Core Viewpoint - The approval of the "Coronary Scoring Balloon Dilatation Catheter" by the National Medical Products Administration (NMPA) represents a significant advancement for the company in providing effective solutions for complex coronary artery diseases [1][2]. Product Information - The product, named "Star Scar," features a unique spiral triangular scoring wire that allows for 360° efficient pressure-focused dilation [1]. - It is the only coronary scoring balloon with up to four scoring wires, providing a larger scoring area and a rated burst pressure (RBP) of up to 20 atm, enhancing safety during expansion [1]. - The device is particularly advantageous for treating calcified and high-resistance complex lesions, offering a safer and more ideal choice for coronary intervention [1]. Impact on the Company - The successful approval of the Star Scar catheter not only provides a precise and efficient pre-dilation option for complex coronary artery lesions but also completes the strategic puzzle for the company's cardiovascular division in constructing a "PCI optimization full-link solution" [2]. - This development is expected to positively influence the company's operational growth by enabling a comprehensive solution for both simple and complex lesions in PCI treatments [2].

Core Viewpoint - Blue Sail Medical (002382.SZ) has received the medical device registration certificate from the National Medical Products Administration (NMPA) for its self-developed and produced Class III medical device, the "Coronary Scoring Balloon Dilatation Catheter" (branded as "Star Scar™") [1] Group 1: Product Features - The Star Scar™ catheter features a unique spiral-wound triangular scoring wire that allows for 360° efficient pressure-focused dilation [1] - It is the market's highest with four scoring wires, providing a larger scoring area and a rated burst pressure (RBP) of up to 20 atm, which offers a higher safety expansion margin [1] - The device excels in reducing the incidence of dissection and optimizing vascular preparation, particularly advantageous for complex lesions such as calcification [1] Group 2: Market Implications - The introduction of the Star Scar™ catheter provides a safer and more ideal option for coronary intervention treatments [1]

格隆汇12月11日丨蓝帆医疗(002382.SZ)公布，公司心脑血管事业部子公司山东吉威医疗制品有限公司 自主研发和生产的三类医疗器械产品"冠状动脉刻痕球囊扩张导管"（简称"星痕™"）通过国家药品监督 管理局（NMPA）的审查，正式获得中华人民共和国医疗器械注册证。星痕™冠状动脉刻痕球囊扩张导 管具有独特的螺旋环绕三角刻痕丝，可实现360°高效压力聚焦扩张；作为市场上最高 4 根刻痕丝的冠脉 刻痕球囊，具有更大的刻痕面积，额定爆破压力（RBP）高达 20atm，可以提供更高的安全扩张空间， 在降低夹层发生率、优化血管准备方面表现卓越，对于钙化等高阻力复杂病变，其优势尤为显著，为冠 状动脉介入治疗提供了更安全、更理想的选择。 ...

Core Viewpoint - The company, Bluestar Medical (002382.SZ), has successfully obtained a medical device registration certificate from the National Medical Products Administration (NMPA) for its self-developed and produced Class III medical device, the "Coronary Artery Scoring Balloon Dilatation Catheter" Group 1 - The product is developed and manufactured by the company's subsidiary, Shandong Jiwei Medical Products Co., Ltd. [1] - The approval signifies a significant milestone for the company's cardiovascular division [1]

Core Viewpoint - Blue Sail Medical (002382.SZ) announced that its subsidiary, Shandong Jiwei Medical Products Co., Ltd., has successfully developed and produced a Class III medical device, the "Coronary Angioplasty Balloon Catheter," which has received the medical device registration certificate from the National Medical Products Administration (NMPA) [1] Group 1 - The product is categorized as a Class III medical device, indicating its high risk and the need for stringent regulatory oversight [1] - The approval from NMPA marks a significant milestone for the company in expanding its product offerings in the cardiovascular sector [1] - This development may enhance the company's competitive position in the medical device market, particularly in cardiovascular treatments [1]

