性激素类质控品
Search documents
普门科技取得两个医疗器械注册证
Zhi Tong Cai Jing· 2025-12-16 10:24
Core Viewpoint - The company, Pumen Technology (688389.SH), has recently received two medical device registration certificates from the Guangdong Provincial Drug Administration for in vitro diagnostic reagents, indicating a significant advancement in its product offerings [1] Group 1: Product Registration - The registered products are composite quality control products, specifically for sex hormone quality control and thyroid function quality control [1] - These products utilize sample measurement procedures to assess quality control items, ensuring the safety and effectiveness of the company's electrochemical luminescence detection system [1]
普门科技(688389.SH)取得两个医疗器械注册证
智通财经网· 2025-12-16 10:17
Core Viewpoint - Pumen Technology (688389.SH) has recently received two medical device registration certificates from the Guangdong Provincial Drug Administration for in vitro diagnostic reagents, indicating a significant regulatory approval for its products [1] Group 1: Product Registration - The company obtained registration certificates for two products: hormone quality control products and thyroid function quality control products [1] - Both registered products are composite quality control products, which are measured using sample measurement procedures [1] Group 2: Quality Assurance - The measurement results of the quality control products will undergo statistical analysis or comparison with reference values to determine if they meet the required standards [1] - This process ensures the safety and effectiveness of the company's electrochemical luminescence detection system [1]
普门科技:取得性激素类质控品、甲状腺功能质控品医疗器械注册证
Xin Lang Cai Jing· 2025-12-16 10:09
Core Viewpoint - The company has received two medical device registration certificates from the Guangdong Provincial Drug Administration for in vitro diagnostic reagents, indicating a significant regulatory achievement in expanding its product offerings [1] Group 1: Regulatory Achievements - The company obtained two registration certificates for quality control products related to sex hormones and thyroid function, with registration numbers 20252401568 and 20252401569, valid until November 27, 2030 [1] - As of the announcement date, the company and its subsidiaries have secured a total of 105 registration certificates for electrochemical luminescence detection reagents [1]