Asieris(SH:688176) Ge Long Hui A P P·2025-12-21 07:56Core Viewpoint - The company, Yahui Pharmaceutical (688176.SH), has submitted a medical device registration application for its product APLD-2304 to the EU Notified Body (BSI Group The Netherlands B.V.), which has been accepted. The product aims to enhance bladder cancer diagnosis and monitoring, but this submission will not have a significant impact on the company's recent performance [1]. Group 1 - APLD-2304 is the world's first portable single-use blue light cystoscope developed for bladder cancer diagnosis and follow-up monitoring [1]. - The product addresses the limitations of traditional white light cystoscopy, which often overlooks early-stage bladder cancer due to its flat growth or small margins, leading to low detection rates and high recurrence rates [1]. - The combination of APLD-2304 with blue light imaging agents forms a diagnostic solution that improves bladder cancer detection rates and reduces recurrence rates, while its design enhances convenience for doctors and comfort for patients, minimizing the risk of cross-infection [1].