Recognized for Infection Prevention and Sample Integrity Technology… Official Announcement by KATS Completed, Global Certifications Accelerating
TUBYCON (CEO Jay Park), a medical device specialist company, announced that it has obtained the “NEP (New Excellent Product) Certification” issued by the Ministry of Trade, Industry and Energy for its innovative “All-in-One Urine Collection Cup with Detachable Tube.” The product has been officially announced by the Korean Agency for Technology and Standards (KATS), and it has already completed FDA registration in the United States and is in the final stage of obtaining CE IVDR certification in Europe.
TUBYCON’s all-in-one urine cup integrates the cup and tube into a single unit, with a detachable tube that can be separated easily after urine collection. This structure minimizes the risks of infection, sample mix-ups, and inefficiencies in manual handling. It is also compatible with pneumatic tube systems (Air Shooters) used in hospitals. With the NEP certification, the product is now qualified for entry into the public procurement market, and its technological reliability has been officially recognized.
The follow-up product, “Dual Urine Cup TUBYCON-U2,” is designed with two attached tubes, allowing simultaneous collection of two samples from a single cup. This enables efficient multi-sample collection in health check-up centers, emergency rooms, and clinical laboratories.
CEO Jay Park stated, “It is deeply meaningful that our field-oriented technology for preventing sample errors and infections has been recognized by both the government and the market,” and added, “We will continue developing products that benefit both medical professionals and patients.”
Founded in 2022, TUBYCON is a specialized medical device company developing all-in-one specimen collection solutions that enhance infection prevention and sample reliability, as well as AI-based laboratory automation systems. The company’s products have been adopted by hospitals in Korea and abroad, and with the NEP certification, it is further strengthening its foundation of global certifications, including FDA and CE.