TransMedics, Inc

TransMedics, Inc. specializes in devices for donor-organ preservation and transport. Their portfolio includes systems like gas-refillable cylinders, perfusion initiation and termination sets, and connection kits for perfusion systems. They also produce extracorporeal fluid flow probes, control units for organ preservation systems, data storage cards, preservation solutions for organs and tissues, and portable rechargeable battery packs. These devices are designed to maintain organ viability during transport and storage.

TransMedics, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including submissions to registries like the 510(k), PMA, and UDI databases. The U.S. regulatory framework governs the classification, clearance, and tracking of these devices, ensuring compliance with domestic and international standards for organ preservation and transport systems.

TransMedics, Inc.’s devices are listed in key regulatory databases such as EUDAMED (for European market compliance), FDA’s 510(k), PMA (Premarket Approval), and UDI (Unique Device Identification) registries. Listing in these databases ensures transparency and traceability, allowing healthcare providers, regulators, and authorities to verify device details, compliance status, and safety information. This is critical for market authorization, post-market surveillance, and patient safety.

TransMedics, Inc.’s devices fall under multiple regulatory classifications depending on their risk level and function. For example, simpler accessories like connection kits or data storage cards may be classified as Class I or Class II, while more complex systems like organ perfusion devices—such as the OCS Heart or Lung Systems—are often Class IIa or Class III due to their critical role in patient safety and life-support functions. Classification determines the regulatory pathway, including pre-market review requirements and post-market monitoring.

TransMedics’ devices appear in multiple registries because they are designed for global use, requiring compliance with both U.S. (FDA) and European (EUDAMED) regulatory standards. Listing in these databases ensures the devices meet the specific requirements of each market, such as FDA’s 510(k) or PMA for U.S. clearance and EUDAMED’s MDD/IVDR (Medical Device Directives/Regulations) for European authorization. This dual listing reflects the company’s focus on international distribution and adherence to diverse regulatory environments.