海通证券股份有限公司 | 项目 | 工作内容 | | --- | --- | | （2）发表非同意意见所涉问题及结论意见 | 不适用 | | 7、向本所报告情况（现场检查报告除外） | | | （1）向本所报告的次数 | 次 0 | | （2）报告事项的主要内容 | 不适用 | | （3）报告事项的进展或者整改情况 | 不适用 | | 8、关注职责的履行情况 | | | （1）是否存在需要关注的事项 | 否 | | （2）关注事项的主要内容 | 不适用 | | （3）关注事项的进展或者整改情况 | 不适用 | | 9、保荐业务工作底稿记录、保管是否合规 | 是 | | 10、对上市公司培训情况 | | | （1）培训次数 | 2 次 | | （2）培训日期 | 年 月 年 月 2023 5 22 日/2023 12 | | | 日 21 | | （3）培训的主要内容 | 《上市公司治理与规范运作理 论、实务及案例分析》/《2023 | | | 年度持续督导培训》 | | 11、其他需要说明的保荐工作情况 | 无 | 二、保荐机构发现公司存在的问题及采取的措施 | 事项 | 存在的问题 | 采取的措施 | | ...

乐心医疗 2024 年公告 证券代码：300562 证券简称：乐心医疗 公告编号：2024-044 广东乐心医疗电子股份有限公司 关于申报医疗器械注册证获得受理的公告 广东乐心医疗电子股份有限公司（以下简称"公司"）近日收到加拿大卫生局 医疗器械部设备许可服务科（Bureau of Licensing Services, Medical Devices Directorate, Health Canada -Santé Canada）的回复，获悉公司申报的电子血压计医 疗器械注册申请事宜已获受理，现将相关内容公告如下： | 产品名称 | 申请事项 | 受理号 | 注册 分类 | 结构组成 | 规格、型号 | 适用范围 | | --- | --- | --- | --- | --- | --- | --- | | 电子血压 | 首次注册 | 375783 | II 类 | 由主机、袖 | BT106 | 本产品适用于测量臂围 在 22cm-45cm 的成人的 | | 计 | 申请 | | | 带组成。 | （TMB-995-GS) | 血压和脉率，其数值供 | | | | | | | | 诊断参考用。 | 上述 ...

| 产品名称 | 申请事项 | 证书编号 | 注册 分类 | 主要变更内容 | 结构组成 | 适用范围 | | --- | --- | --- | --- | --- | --- | --- | | 电子血压 | 变更注册 | G10 082800 | IIa 类 | 在产品型号列表中新增 | | 适用臂围为 | | | | | | 产品型号：BBZ32-AA01、 | | 22cm-32cm、 | | | | | | BBZ32-AB01、 | 主要由主机 | 22cm-42cm 的 | | 计 | | 0048 Rev.00 | | BBZ32-BB01、 | 和袖带组成。 | 成人室内测量 | | | | | | BBZ32-DA01、 | | 收缩压、舒张 | | | | | | BBZ32-DB01 | | 压及脉率。 | 乐心医疗 2024 年公告 证券代码：300562 证券简称：乐心医疗 公告编号：2024-043 广东乐心医疗电子股份有限公司 关于完成医疗器械注册证变更的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚 假记载、误导性陈述或重大遗漏。 广东乐心医疗电子股 ...

乐心医疗 2024 年公告 证券代码：300562 证券简称：乐心医疗 公告编号：2024-042 广东乐心医疗电子股份有限公司 乐心医疗 2024 年公告 关于回购公司股份的进展公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚 假记载、误导性陈述或重大遗漏。 广东乐心医疗电子股份有限公司（以下简称"公司"）于 2024 年 02 月 01 日召开第四届董事会第十二次会议与第四届监事会第十一次会议，审议通过了 《关于回购公司股份方案的议案》，同意公司使用自有资金回购公司股份用于股 权激励或员工持股计划。本次回购拟使用的总金额不低于人民币 2,000 万元（含 本数）且不超过人民币 4,000 万元（含本数），回购价格不高于人民币 16.00 元/ 股（含）。 具体内容详见公司于 2024 年 02 月 01 日 在 巨 潮 资 讯网 （www.cninfo.com.cn）披露的《关于回购公司股份方案的公告》（公告编号：2024- 014）。 2024 年 02 月 07 日，公司披露了《关于首次回购公司股份的公告》（公告 编号：2024-018），具体详见公司在巨潮资讯网（www.cni ...

