Therakos Development Limited gains EU MDR certification for its CELLEX Photopheresis System, reinforcing its market position in bedside immunomodulatory therapy.
The certification of the THERAKOS CELLEX Photopheresis System under the EU Medical Device Regulation (MDR) marks a significant regulatory milestone that ensures continued access to the European market. By meeting these stringent safety and performance standards, the company solidifies its leadership in extracorporeal photopheresis and enhances its ability to provide bedside immunomodulatory therapy to patients across the EU.
It confirms that the CELLEX Photopheresis System meets the updated, rigorous safety and performance requirements mandated by the European Union for medical devices.
The system is designed for extracorporeal photopheresis, a bedside immunomodulatory therapy.
Therakos Development Limited has received official EU Medical Device Regulation (MDR) certification for its CELLEX Photopheresis System. This regulatory milestone validates the safety and performance of the company's bedside immunomodulatory therapy platform, facilitating continued market access across the European Union.
The certification confirms that the CELLEX Photopheresis System meets the rigorous safety and performance standards required by the European Union's updated Medical Device Regulation.