证券代码：002382 证券简称：蓝帆医疗 公告编号：2025-097 债券代码：128108 债券简称：蓝帆转债 蓝帆医疗股份有限公司 中国 NMPA 注册的公告 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。 关于子公司冠状动脉刻痕球囊扩张导管获得 近日，蓝帆医疗股份有限公司（以下简称"公司"）接到通知，公司心脑血管事业 部子公司山东吉威医疗制品有限公司自主研发和生产的三类医疗器械产品"冠状动脉 刻痕球囊扩张导管"（以下简称"星痕™"）通过国家药品监督管理局（NMPA）的审查， 正式获得中华人民共和国医疗器械注册证。现将相关情况公告如下： 一、获批产品基本信息 产品名称：冠状动脉刻痕球囊扩张导管 注册人名称：山东吉威医疗制品有限公司 注册证编号：国械注准20253032515 星痕™冠状动脉刻痕球囊扩张导管的成功获批，不仅为临床处理复杂冠状动脉病 1 变提供了又一精准高效的预扩张选择，也标志着蓝帆医疗心脑血管事业部在构建"PCI 优化全链路解决方案"的战略拼图更加完整，在 PCI 治疗中进一步成功实现从简单到 复杂病变整体解决方案的"一站式"供应，预期将对 ...

| 证券代码：002382 | 证券简称：蓝帆医疗 | 公告编号：2025-096 | | --- | --- | --- | | 债券代码：128108 | 债券简称：蓝帆转债 | | 蓝帆医疗股份有限公司 关于子公司为公司向银行申请授信提供担保的进展公告 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。 一、担保情况概述 限公司与浙商银行股份有限公司济南分行签订了《最高额抵押合同》，山东蓝帆新材料 有限公司为公司向浙商银行股份有限公司济南分行申请授信提供不动产抵押担保。 本次担保金额全部发生后未超过公司第六届董事会第十六次会议、2024年第三次 临时股东大会审议通过的2025年度公司及子公司申请授信及担保额度的金额范围，无 需另行召开董事会或股东会审议。 截至本公告发布之日，公司在2024年第三次临时股东大会批准范围内担保额度及 使用情况如下： 单位：万元人民币 | 新增担 | 是 | 被担保 | 本次担保 | 保额度 | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | ...

Group 1 - The company plans to apply for a total credit limit of up to RMB 1.71 billion for 2025, which includes various types of financing such as working capital loans and bank guarantees [2] - The company will provide guarantees totaling up to RMB 1.71 billion, with RMB 1.544 billion allocated for subsidiaries with a debt-to-asset ratio below 70% and RMB 166 million for those above [2] - The guarantee period is valid for 12 months from the date of the shareholders' meeting resolution [2] Group 2 - The company's wholly-owned subsidiary, Shandong Lanfang New Materials Co., Ltd., has applied for a working capital loan of RMB 87.5 million from Industrial Bank Co., Ltd. [4] - A guarantee contract has been signed between the company and Industrial Bank for the loan, providing joint liability guarantee [4][9] - The total amount of guarantees provided by the company and its subsidiaries will not exceed RMB 3.341 billion, which is 40.81% of the company's audited net assets for 2024 [11]

证券日报网讯 12月5日晚间，蓝帆医疗发布公告称，近日公司为全资子公司山东蓝帆新材料有限公司向 兴业银行淄博分行申请8，750万元流动资金借款提供连带责任担保，本次担保后山东新材料担保余额升 至30，246万元，剩余可用担保额度82，789.77万元；截至公告日，公司及子公司担保最高额334， 114.31万元，占2024年度经审计净资产40.81%，无逾期担保。 （文章来源：证券日报） ...

| 证券代码：002382 | 证券简称：蓝帆医疗 | 公告编号：2025-095 | | --- | --- | --- | | 债券代码：128108 | 债券简称：蓝帆转债 | | 蓝帆医疗股份有限公司 关于公司为子公司向银行申请授信提供担保的进展公告 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。 一、担保情况概述 蓝帆医疗股份有限公司（以下简称"公司"）于2024年12月6日召开了第六届董事 会第十六次会议、2024年12月23日召开了2024年第三次临时股东大会，审议并通过了 《关于2025年度公司及子公司申请授信及担保额度预计的议案》，公司及子公司2025 年度拟向银行等金融机构申请综合授信总额不超过人民币17.10亿元，授信品种包括但 不限于流动资金贷款、保函、银行承兑汇票、国内信用证、国内保理、融资租赁等综 合授信业务（具体业务品种以相关金融机构审批为准），具体融资金额将视公司及子 公司生产运营对资金的需求来确定。公司及子公司将根据金融机构的授信要求为上述 综合授信提供担保额度总计不超过人民币17.10亿元，其中，预计为公司及资产负债率 70 ...