardiographic analysis, which requires validation and performance testing.