普门科技：13项电化学发光试剂产品获IVDR CE认证

Core Viewpoint - The company has received IVDR CE certification from T V South German Group for 13 electrochemical luminescence reagent products, enhancing its competitiveness in the EU market [1] Group 1: Certification Details - The certified products include assays for anti-thyroglobulin antibody, C-peptide, total triiodothyronine, total thyroxine, thyroxine-binding globulin, free triiodothyronine, free thyroxine, estradiol, follicle-stimulating hormone, luteinizing hormone, prolactin, and testosterone [1] - These products are classified as Class B and have a validity period until June 23, 2029 [1] - The company has a total of 20 electrochemical luminescence reagent products that have obtained IVDR CE certification to date [1] Group 2: Market Impact - The new IVDR regulations replace the previous IVDD directive, governing in vitro diagnostic medical devices in the EU market [1] - The certification allows the company’s products to enter the EU market, which is expected to positively impact the company's future operations [1]