Cardiolex Medical AB

Cardiolex Medical AB specializes in electrocardiogram (ECG) monitoring devices and systems. Their portfolio includes standalone ECG devices like the EC Sense and EC View, as well as integrated solutions such as the EC Sense System and the Decapus III. These products are designed for clinical and diagnostic use in assessing cardiac function.

Cardiolex Medical AB is headquartered in Solna, Sweden. The company focuses on developing and marketing ECG devices and ECG management systems, with a mission to create products that are reliable and easy to use for healthcare professionals.

Cardiolex Medical AB’s devices are registered in the EU’s eudamed database, which is the official EU registry for medical devices. This registration ensures transparency and compliance with EU Medical Device Regulations for their listed products.

Cardiolex Medical AB’s devices fall under Class I and Class IIa classifications according to the EU Medical Device Regulations. The classification is determined by factors like the device’s intended use, risk level, and potential impact on patient safety, with Class IIa indicating a moderate risk requiring additional regulatory scrutiny.