普门科技(688389.SH)取得一项医疗器械注册证

Core Viewpoint - The company has received a medical device registration certificate from the Guangdong Provincial Drug Administration for its new fully automated chemiluminescence immunoassay analyzers, the eCL8600 and eCL8800 series, which utilize a novel electrochemical luminescence immunoassay technology [1] Group 1 - The newly registered analyzers have testing speeds of 200 tests per hour for the eCL8600 series and 260 tests per hour for the eCL8800 series, enhancing testing efficiency [1] - The devices support batch testing with intelligent scheduling and prioritize specified sample tubes for testing, providing results in as fast as 9 minutes [1] - The analyzers allow for continuous operation with non-stop consumable replacement, ensuring uninterrupted testing processes [1] - The use of biomimetic mixing technology improves mixing efficiency, contributing to better testing convenience and efficiency for end hospitals [1]