TUBYCON’s all-in-one urine specimen cup ‘TUBYCON-U’ has been registered as a medical device with the U.S. Food and Drug Administration (FDA) through Establishment Registration & Device Listing. With this registration, TUBYCON has secured the institutional foundation needed to supply its products to the U.S. market.
The all-in-one urine cup is designed so that everything from specimen collection to tube separation takes place within a single container, reducing the risk of infection exposure and specimen mix-ups during testing. The U.S. FDA registration marks a starting point that shows the product’s safety and quality management system meet global regulatory requirements, laying the groundwork for expansion into North America and other overseas markets.
Building on this FDA registration, TUBYCON is pursuing certifications in key markets, including the EU CE IVDR and Australia’s TGA, as it works to provide safe and precise specimen-collection solutions to healthcare settings around the world.