乐心医疗 2024 年公告 广东乐心医疗电子股份有限公司 关于申报医疗器械注册证获得受理的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚 假记载、误导性陈述或重大遗漏。 广东乐心医疗电子股份有限公司（以下简称"公司"）近日收到美国 FDA 发 出的《Acknowledgement Letter》，获悉公司申报的电子血压计医疗器械 510(k)注 册申请已获受理，现将相关内容公告如下： 上述医疗器械注册申请事宜目前尚处于受理阶段，后续仍需相关部门进一步 核准认证，评审在各阶段所需的时间和结果均具有一定的不确定性。公司目前尚 无法预测其对公司未来业绩的影响，敬请广大投资者注意投资风险。 乐心医疗 2024 年公告 证券代码：300562 证券简称：乐心医疗 公告编号：2024-041 | 产品名称 | 申请事项 | 受理号 | 注册 分类 | 结构组成 | 规格、型号 | 适用范围 | | --- | --- | --- | --- | --- | --- | --- | | 电子 | 首次注册 | | 类 | 由主机、袖 | | 本产品适用于测量臂围 在 22cm-32cm、22cm | ...

相对估值：11.57-12.03 元 公司主要的应收来自于医疗级设备及可穿戴设备，其中包括与 TWS 耳机、助听器、 医疗检测设备等。目前，缺少和公司业务高速类似的上市公司，我们选择了具有 部分业务重叠的厂商作为可比公司，包括歌尔股份、天健股份、鱼跃医疗。 歌尔股份：公司主要从事声学、传感器、光电、3D 封装模组等精密零组件，以及 虚拟/增强现实、智能穿戴、TWS、机器人等智能硬件的研发、制造和品牌营销。 目前已在多个领域建立了全球领先的综合竞争力。 天键股份：公司有注塑、喇叭、SMT 贴片、成品组装、包装等生产车间，每年可 完成 TWS 耳机/头戴式耳机/入耳式耳机等声学产品超过 2,000 万部。公司建立了 焊接标准、超声标准、点胶标准等成熟的耳机生产工艺和工艺标准。 鱼跃医疗：公司是一家以提供家用医疗器械、医用临床器械和互联网医疗服务为 主要业务的公司，而研发、制造和销售医疗器械产品是公司目前的核心业务，也 是目前公司主要业绩来源。公司器械产品主要集中在呼吸供氧、康复护理、手术 器械、高值耗材、中医诊疗器械、药用贴膏及高分子卫生辅料等领域。 相较于以 TWS 耳机等可穿戴设备为主的可比公司，或是专业做医 ...

