格隆汇10月21日丨美康生物(300439.SZ)公布，近日取得了由浙江省药品监督管理局颁发的《中华人民 共和国医疗器械注册证（体外诊断试剂）》。上述《注册证》的取得，丰富了公司在体外诊断生化及化 学发光细分领域产品线的品种，有利于进一步提升公司的核心竞争力和市场拓展能力，对公司未来的经 营将产生积极影响。 | 序号 | 注册人名称 | 产品名称 | 注册证编号 | 注册证有效期间 | 预期用途 | | --- | --- | --- | --- | --- | --- | | 1 | 美康生物 | 25-羟基维生素 D 检 测试剂盒(胶乳免疫 | 浙 械 注 准 | 2025 年9月 26日至 | 用于体外定量测定人血清 中 25-羟基维生素 D 的浓 | | | | 比浊法) | 20252401757 | 2030年9月25日 | 度。 | | 2 | 美康生物 | 胆酸检测试剂盒(胶 乳免疫比浊法) | 浙 械 注 准 20252401793 | 2025年10月12日至 2030 年 10月 11日 | 用于体外定量测定人血清 中胆酸的浓度。 | | ਤੇ | 美康生物 | 胰岛素样生长因子-I 检 ...

Group 1 - Meikang Biotech has recently obtained the Medical Device Registration Certificate issued by the Zhejiang Provincial Drug Administration [1] - The registered products include the "25-Hydroxyvitamin D Test Kit" among others [1] Group 2 - The interview with He Keng emphasizes the need to shift funding focus from excessive investment in housing and infrastructure to enhancing social welfare [1]

证券代码：300439 证券简称：美康生物 公告编号：2025-057 美康生物科技股份有限公司 美康生物科技股份有限公司 关于公司取得医疗器械注册证的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 美康生物科技股份有限公司(以下简称"美康生物"或"公司")于近日取得 了由浙江省药品监督管理局颁发的《中华人民共和国医疗器械注册证（体外诊断 试剂）》（以下简称"《注册证》"），具体情况如下： | 序号 | 注册人名称 | 产品名称 | | 注册证编号 | | 注册证有效期间 | | | 预期用途 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1 | 美康生物 | 25-羟基维生素 D 测试剂盒(胶乳免疫 | 检 | 浙 械 注 准 | 年 2025 | 9 | 月 26 | 日至 | 用于体外定量测定人血清 中 25-羟基维生素 D 的浓 | | | | 比浊法） | | 20252401757 | 2030 年 | 9 月 | 25 | 日 | 度。 | | 2 | 美 ...

美康生物科技股份有限公司 证券代码：300439 证券简称：美康生物 公告编号：2025-058 近日，公司在上述使用期限及额度内使用部分闲置募集资金进行现金管理， 具体情况如下： 一、本次使用部分闲置募集资金进行现金管理的进展情况 单位：人民币万元 | 序 号 | 受托人名称 | 产品名称 | 产品类型 | | 委托理 财金额 | 起始日 | 到期日 | 预计年化收益 率 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1 | 中国银行宁波 下应支行 | 挂钩型结构 性存款 | 保 本 浮 收 益 型 | 动 理 | 2,450.00 | 2025/10/20 | 2026/1/28 | 0.59%-2.70% | | | | | 财产品 | | | | | | | 2 | 中国银行宁波 下应支行 | 挂钩型结构 性存款 | 保 本 浮 收 益 型 | 动 理 | 2,550.00 | 2025/10/21 | 2026/1/30 | 0.6%-2.62% | | | | | 财产品 | | | | | | 注：公司与上述产品受托人不存 ...

Core Viewpoint - The company anticipates pressure on domestic revenue and profits in 2025 due to the full implementation of policies such as centralized procurement, disassembly of testing packages, and standardization of charging [2] Group 1: Domestic Market Strategy - The company's self-produced revenue is primarily composed of biochemical products, with most biochemical projects included in the centralized procurement scope after three rounds of inter-provincial alliance procurement for liver function, kidney function, and glucose metabolism [2] - The company plans to enhance refined management, implement large-scale production, optimize the supply chain, and increase operational efficiency to improve market share and brand influence in the immunological products sector [2] Group 2: Growth Initiatives - The company will accelerate its overseas market expansion and aims to create new performance growth points domestically through precision diagnostic products such as mass spectrometry and precise blood lipid testing [2]

Core Viewpoint - Meikang Bio primarily engages in the research, production, and sales of in vitro diagnostic products, as well as providing third-party medical diagnostic services. The company has indicated that any future developments in brain-computer interface technology will comply with relevant laws and regulations regarding information disclosure [1] Group 1 - The company focuses on in vitro diagnostic products and related services [1] - Future developments in brain-computer interface technology will adhere to legal and regulatory requirements [1]

Core Viewpoint - Meikang Bio has developed the VAP (Vertical Auto Profile) technology for precise lipid testing, addressing the high incidence and mortality rates of atherosclerosis in China, thus filling a technological gap in the domestic market [1] Group 1: Technology Development - The VAP technology can directly measure 15 subcomponents of lipoprotein cholesterol and particle concentration levels, providing precise diagnostic indicators for the etiology of atherosclerosis [1] - The technology has officially entered the standardized clinical application phase, promoting the development of clinical lipid management towards precision [1]

Core Viewpoint - Meikang Bio has recently obtained the Medical Device Registration Certificate for in vitro diagnostic reagents issued by the Zhejiang Provincial Drug Administration [2] Group 1 - The announcement was made on the evening of September 26 [2] - The certification is significant for the company's product offerings in the medical device sector [2]

Core Viewpoint - Meikang Bio (300439.SZ) has recently obtained the Medical Device Registration Certificate for in vitro diagnostic reagents from the Zhejiang Provincial Drug Administration, which is expected to enhance the company's product line in the field of blood coagulation diagnostics and positively impact its future operations [1] Group 1 - The product name is Anti-Xa Test Kit (Colorimetric Substrate Method) [1] - The acquisition of the registration certificate enriches the company's product offerings in the in vitro diagnostic blood coagulation niche [1] - This development is anticipated to improve the company's core competitiveness and market expansion capabilities [1]

美康生物科技股份有限公司 三、备查文件 证券代码：300439 证券简称：美康生物 公告编号：2025-056 美康生物科技股份有限公司 关于公司取得医疗器械注册证的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 美康生物科技股份有限公司(以下简称"美康生物"或"公司")于近日取得 了由浙江省药品监督管理局颁发的《中华人民共和国医疗器械注册证（体外诊断 试剂）》（以下简称"《注册证》"），具体情况如下： 一、医疗器械注册证的具体情况 | 序号 | 注册人名称 | | 产品名称 | 注册证编号 | 注册证有效期间 | | 预期用途 | | --- | --- | --- | --- | --- | --- | --- | --- | | 1 | 美康生物 | 抗 Xa | 检测试剂盒（发 | 浙 械 注 准 | 2025年9月16 | 日至 | 用于体外定量测定人血浆 中普通肝素（UFH）和低分 | | | | 色底物法） | | 20252401717 | 年 月 2030 9 15 | 日 | 子量肝素（LMWH）的活性。 | 二、对公司业绩的影响及风 ...