MEDICALSYSTEM(300439)

Search documents
美康生物(300439) - 关于公司及控股子公司取得医疗器械注册证的公告
2025-07-25 09:15
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:2025-042 美康生物科技股份有限公司 关于公司及控股子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。 近日,美康生物科技股份有限公司(以下简称"美康生物"或"公司")及 控股子公司江西美康盛德生物科技有限公司(以下简称"江西美康")分别取得 了由浙江省药品监督管理局和江西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 | 茶碱质控品 | 浙械注准 | 2025 年 7 月 15 日至 | 与本公司生产的茶碱检测试剂 | | | | | | | 盒(质谱法)配套使用,用于人 | | | | | 20252401505 | 2030 年 7 月 14 日 | 血清或血浆中茶碱定量测定时 | | ...
美康生物:公司及控股子公司取得多项医疗器械注册证
news flash· 2025-07-25 09:10
美康生物:公司及控股子公司取得多项医疗器械注册证 智通财经7月25日电,美康生物(300439.SZ)公告称,公司及控股子公司江西美康近日取得由浙江省药品 监督管理局和江西省药品监督管理局颁发的多项《中华人民共和国医疗器械注册证(体外诊断试 剂)》。这些注册证涉及的产品包括茶碱质控品、苯妥英质控品、血管紧张素Ⅱ和Ⅰ检测试剂盒、白介 素-1β、2和2受体检测试剂盒等。这些注册证的取得将丰富公司在体外诊断化学发光及质谱细分领域产 品线的品种,有利于提升公司核心竞争力和市场拓展能力,但实际销售情况取决于未来市场推广效果, 公司目前无法预测其对未来业绩的影响。 ...
7月4日体外诊断上涨0.24%,板块个股热景生物、塞力医疗涨幅居前
Sou Hu Cai Jing· 2025-07-04 09:36
Core Viewpoint - The in vitro diagnostics sector experienced a slight increase of 0.24% on July 4, with a net outflow of funds amounting to 42.33 million [1] Group 1: Market Performance - A total of 18 stocks in the sector saw gains, while 49 stocks declined [1] - The top decliners included Dongfang Ocean (-6.51%), Xilong Scientific (-3.81%), and Nearshore Protein (-2.54%) [1][1] Group 2: Stock Performance - Notable gainers included: - Hotgen Biotech with a price of 194.81 and an increase of 20.08%, attracting a net fund inflow of 2.125 million [1] - Saily Medical at 21.08, up 10.02%, with a net inflow of 1.758 million [1] - Zhongyuan Union at 25.87, rising 9.99%, with a net inflow of 1.38 billion [1] - Decliners included: - Botao Biotech at 37.34, down 3.38%, with a net outflow of 1.087 million [1] - Maike Biotech at 7.99, down 2.44%, with a net inflow of 176.92 thousand [1]
美康生物(300439) - 2024年年度权益分派实施公告
2025-06-16 10:53
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:2025-041 美康生物科技股份有限公司 2024 年年度权益分派实施公告 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 "公司")2024 年年度权益分派方案 已获 2025 年 5 月 23 日召开的 2024 年年度股东大会审议通过,现将权益分派事 宜公告如下: 一、股东大会审议通过权益分派方案的情况 1、公司于 2025 年 5 月 23 日召开了 2024 年年度股东大会,审议通过了《关 于公司 2024 年度利润分配预案的议案》,同意公司 2024 年年度权益分派方案具 体内容如下:以公司 2024 年 12 月 31 日的总股本 383,949,815 股为基数,向全体 股东每 10 股派现金红利 1.35 元(含税),共派发现金红利总额为人民币 51,833,225.03 元(含税),不送红股,不以资本公积金转增股本。在利润分配预 案披露日至实施权益分派股权登记日期间,若公司总股本发生变化的,公司将按 照分配总额不变的原则对分 ...
美康生物(300439) - 关于公司取得医疗器械注册证的公告
2025-06-12 10:00
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:2025-039 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 | D-二聚体检测试剂 | 浙械注准 | 2025 年 6 月 6 日至 | 用于体外定量测定人血浆 | | | | 盒(胶乳免疫比浊法) | 20252401401 | 2030 年 6 月 5 日 | 中 D-二聚体的浓度。 | | 2 | 美康生物 | 脂蛋白(a)检测试剂 | 浙械注准 | 2025 年 6 月 6 日至 | 用于体外定量测定人血清 | | | | 盒(胶 ...
美康生物(300439) - 关于完成工商变更登记的公告
2025-06-12 10:00
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:2025-040 美康生物科技股份有限公司(以下简称"公司")于 2025 年 5 月 30 日召开 第五届董事会第十四次会议审议通过了《关于修订<公司章程>的议案》,鉴于公 司 2023 年限制性股票激励计划首次授予部分的第一个归属期归属条件已成就, 可归属的限制性股票共计 36.90 万股,公司已办理完成前述股份归属登记手续。 本次登记完成后,公司股本共计增加 36.90 万股,公司总股本由 38,394.9815 万 股变更为 38,431.8815 万股,注册资本由人民币 38,394.9815 万元变更为人民币 38,431.8815 万元。具体内容详见公司刊登在巨潮资讯网(www.cninfo.com.cn)的 相关公告(公告编号 2025-035)。 近日,上述事项的工商变更登记手续已在宁波市市场监督管理局办理完成, 公司取得了宁波市市场监督管理局换发的《营业执照》,《营业执照》上记载的 注册资本由人民币 383,949,815 元变更为人民币 384,318,815 元,其他登记事项不 变。 备查文件 1、《营业执 ...
