Core Viewpoint - The company has received a medical device registration certificate for its fully automated fluorescent immunoassay analyzer, which is expected to enhance its competitiveness and market expansion capabilities, although the impact on performance remains uncertain due to various influencing factors [1] Group 1: Product Registration - The company received the medical device registration certificate from the Guangdong Provincial Drug Administration [1] - The registration number is 粤械注准20252221513, and it is valid until November 17, 2030 [1] - The analyzer is classified as a Class II medical device [1] Group 2: Product Capabilities - The analyzer can test human serum and plasma samples [1] - It has a maximum processing capacity of 72 samples per hour [1] Group 3: Market Implications - The certification represents a breakthrough for the company in the field of multi-detection [1] - The sales performance of the product will be influenced by various factors, making the impact on financial performance unpredictable [1]
亚辉龙:取得全自动荧光免疫分析仪医疗器械注册证