UV Smart Announces FDA 510(k) Clearance for D60 TEE Probe Disinfection System

RIJSWIJK, Netherlands--(BUSINESS WIRE)--The Netherlands-based MedTech company UV Smart has officially received clearance from the United States Food and Drug Administration (FDA). With this 510(k) clearance, UV Smart is launching its groundbreaking UV-C technology for the high-level disinfection of TEE probes in the United States: The D60 is the first UV-C high-level disinfection device in the world to receive FDA clearance for this application.

What started as an innovative idea between two friends, has quickly grown into an international organization that is now active in 35 countries and is the market leader in its segment. With the support of investor Chris Oomen (founder of Optiver), UV Smart proves that Dutch innovation can make healthcare better and affordable worldwide.

From hours to minutes

The FDA clearance applies to the UV Smart D60: A system that disinfects medical TEE probes, sensitive medical instruments for heart examination used in cardiology, with UV-C light. Where current cleaning & disinfection with harsh chemicals can often take approximately two hours, 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; the D60 is the first device of its kind to receive FDA 510(K) clearance for high-level disinfection of TEE probes.

“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,” says co-founder Thijs Kea.

Efficiency as a revenue model

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 & 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.

About UV Smart

UV Smart Technologies B.V. is a Dutch MedTech company that makes healthcare safer and more affordable with innovative 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 thirty employees in the Netherlands, Germany and the United Kingdom.

The portfolio, consisting of the D25, D45 and D60, is specifically aimed at the disinfection of cardiology, gynecology, TEE and ENT equipment respectively. UV Smart now supplies hospitals and clinics in 35 countries. With the forthcoming expansion to the United States, the company is aiming for strong global growth.

Images: More images of the D60 and its founders are available on request.

About the 510(k) approval: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251354