Umana Medical Technologies Ltd

Umana Medical Technologies Ltd specialises in wearable medical devices designed for continuous monitoring and telemetry. Their portfolio includes sensors like the T1 SmarterSkin Plus and T1 SmarterSkin, which are intended for long-term skin contact monitoring, as well as the Umana T1 Heart Monitor, a cardiac telemetry device. These products focus on collecting and transmitting vital signs data for remote patient observation, particularly in cardiology, diabetes management, and telemedicine settings.

Umana Medical Technologies Ltd is headquartered in Malta. While the company’s primary operations are based in Malta, it operates across a broad global network, including territories in Europe, Asia, Australia, Africa, the Middle East, Latin America, and the USA. This international presence allows them to serve diverse markets with their monitoring solutions.

Yes, Umana Medical Technologies Ltd’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. Listing in eudamed is required under EU Medical Device Regulations (MDR) to ensure transparency and traceability of devices marketed within the EU. This registry helps healthcare professionals and regulators verify the manufacturer and device details.

Under the EU Medical Device Regulations (MDR), Umana Medical Technologies Ltd’s devices are classified as Class I and Class IIa. Classification determines the regulatory requirements for device safety, performance, and post-market surveillance. Class I devices generally pose minimal risk and require basic compliance measures, while Class IIa devices involve slightly higher scrutiny due to moderate risk, such as those used for monitoring vital signs like heart rate or skin contact data.