3Dsystems, Simbionix Products

3Dsystems’ Simbionix brand specialises in medical simulation devices. Specifically, it produces the Procedure Rehearsal Studio, a platform designed for medical training and procedural rehearsal in clinical settings. These devices are intended to help healthcare professionals practice and refine skills in a realistic, controlled environment.

3Dsystems’ Simbionix brand is headquartered in the United States. The company’s regulatory and operational base is located there, though its devices may be distributed globally depending on market demand and compliance requirements.

Simbionix’s devices are classified as Class II medical devices under US regulations. This classification is determined by the FDA based on the level of risk associated with the device’s intended use. Class II devices generally require performance standards or special controls to ensure safety and effectiveness, and they are authorised through the FDA’s 510(k) pathway.

Simbionix’s devices are listed in the FDA’s 510(k) registry. This registry documents devices that have been authorised through the 510(k) pathway, which demonstrates compliance with FDA requirements for safety and effectiveness. The registry serves as a public resource for tracking authorised medical devices in the US.