Redsense Medical announces today that the UK Medicines & Healthcare products Regulatory Agency (MHRA), the executive agency responsible for regulating the UK medical devices market, has confirmed the Company’s registration of the Redsense system.

Following the United Kingdom’s withdrawal from the European Union, all medical devices placed on the Great Britain market need to be registered with the MHRA. The CE marking continues to be recognized until 30 June 2023, but devices must complete registration with the MHRA during a certain period of grace to be legally maintained on the UK market. With the confirmation of registration announced today, Redsense complies with the new requirements.

"The timely registration with the MHRA ensures our continued access to the vital UK market, and we welcome the smooth transition. This means that we are good to go,"says Patrik Byhmer, CEO of Redsense Medical AB. 

For more information, please contact:

Patrik Byhmer, CEO Redsense Medical AB (publ)

Phone: +46 35 10 60 30

info@redsensemedical.com 

www.redsensemedical.com

ABOUT REDSENSE MEDICAL

Redsense Medical is a corporate group with operations mainly in Europe and the United States. The company has developed the Redsense System, an innovationused for monitoring and alarm in the case of blood leakage in connection with a hemodialysis treatment. Redsense Medical solves one of the most serious remaining safety problems within hemodialysis – to quickly detect Venous Needle Dislodgement and catheter leakage to minimize blood leakage. The system consists of a patented fiber optic sensor, designed for either venous needle or central venous catheter, which is connected to an alarm unit. From the very start, the development of the company's technology has been based on the demands and safety requirements of healthcare providers in the dialysis sector.