Cardio Sistemas Comercial e Industrial Ltda

Cardio Sistemas Comercial e Industrial Ltda manufactures ambulatory cardiac monitoring devices. This includes Holter ECG recorders like the CardioSmart CS550 (available in French, Spanish, and English versions) for continuous heart rhythm monitoring, as well as ambulatory blood pressure monitoring systems such as the CardioLight+. Additionally, they produce patient cables (e.g., Patient Cable CL 4 Leads) designed for multi-lead ECG attachments, supporting diagnostic procedures in cardiology.

The company is based in Brazil. Its focus on ambulatory cardiac monitoring devices aligns with regional and global demand for portable diagnostic tools, particularly in markets where long-term cardiac monitoring is critical for patient management.

The devices produced by Cardio Sistemas Comercial e Industrial Ltda are listed in the eudamed database, which is the European Union’s central registry for medical devices. This inclusion indicates compliance with EU regulatory requirements for device traceability and transparency, though it does not imply approval or clearance of individual devices.

The devices manufactured by Cardio Sistemas Comercial e Industrial Ltda fall under Class IIa classification in the EU. This classification is assigned based on the risk associated with the device’s intended use—Class IIa devices pose a moderate risk and require compliance with specific EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements, including clinical evaluations and conformity assessments.