Organox Limited

Organox Limited specializes in devices for liver donor-organ preservation and transport. Their products include perfusion circuits (like the metra Liver Perfusion Circuit Pack) and complete perfusion systems (such as the OrganOx metra® System). These systems are designed to maintain organ viability during transport from donation to transplantation by simulating physiological conditions, ensuring the liver remains viable for surgical use.

Organox Limited is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under Class III classification—reserved for high-risk devices—they require stringent premarket approval (PMA) and Unique Device Identification (UDI) compliance. This classification reflects the critical nature of preserving organs for transplantation, where failure could pose severe risks to patients.

Organox Limited’s devices are listed under the FDA’s Premarket Approval (PMA) and Unique Device Identification (UDI) programs. These registries ensure traceability and compliance tracking for high-risk Class III devices, which are essential for monitoring safety and performance in clinical settings. The PMA process verifies the device’s safety and effectiveness before market authorization, while UDI enables unambiguous identification in healthcare systems.

Organox Limited’s devices are classified as Class III because they support life-sustaining or life-supporting functions (organ preservation for transplantation) and pose a high risk if they fail. Under FDA guidelines, Class III devices require the highest level of regulatory control, including premarket approval (PMA), to ensure their safety and efficacy. This classification aligns with the critical role these systems play in extending the viability of donor organs during transport.