Renalyx Health Systems Pvt Ltd

Renalyx Health Systems Pvt Ltd specializes in medical devices under the Renalyx Extending Renal Care brand. These devices are primarily designed to support renal care management and patient monitoring for individuals with chronic kidney disease. They are intended for clinical use to assist in extending dialysis treatment durations or enhancing patient outcomes through integrated monitoring systems.

The company is headquartered in India, where it develops and manufactures its medical devices. Its focus on renal care solutions aligns with regulatory frameworks applicable in the country, though its devices are also registered and classified under European Union standards.

Renalyx Health Systems Pvt Ltd’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registry tracks devices that have undergone conformity assessment procedures under EU Medical Device Regulations, ensuring compliance with applicable safety and performance standards.

The company’s devices fall under Class IIb classification in the European Union. This classification is assigned based on risk assessment criteria outlined in EU Medical Device Regulations, requiring stricter conformity assessment procedures compared to lower-risk devices to ensure their safety and performance for renal care applications.