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贝康医疗-B(2170.HK)精子质量分析仪获江苏药监局颁发医疗器械注册证

Beacon Medical-B (2170.HK) sperm quality analyzer obtained the medical instruments registration certificate issued by Jiangsu Drug Administration.

Gelonghui Finance ·  Nov 1 17:42

On November 1st, Gelonghui | Beckon Medical-B (2170.HK) announced that the sperm quality analyzer (BKA210) developed by the company obtained the medical device registration certificate (registration number: Su Xie Zhun 2024222101) issued by the Jiangsu Provincial Pharmaceutical Supervision and Administration Bureau on November 1, 2024. BKA210 is the world's first device developed independently based on the "WHO Laboratory Manual for the Examination and Processing of Human Semen (Sixth Edition)" capable of detecting unstained live sperm. This instrument won the Excellent Project Award in the 2021 National Disruptive Technology Innovation Competition, and has the following advantages: 1. High-precision analysis: BKA210, trained with 0.5 million clinical data, can instantly analyze the concentration, vitality, and morphology of unstained live sperm, with accuracy rates of 98.30%, 97.69%, and 93.29% respectively. 2. High-definition dynamic transmission: The instrument can transmit real-time high-definition images, avoiding the influence on sperm morphology during staining, enabling multi-angle analysis, and performing static and dynamic artificial intelligence analysis of unstained sperm. 3. Fast and simple: BKA210 can complete the analysis of sperm morphology, concentration, and vitality in as fast as 3 minutes, simplifying the diagnosis and treatment process, enhancing patient satisfaction, and marking the entry of clinical semen testing into a new era of intelligence. The launch of this device will bring higher efficiency and accuracy to semen testing.

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