MediBeacon has received the CE Mark certification under the European Union (EU) Medical Device Regulation (MDR) for its transdermal glomerular filtration rate (TGFR) monitor and reusable sensor.

The two Class IIa devices, alongside the Lumitrace (relmapirazin) injection and TGFR disposable ring, form the TGFR system.

The certification confirms compliance with EU MDR 2017/745 safety, quality, and performance standards.