Core Insights - Guangzhou Wondfo Biotech Co., Ltd. has received approval from the National Medical Products Administration and the Guangdong Provincial Medical Products Administration for nine self-developed test kits [1] - The newly approved thrombus five-item test and tumor marker test kits will provide a richer testing menu and more convenient combinations for clinical use [1] Group 1: Product Development - The thrombus five-item test, including D-Dimer, aids in the auxiliary diagnosis of thrombotic diseases, early diagnosis of DIC, monitoring of thrombolytic and anticoagulant drug efficacy, and diagnosis of vascular endothelial system damage [1] - Wondfo Biotech has launched multiple fully automated chemiluminescence immunoassay analyzers with varying throughput, catering to different application scenarios [1] Group 2: Market Position and Future Plans - The company has obtained over 150 medical device product registrations globally, covering nine major areas including cardiac markers, inflammation, thrombosis, thyroid, sex hormones, anemia, bone metabolism, tumors, and infectious disease testing [1] - Wondfo Biotech aims to continue leveraging its high-level, global R&D innovation system, focusing on technological, product, and service innovations to benefit the public [1]

Core Viewpoint - Wanfu Biology's subsidiary, Tianshen Medical, has received approval for nine self-developed test kits from the National Medical Products Administration and Guangdong Provincial Drug Administration, enhancing clinical testing options [1] Group 1: Product Development - The approved test kits include thrombosis five-item tests and tumor marker tests, providing a richer testing menu and more convenient combinations for clinical use [1] - By July 2025, Wanfu Biology's single-use chemiluminescence system is expected to have obtained 16 medical device registration certificates for tumor marker detection, making it the most comprehensive small-scale luminescence system in China [1] Group 2: Market Position - Wanfu Biology's single-use chemiluminescence product line has received over 150 medical device registration certificates globally, covering nine major testing areas including cardiac markers, inflammation, thrombosis, thyroid, sex hormones, anemia, bone metabolism, tumors, and infectious diseases [1]

Group 1 - The company Wanfu Bio announced that its wholly-owned subsidiary Shenzhen Tianshen Medical Device Co., Ltd. has received 9 medical device registration certificates from the National Medical Products Administration and Guangdong Provincial Medical Products Administration [1] - The registered products include thrombosis detection reagents and tumor marker detection reagents [1]

Group 1 - The core point of the article is that Wanfu Biological (300482) announced that its wholly-owned subsidiary, Shenzhen Tianshen Medical Equipment Co., Ltd., has received medical device registration certificates from the National Medical Products Administration and the Guangdong Provincial Drug Administration for various testing reagents, including thrombosis five-item testing reagents and tumor marker testing reagents [2][3] Group 2 - The medical device registration certificates signify regulatory approval for the company's new products, which may enhance its market position in the medical testing industry [2] - The approval of these testing reagents could potentially lead to increased revenue streams for the company as it expands its product offerings [2] - This development reflects the company's ongoing commitment to innovation and compliance with regulatory standards in the healthcare sector [2]