Class Medical is dedicated to improving patient safety. Our flagship product, the TUCSV, is designed to prevent the serious and recurring problem of urethral catheter balloon injury during the insertion of an indwelling catheter.
Our strategy is focused on global expansion through a network of established distribution partners. Key company objectives include securing FDA 510(k) clearance to enter the U.S. market, expanding our commercial footprint in existing territories, and optimising our manufacturing process to reduce costs and drive profitability. We are positioned for significant growth as we pursue our vision of a world without catheter balloon injuries.
Class Medical serves a growing number of international markets through exclusive distribution partnerships, including Ireland, the United Kingdom, Europe, Australia, Canada, and the United Arab Emirates. Additionally, we are actively preparing for entry into the United States, our largest target market, with an anticipated FDA 510(k) clearance in the first half of 2026.
