Jafron Biomedical’s Blood Purification Devices Gain EU Market Approval Under MDR

Jafron Biomedical Co., Ltd, a prominent player in the blood purification sector based in China, has announced that its Category III medical devices, the cytokine adsorption column and the disposable blood perfusion device, have secured market approvals within the European Union. This approval is in accordance with the stringent Medical Devices Regulation (EU) 2017/745 (MDR), signifying a significant step forward for the company’s global expansion.

The cytokine adsorption column is designed to neutralize inflammatory mediators, including cytokines and P2Y12 inhibitors like ticagrelor, as well as Xa factor inhibitors such as rivaroxaban, bilirubin, and myoglobin through extracorporeal therapy. This innovative device plays a crucial role in mitigating the progression of patient conditions by reducing the impact of these inflammatory markers.

Additionally, the disposable blood perfusion device is engineered for extracorporeal blood circulation, targeting the removal of large molecule toxins like β2-microglobulin (β2-MG) and protein-bound toxins such as indophenol sulfate (IS) in patients with end-stage renal disease. This device is instrumental in alleviating the disease’s progression, which is often exacerbated by the accumulation of harmful substances that traditional dialysis may not effectively remove.- Flcube.com

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