Financial Performance - The company's operating revenue for 2023 was approximately ¥884.26 million, a decrease of 16.98% compared to ¥1,065.10 million in 2022[38]. - The net profit attributable to shareholders for 2023 was approximately ¥34.37 million, a significant increase of 206.21% from a loss of ¥32.29 million in 2022[38]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was approximately ¥22.54 million, up 159.93% from a loss of ¥37.55 million in 2022[38]. - The basic earnings per share for 2023 was ¥0.1597, compared to a loss of ¥0.1500 in 2022, marking a 206.47% increase[38]. - The total assets at the end of 2023 were approximately ¥1,556.50 million, reflecting a slight increase of 0.59% from ¥1,547.24 million at the end of 2022[38]. - The net assets attributable to shareholders at the end of 2023 were approximately ¥1,040.60 million, an increase of 2.81% from ¥1,012.06 million at the end of 2022[38]. - The net cash flow from operating activities for 2023 was approximately ¥74.14 million, a decrease of 12.41% from ¥84.65 million in 2022[38]. - The company reported a total net profit of -¥12,098,183.90 in the first quarter, highlighting challenges faced at the beginning of the year[46]. - The company has experienced a negative net profit for the last three accounting years when excluding non-recurring gains and losses, raising concerns about its going concern ability[42]. Dividend and Shareholder Returns - The company plans to distribute a cash dividend of RMB 1.50 per 10 shares, totaling RMB 32,535,178.20 for the fiscal year 2023[15]. Market Expansion and Strategy - The company is focusing on expanding its overseas market presence, particularly in North America, Europe, and Asia-Pacific, which significantly contributes to its revenue[9]. - The company acknowledges the risks associated with international trade policies and aims to adapt its strategies accordingly to ensure stable overseas operations[9]. - Future outlook includes strategic initiatives for market expansion and potential mergers and acquisitions to enhance growth opportunities[38]. - The company is focusing on expanding its presence in emerging markets such as the Middle East and Latin America while enhancing its local sales and service teams[98]. - The company has established deep collaborations with leading RPM clients in Europe and the US, such as Teladoc and Livongo, indicating strong future growth potential[72]. Product Development and Innovation - The company aims to improve its product development capabilities by investing in high-quality R&D talent and enhancing its hardware laboratory facilities[11]. - The company continues to focus on the development of new products and technologies in the IoT sector, aiming to expand its market presence[38]. - The company has introduced new product categories including smart blood glucose meters and OTC hearing aids, enhancing its health IoT product line[68]. - The company is focused on integrating AI and big data into its healthcare services, aligning with national strategies for health and digital development[64]. - The company has developed a standardized digital health management platform that serves various industries, aiming to reduce costs and enhance operational efficiency[79]. - The company has successfully developed various terminal devices in the remote health sector, including blood pressure monitors and smart scales, leveraging edge computing for enhanced system capabilities[135]. - The company has completed the development of a flagship blood pressure monitor that enhances measurement accuracy and stability, enabling precise measurement of various hypertension types[139]. - The company has developed a wearable ECG product that supports 12 leads, enhancing heart health monitoring capabilities and improving overall competitiveness[143]. Research and Development - R&D investment totaled 10,832.33 million yuan, representing 12.25% of the company's revenue during the reporting period, emphasizing the commitment to innovation[88]. - The company has built a comprehensive capability matrix integrating hardware, sensors, algorithms, big data, AI, and cloud computing to establish a differentiated competitive edge[84]. - The company has completed research on blood pressure measurement technologies tailored for special populations, such as pregnant women and diabetics[149]. - The R&D team has focused on improving sensor precision for household electronic scales, achieving a target accuracy of 1%[149]. - The company aims to leverage AI in ECG analysis to enhance product competitiveness and overall market strength[143]. Cost Management and Efficiency - The company is implementing cost control measures to mitigate risks associated with rising raw material and labor costs[12]. - The overall cost of sales decreased by 24.86% to ¥812.72 million, reflecting a strategic focus on cost management[126]. - The company is implementing cost reduction and efficiency improvement strategies, optimizing production processes and supply chain management to enhance competitiveness[112]. Regulatory Compliance and Certifications - The company has received Class II medical device certification for several products, including electronic blood pressure monitors and smart ECG patches, ensuring compliance with regulatory standards[67]. - The company has obtained FDA registration for multiple electronic blood pressure monitors, including models TMB-986 and TMB-987, which are used for measuring systolic and diastolic blood pressure and pulse rate[163]. - The company has received CE certification for its electronic blood pressure monitors, with the latest certification valid until May 26, 2024, indicating compliance with European health and safety standards[166]. Government Support and Subsidies - The company reported a government subsidy of ¥8,397,619.21 in 2023, which is crucial for its operational support[50]. - The company received government subsidies amounting to ¥9,080,006.87, which accounted for 27.42% of total profit[171]. Cash Flow and Financial Management - The net cash flow from operating activities decreased by 34.32% to ¥955,198,924.67 in 2023 compared to ¥1,454,232,776.21 in 2022[169]. - The net cash flow from investing activities increased significantly by 214.01% to ¥1,152,605,295.64 in 2023 from ¥367,060,688.00 in 2022[169]. - The net cash flow from financing activities turned negative, with a net outflow of ¥11,400,033.99 in 2023, a decrease of 110.62% compared to a net inflow of ¥107,375,553.72 in 2022[169]. Market Trends and Projections - The global medical device market is projected to grow from approximately $570 billion in 2022 to $884.8 billion by 2030, with a compound annual growth rate (CAGR) of 5.8%[55]. - The Chinese medical device market reached ¥957.3 billion (approximately $133 billion) in 2022, accounting for 23.3% of the global market[55]. - The wearable medical device market in China is expected to reach ¥144.16 billion by 2025, with a CAGR of 21.9%[56]. - The digital healthcare market in China is projected to reach RMB 284.4 billion in 2023 and further grow to RMB 413 billion in 2024, indicating a significant expansion in the sector[60]. - The global telemedicine market reached RMB 12.31 billion in 2022 and is expected to grow at a CAGR of 24.58%, reaching RMB 46.854 billion by 2028[63]. Risk Management - The company is strengthening its foreign exchange risk management to address potential impacts from currency fluctuations on its profitability[13]. - The company has implemented risk control measures, including careful selection of trading counterparties and maintaining a balance between foreign exchange assets and liabilities[183]. Corporate Governance - The company has improved its governance structure and investor relations, enhancing communication with investors through various channels[118]. - The company has strengthened its internal control systems to mitigate risks and enhance operational efficiency[119].

