Corify Care S.L

Corify Care S.L manufactures medical devices primarily used in cardiac care, including the Acorys Mapping System for cardiac mapping and the Acsen-SC and Acsen-EA devices. These products are designed to assist in precise diagnostic and procedural applications within the cardiovascular field.

Corify Care S.L is based in Spain. Its devices are listed in the EUDAMED database for European Union regulatory tracking and have also received FDA 510(k) clearance, indicating compliance with U.S. regulatory requirements for medical devices.

The devices produced by Corify Care S.L fall into Class I and Class II categories under medical device regulations. Classification is determined by factors like the device’s intended use, risk level, and potential impact on patient safety, with Class II devices typically involving moderate risk that requires additional regulatory oversight.

Yes, Corify Care S.L’s devices are authorised in both the European Union (via EUDAMED listing) and the United States (via FDA 510(k) clearance). This dual listing reflects compliance with separate regulatory frameworks, ensuring the devices meet the safety and performance standards required in each market.