普门科技获全自动化学发光免疫分析仪医疗器械注册证

Core Viewpoint - Shenzhen Pumen Technology Co., Ltd. has received a medical device registration certificate for its fully automated chemiluminescence immunoassay analyzer, enhancing its product portfolio and market competitiveness [1] Group 1: Product Registration - The product is classified as Class II medical device with a validity period until September 2, 2030 [1] - The analyzer can perform tests at speeds of 200 and 260 tests per hour, showcasing significant efficiency [1] Group 2: Market Position and Impact - The company has obtained 103 registration certificates for electrochemical luminescence testing reagents and 3 registration certificates for analyzers domestically [1] - The new certification is expected to strengthen the company's competitive edge and facilitate market expansion [1] - However, the sales of the product are influenced by market promotion efforts, making the impact on performance difficult to predict [1]