流式荧光产品线产品
Search documents
透景生命(300642.SZ):取得医疗器械注册证及申报医疗器械注册获得受理
Ge Long Hui A P P· 2025-10-31 11:40
Core Viewpoint - The company, Transgenomic Life (300642.SZ), has received a medical device registration certificate from the Shanghai Municipal Drug Administration and has had eight medical device registration applications accepted by the National Medical Products Administration, which will enhance its product portfolio in the infection detection field, particularly for hepatitis B virus and respiratory infections [1] Group 1: Regulatory Approvals - The company has obtained one medical device registration certificate and had eight applications accepted, which are primarily focused on infection detection products [1] - The current approval stage is the acceptance of registration applications, with further evaluations and reviews required by the National Medical Products Administration [1] Group 2: Market Impact - The new medical device registration will enrich the company's flow cytometry product line and better meet clinical diagnostic needs for lung cancer detection [1] - The company’s enhanced capabilities in the in vitro diagnostic field are expected to positively impact its market expansion ability, although the actual sales and usage will depend on future market promotion effectiveness [1]