美康生物(300439) - 关于使用部分闲置募集资金进行现金管理的进展公告
2025-06-06 09:45
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:2025-038 美康生物科技股份有限公司 关于使用部分闲置募集资金进行现金管理的进展公告 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。 单位:人民币万元 注:公司与上述产品受托人不存在关联关系。 1 / 4 美康生物科技股份有限公司 截至本公告披露日,公司除上述现金管理外,不存在其他使用闲置募集资金 进行现金管理的情况。 2025 年 5 月 30 日,美康生物科技股份有限公司(以下简称"公司")召开 第五届董事会第十四次会议、第五届监事会第十三次会议,分别审议通过了《关 于使用部分闲置募集资金进行现金管理的议案》,同意公司在保证募集资金投资 项目的资金需求以及募集资金使用计划正常进行的前提下,可以使用总金额不超 过人民币 10,000 万元的闲置募集资金进行现金管理,投资安全性高、流动性好 的投资产品,以增加公司收益。该资金额度自董事会审议通过之日起 12 个月内 可以滚动使用,并授权公司经营管理层行使决策权,公司财务部负责具体组织实 施。具体内容详见公司刊登在中国证券监督管 ...
美康生物携手北大一院获批国家重大专项 VAP精准血脂检测技术助力破解心脑血管残余风险
Quan Jing Wang· 2025-06-04 13:46
Group 1 - The core project "Research on Lipoprotein Profile and New Intervention Targets Based on Large Natural Population Cohorts" has been officially approved, aiming to address residual risk in atherosclerotic cardiovascular diseases using VAP precision lipid testing technology [1] - VAP precision lipid testing technology utilizes vertical density gradient centrifugation to quantitatively measure major components and subcomponents of lipoproteins in human serum or plasma, providing significant value in risk prediction and individualized treatment for cardiovascular diseases [1] - The company has obtained Class II medical device registration for VAP-related reagents and instruments, and its testing methods have been included in national clinical guidelines, enhancing market recognition and clinical application of precision lipid products [1] Group 2 - The company has over 20 years of experience in the IVD industry, with a comprehensive product line covering various technology platforms, making it one of the most complete and diverse IVD manufacturers in China [2] - The strategic layout of the company focuses on the synergy of diagnostic instruments, core diagnostic products, and diagnostic services, supported by multiple R&D centers and collaborations with universities and research institutions [2] - As of the end of 2024, the company has obtained 49 diagnostic instrument registration certificates and 459 supporting reagent registration certificates, covering essential equipment for various diagnostic needs [2] Group 3 - The company is the first Chinese IVD manufacturer to join JCTLM, promoting standardization and global recognition of test results, and has participated in the development of over 30 international and national standard materials [3] - The collaboration with Peking University First Hospital on the national major science and technology project signifies a breakthrough in the integration of industry, academia, and research [3] - The company plans to increase R&D investment and deepen technological innovation, aiming to contribute to chronic disease management and prevention in alignment with the "Healthy China 2030" strategy [3]
美康生物: 中天国富证券有限公司关于美康生物科技股份有限公司使用部分闲置募集资金进行现金管理的核查意见
Zheng Quan Zhi Xing· 2025-05-30 10:48
Summary of Key Points Core Viewpoint - The company plans to utilize part of its idle raised funds for cash management to enhance fund efficiency while ensuring that the investment projects' funding needs are met [1][4][7]. Group 1: Fundraising Overview - The company raised a total of RMB 599,999,925.00 by issuing 39,999,995 shares at RMB 15 per share, with a net amount of RMB 586,603,698.59 after deducting issuance costs [1]. - The funds are stored in a special account designated for this issuance, managed under a regulatory agreement with banks and the sponsor [2]. Group 2: Fund Utilization and Idle Reasons - As of May 29, 2025, the company has utilized RMB 58,660.37 million of the total RMB 62,233.01 million allocated for the in vitro diagnostic product R&D and industrialization project [2]. - The company anticipates temporary idleness of funds due to the phased nature of project construction, leading to a plan for cash management of idle funds [2][4]. Group 3: Previous Cash Management - The company previously approved the use of up to RMB 10,000 million of idle funds for cash management, with the authorization expiring on March 14, 2025 [3][4]. - The company has not engaged in further cash management activities since the expiration of the previous authorization [4]. Group 4: Current Cash Management Plan - The company intends to continue using up to RMB 10,000 million of idle funds for cash management, with the new authorization valid for 12 months from board approval [4][5]. - The investment will focus on low-risk financial products, ensuring no funds are used for high-risk securities or derivatives [5][6]. Group 5: Decision-Making Process - The board and supervisory committee have approved the cash management plan, ensuring it aligns with regulatory requirements and does not harm shareholder interests [6][7]. - The company will maintain strict oversight and risk control measures during the investment process [6][7].
美康生物: 第五届监事会第十三次会议决议公告
Zheng Quan Zhi Xing· 2025-05-30 10:37
Core Viewpoint - The company has approved the use of idle raised funds for cash management, which is expected to enhance the efficiency of fund utilization and provide better returns for shareholders without affecting the company's normal operations or main business development [1][2]. Group 1 - The fifth session of the company's supervisory board was held on May 30, 2025, with all legal requirements met for the meeting [1]. - The supervisory board unanimously approved the proposal to use up to RMB 100 million of temporarily idle raised funds for cash management [1]. - The decision is in compliance with relevant regulations and will not harm the interests of the company or its shareholders, particularly minority shareholders [1][2]. Group 2 - The voting results for the proposal were 3 votes in favor, 0 votes against, and 0 abstentions [2]. - The company will ensure that the use of these funds does not impact the normal turnover of funds or the implementation of investment projects [1]. - The decision aligns with various regulatory guidelines and the company's articles of association [1].