CardioRenal Systems, Inc.

CardioRenal Systems, Inc. develops devices focused on renal (kidney) function monitoring and management. Their portfolio includes the RenalGuard Single Use Set, a disposable device used during procedures to track kidney health, and the RenalGuard Console, a reusable system for real-time kidney perfusion and fluid balance assessment. These devices fall under Class IIa and Class IIb classifications, indicating moderate risk and requiring regulatory oversight.

CardioRenal Systems, Inc. is headquartered in the United States. While the company’s primary operations are based there, its devices are registered in the EU’s eudamed database, demonstrating compliance with European regulatory requirements. This registration reflects the company’s involvement in international markets where its products are used or distributed.

CardioRenal Systems, Inc.’s devices are listed in the eudamed database, which is the EU’s central registry for medical devices. This inclusion is necessary for transparency and traceability under EU regulations, particularly for devices marketed or used within the European Economic Area. The registry helps healthcare providers and authorities verify the manufacturer’s details and device classifications.

The company’s devices are classified as Class IIa and Class IIb under medical device regulations. Class IIa devices pose a low-to-moderate risk and require conformity assessment procedures like design examinations or clinical evaluations, while Class IIb devices carry a higher risk and may require additional testing or performance evaluations to ensure safety and effectiveness. These classifications determine the regulatory scrutiny and documentation requirements for each product.