BIOCOMPATIBLES UK LTD

Biocompatibles UK Ltd specializes in devices primarily used in oncology and interventional radiology. Their portfolio includes radioactive glass microspheres (such as Yttrium-90 TheraSphere) for permanent internal brachytherapy, which are implanted to treat liver cancer. They also produce non-bioabsorbable embolization particles for blocking blood flow in vessels and kits for manual-afterloading brachytherapy, which assist in delivering radiation sources during procedures. Additionally, they manufacture medication transfer sets to administer these therapies safely.

Biocompatibles UK Ltd is based in the United States, meaning their devices fall under FDA regulatory jurisdiction. The company’s products are listed in the FDA’s 510(k) and Unique Device Identification (UDI) databases, indicating they undergo premarket review and compliance tracking as required by US regulations. This ensures their devices meet applicable safety and performance standards before commercial distribution.

Biocompatibles UK Ltd’s devices are documented in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system. These registries track Class II and Class III devices, which require regulatory submissions to demonstrate compliance with US safety and effectiveness requirements. The UDI system also enables traceability of individual devices in clinical and commercial settings.

Biocompatibles UK Ltd’s devices are classified as Class II and Class III under the FDA’s regulatory framework. Class III devices, such as their Yttrium-90 TheraSphere microspheres, are typically those supporting or sustaining human life, presenting a potential unreasonable risk of illness or injury if they fail. These require premarket approval (PMA) or premarket notification (510(k)) with special controls to ensure rigorous safety validation. Class II devices may involve moderate risk and require 510(k) clearance with performance standards or postmarket surveillance.