Recently, Beijing Lepu Medical Technology Co., Ltd attained EU Quality Management System Certificate (IVDR) issued by BSI (Notified Body Number 2797). In addition, the company's procalcitonin test kits (Fluorescence immunochromatography) obtained IVDR CE certificate, marking the first Chinese PCT product that has gained IVDR CE qualification.
The product can be a quantitative method to determine the procalcitonin in whole blood, serum and plasma in vitro, and can be used for the auxiliary diagnosis of bacterial sepsis, assisted by Lepu Quant-fluo 800 Immunofluorescence Quantitative Analyzer.
CE certification has been working as a "visa" for products to enter the EU market. The newly launched IVDR EU 2017/746 was upgraded from the previous IVDD 98/79/EC, aiming to establish a modern and stricter regulatory framework to better serve the safety of the public and the patients. Lepu Medical's acquisition of the CE certificate demonstrates the quality of the products can meet the requirements of relevant EU regulations consistently, laying a robust foundation for the product to address global medical needs.