RIMED LTD.

Rimed Ltd. specializes in two primary categories of medical devices: hand-held extracorporeal ultrasound imaging transducers, such as the PW 2MHz and CW 4MHz/8MHz ultrasonic probes, and general-purpose ultrasound imaging systems like the Digi-Lite IP, Digi-One, and Digi-Lite series. These devices are designed for diagnostic imaging and Doppler studies, including transcranial Doppler devices like the INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE and its portable variants.

Rimed Ltd. is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). Since these devices are classified as Class II, they are subject to FDA regulations requiring pre-market clearance via the 510(k) pathway or other applicable pathways, as well as compliance with Unique Device Identification (UDI) requirements.

Rimed Ltd.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) registry documents pre-market clearance submissions for Class II devices, ensuring they meet FDA standards for safety and effectiveness before entering the market. The UDI registry assigns unique identifiers to devices, improving tracking, traceability, and post-market surveillance to enhance patient safety and regulatory compliance.

Rimed Ltd.’s devices are classified as Class II under FDA regulations, which means they pose moderate risk and require special controls to ensure their safety and performance. This classification typically involves pre-market notification (510(k)) submissions to demonstrate substantial equivalence to a predicate device already on the market. While Class II devices are not subject to the stringent pre-market approval process required for Class III devices, they still require compliance with FDA guidelines, labeling requirements, and post-market surveillance to maintain authorization.