| 证券代码：603658 证券简称：安图生物 公告编号：2025-057 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 郑州安图生物工程股份有限公司 | | | | | | | | | 关于获得医疗器械注册证的公告 | | | | | | | | | 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 | | | | | | | | | 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 | | | | | | | | | 郑州安图生物工程股份有限公司（以下简称"公司"或"安图生物"）于近 | | | | | | | | | 日收到河南省药品监督管理局颁发的医疗器械注册证，具体如下： | | | | | | | | | 一、医疗器械注册证的具体情况 | | | | | | | | | 注册证 | | | | | | | | | 产品名称 注册证编号 预期用途 | 编号 | | | | | | | | 有效期 | | | | | | | | | IgE 总 检测试剂盒（磁微 本产品用于定量检测 ...

万孚生物(300482)7月20日晚间公告，公司近日收到国家药监局颁发的人类微卫星不稳定性（MSI）检测 试剂盒（荧光PCR熔解曲线法）的医疗器械注册证。MSI检测对多种实体瘤患者有重要意义，包括林奇 综合征筛查、指５-FU类化疗药物的选择、预后分层和筛选免疫检查点抑制剂获益人群等。 ...

Group 1: Drug Procurement and Regulations - The National Healthcare Security Administration has initiated the 11th batch of national drug centralized procurement, with 55 varieties included in the reporting range [1] - The procurement rules emphasize principles such as "stabilizing clinical use, ensuring quality, preventing collusion, and avoiding internal competition" [1] - Only mature "old drugs" that have been on the market for years and have expired patent protection will be included, while innovative drugs will not be part of this procurement [1] Group 2: Company Announcements and Developments - Xinhua Pharmaceutical's subsidiary received a Class III medical device registration certificate for a sterile saline solution for contact lens care [3] - Sanyou Medical announced that its spinal internal fixation connector system, JAZZSystem, received approval for market launch [4] - China National Pharmaceutical Group fully acquired Lixin Pharmaceutical for a consideration of up to $950.92 million [10] Group 3: Financial Performance - Baicheng Pharmaceutical expects a net profit of 0 to 6 million yuan for the first half of 2025, a decline of 95.53% to 100% year-on-year [6] - Kanglong Chemical anticipates a net profit of 67.92 million to 71.26 million yuan for the first half of 2025, a decrease of 36% to 39% year-on-year, despite a growth in core business [7] Group 4: Clinical Trials and Research - AstraZeneca's Baxdrostat achieved significant results in a Phase III clinical trial for patients with uncontrolled or resistant hypertension [13] - Hengrui Medicine reported positive results from a Phase III clinical trial of its GLP-1/GIP dual receptor agonist, HRS9531, showing a maximum weight reduction of 19.2% [14]

Core Viewpoint - Shanghai United Imaging Healthcare Co., Ltd. has announced the acquisition of medical device registration certificates in both domestic and major overseas markets, reflecting its strong market access capabilities and product competitiveness [1][2]. Group 1: Medical Device Registration - The company has obtained various medical device registration certificates, including a medical angiography X-ray machine and multiple MRI systems, with effective dates ranging from January 2025 to June 2025 [1]. - The company has achieved global registration coverage in over 80 countries and regions, with more than 140 products approved for market, including 51 products with FDA 510(k) certification and 52 products with EU CE marking [1]. Group 2: Product Development and Market Strategy - The company has developed products tailored to the specific needs of different countries and regions, enhancing its core competitiveness and expanding the types of products available for sale abroad [2]. - The successful registration of these medical devices is expected to enrich the company's product offerings and meet diverse clinical demands, although the actual sales impact remains uncertain [2]. Group 3: Key Product Achievements - The company has made significant breakthroughs in interventional imaging equipment, with its self-developed digital subtraction angiography system (DSA) uAngio AVIVA CX receiving FDA 510(k) certification, marking it as the first and only domestic DSA device approved for the U.S. market [1]. - The company plans to complete the EU CE certification process for this product by the third quarter of 2025, aiming to provide advanced solutions in the global interventional medicine field [1].

达安基因（002030）公告，公司近日取得国家药品监督管理局颁发的医疗器械注册证一个。该产品为六 项呼吸道病原体核酸检测试剂盒(PCR-荧光探针法)，有效期自批准之日起至2030年6月5日。该产品用于 定性检测人口咽拭子中6项呼吸道病原体核酸，包括呼吸道合胞病毒、人博卡病毒、腺病毒、鼻病毒、 肺炎衣原体和肺炎支原体。上述医疗器械注册证的取得丰富了公司的产品组合，拓宽了公司产品的应用 领域。 ...

Group 1 - The company, Kangtai Medical (300869), has recently obtained a medical device registration certificate from the Hebei Provincial Drug Administration for a disposable anesthesia laryngoscope [1] - The product is designed to assist in exposing the epiglottis to guide medical personnel in accurately performing airway intubation for anesthesia or emergency use [1] - The registered product models include G2, G3, G4, C2, C3, and C4, with the registration certificate number being冀械注准20252080126 [1] Group 2 - The approval date for the medical device is May 6, 2025, and it will be effective from the same date, remaining valid until May 5, 2030 [1] - The product can also be utilized for oral examinations and treatments [1]

Group 1 - The company, Opcon Vision (300595), has received a medical device registration certificate from the National Medical Products Administration for its new product, "Orthokeratology Rigid Gas Permeable Contact Lens" [1] - The product is designed for temporary correction of myopia for users with myopia degrees between -0.50D and -4.00D and astigmatism degrees within 1.50D [1] - The product is non-sterile and requires cleaning and disinfection before use, with a recommended replacement cycle of one year and a shelf life of five years [1]