对外担保管理制度 广东乐心医疗电子股份有限公司 对外担保管理制度 第一章 总 则 第一条 为规范广东乐心医疗电子股份有限公司(以下简称公司)对外担保的管理，控制和降 低担保风险，保障公司资产安全，根据《中华人民共和国公司法》《上市公司监管指引第8号— —上市公司资金往来、对外担保的监管要求》《深圳证券交易所创业板股票上市规则》以及 《广东乐心医疗电子股份有限公司章程》（以下简称"《公司章程》"）的有关规定，结合公 司的实际情况，特制定本制度。 第二条 制度所称对外担保是指公司为他人提供的担保，包括公司对控股子公司的担保。 第三条 公司对外担保应当遵循安全、平等、自愿、公平、诚信、互利的原则。公司有权拒 绝任何强令其为他人提供担保的行为。 第四条 公司对外担保实行统一管理，非经公司董事会或股东大会批准、授权，任何人无权 以公司名义签署对外担保的合同协议或其他类似的法律文件。 第六条 公司董事和高级管理人员应审慎对待和严格控制担保产生的债务风险，并对违规或 失当的对外担保产生的损失依法承担连带责任。 第二章 对外担保对象的审查 第七条 公司可以为具有独立法人资格且具有下列条件之一的单位担保： 第 1 页 （一）因 ...

2023 年 1-12 月，公司募集资金专户收到的利息及理财收入扣除银行手续费 后的净额为 5,238,591.32 元；公司实际使用募集资金 35,266,596.99 元；截至 2023 年 12 月 31 日止，公司募集资金余额为 207,454,581.87 元（包括收到的银行存款 利息扣除银行手续费等的净额），其中募集专户余额 180,454,581.87 元，封闭性 理财账户余额 27,000,000.00 元。 关于2023年度募集资金存放与实际使用情况的专项报告 根据中国证券监督管理委员会《上市公司监管指引第 2 号——上市公司募集 资金管理和使用的监管要求（2022 年修订）》（证监会公告〔2022〕15 号）、 《深圳证券交易所上市公司自律监管指引第 2 号——创业板上市公司规范运作》 以及《深圳证券交易所创业板上市公司自律监管指南第 2 号——公告格式（2023 年修订）》的相关规定，本公司就 2023 年度募集资金存放与实际使用情况作如 下专项报告： 一、募集资金基本情况 （一）实际募集资金金额、资金到位情况 关于 2023 年度募集资金存放与实际使用情况的专项报告 广东乐心医疗电子股 ...

董事会审计委员会议事规则 广东乐心医疗电子股份有限公司 第一章 总则 第一条 为强化公司董事会决策功能，促进公司审计工作的有效进行，做到审计工作事前准备、 审计过程执行到位、审计事项后续改进的全面开展，确保董事会对经营层的有效监督，完善公司 治理结构，根据《中华人民共和国公司法》、《上市公司治理准则》、《广东乐心医疗电子股份有限 公司章程》（以下简称"《公司章程》"）及其他有关规定，公司特设立董事会审计委员会（以下简 称"审计委员会"），并制定本实施细则。 第二条 审计委员会是董事会依据相应法律法规设立的专门工作机构，主要负责公司内、外部 审计的沟通、监督和核查工作，对董事会负责。 第二章 人员组成 董事会审计委员会议事规则 第三条 审计委员会成员由董事会从董事会成员中任命，并由 3 名成员组成。审计委员会成员 应当勤勉尽责，切实有效地监督、评估上市公司内外部审计工作，促进公司建立有效的内部控制 并提供真实、准确、完整的财务报告。 第四条 审计委员会成员原则上须独立于公司的日常经营管理事务。审计委员会成员应当为不 在公司担任高级管理人员的董事，其中独立董事委员应当占审计委员会成员总数的 1/2 以上。 第五条 ...