Core Viewpoint - The company, Aihuilong, has received medical device registration certificates for two products from the Guangdong Provincial Drug Administration, enhancing its product line in the field of liver and kidney disease diagnostics [1] Group 1: Product Registration - The two registered products are the anti-gp210 IgG antibody test kit and the anti-phospholipase A2 receptor IgG antibody assay kit, both utilizing chemiluminescence technology [1] - The registration certificates are valid until November 25, 2030, and both products are classified as Class II medical devices [1] Group 2: Diagnostic Applications - The products are intended for auxiliary diagnosis of primary biliary cholangitis and idiopathic membranous nephropathy [1] Group 3: Market Impact - The company has obtained a total of 176 domestic medical device registration certificates for chemiluminescence reagents [1] - The new certifications will help enrich the fully automated chemiluminescence product line, but the sales performance of these products is subject to market conditions, making the impact on financial performance difficult to predict [1]
亚辉龙:取得两款医疗器械注册证,丰富发光产品线