SUBSTRATE HD

Substrate HD develops and supplies cardiac mapping systems, including both hardware and software solutions for electroanatomical mapping in cardiac procedures. Their portfolio includes systems for real-time visualization of cardiac electrical activity, such as the VX1 platform and its associated applications, as well as specialized tools like the Volta AF-Xplorer series for atrial fibrillation mapping. Additional offerings include the DSUB and OCTOPUS systems, designed for precise intracardiac navigation and data acquisition during electrophysiological studies.

The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, and Class IIa, with corresponding listings in the EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. Their products are also subject to regulatory compliance under French and European Union medical device directives. Substrate HD operates as a manufacturer based in France.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.