透景生命：取得医疗器械注册证及申报医疗器械注册获得受理

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, focusing on infection detection products related to hepatitis B virus and respiratory infections, which will enhance the company's product matrix but will not impact recent performance [1] Group 1 - The company has obtained one medical device registration certificate and had eight applications accepted, which are primarily in the infection detection field [1] - The accepted products are related to hepatitis B virus and respiratory infections, which will enrich the company's product offerings [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 - The 2024 edition of the Chinese Medical Association's guidelines for lung cancer indicates that serological tests can aid in assessing treatment efficacy and monitoring [1] - The acquisition of the medical device registration certificate will enhance the company's flow cytometry product line, better meeting clinical diagnostic needs for lung cancer detection [1] - This development is expected to strengthen the company's competitiveness in the in vitro diagnostic field and improve market expansion capabilities, although the actual sales impact remains uncertain [1]