FDA Clears UV Smart’s D60 TEE Probe Disinfection System

UV Smart has earned U.S. Food and Drug Administration (FDA) 510(k) clearance of its D60 UV-C disinfection device, for sterilizing TEE probes. The company claims the D60 is the world’s first UV-C high-level disinfection product to receive FDA clearance for this application.

An innovative idea between two friends has quickly grown into an international organization that is now active in 35 countries and reportedly is the market leader in its segment.

From Hours to Minutes

The FDA clearance applies to the UV Smart D60, system that disinfects medical TEE probes—sensitive medical instruments for heart examination used in cardiology—with UV-C light. Current cleaning and disinfection with harsh chemicals can often take approximately two hours, but the D60 achieves high-level disinfection in just two minutes using UV-C light. For healthcare providers, the D60 represents a significant improvement in efficiency and workflow, according to UV Smart.

“This clearance will help fulfill the need in U.S. healthcare for validated options that reduce manual workload, improve safety, and support more efficient clinical workflows,” UV Smart Co-Founder Thijs Kea said.

UV Smart is redefining hospital efficiency, seamlessly scaling facility capacity while fortifying safety for healthcare workers. Its equipment enables faster disinfection cycles, allowing more patients to be treated per day. In addition, the system eliminates the cost of chemicals and reduces wear and tear on costly cardiology equipment.

With its entry into to the United States, UV Smart is entering the next phase of its international growth strategy. UV Smart is demonstrating that chemical-free high-level disinfection can support both operational efficiency and long-term cost control in healthcare settings.

UV Smart Technologies B.V. is a Dutch medtech company developing UV-C high-level disinfection products. Since its founding in 2017 by Daan Hoek and Thijs Kea, the company has grown into an international player with approximately 30 employees in the Netherlands, Germany, and the United Kingdom. The portfolio, consisting of the D25, D45 and D60, is specifically aimed at disinfecting cardiology, gynecology, TEE, and ENT equipment respectively. UV Smart supplies hospitals and clinics in 35 countries.