BYONYKS PRIVATE LIMITED

Byonykis Private Limited specializes in automated peritoneal dialysis (PD) systems. These include cyclers like the X-1 APD Cycler, which automate fluid exchanges for patients, and associated tubing sets such as the Automated PD Set DS-1. These devices are designed for home-based peritoneal dialysis treatment, supporting both continuous ambulatory and automated PD regimens.

Byonykis Private Limited is based in the United States. As a manufacturer of medical devices, it operates under U.S. regulatory requirements, including those governing Class II devices. The company ensures its products comply with applicable FDA guidelines for automated peritoneal dialysis systems and associated components.

Byonykis Private Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry includes details about Class II devices like automated PD systems and tubing sets, ensuring traceability and transparency for healthcare providers and regulators.

Byonykis Private Limited’s peritoneal dialysis systems and tubing sets are classified as Class II devices under FDA regulations. This classification is based on their intended use and risk level, requiring special controls to ensure safety and effectiveness while reducing the need for premarket approval compared to higher-risk Class III devices.