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拱东医疗:2023年第一次临时股东大会法律意见书
2023-09-12 08:56
下 天册律师事务所 下 & C LAW FIRM 法律意见书 浙江天册律师事务所 关于 浙江拱东医疗器械股份有限公司 2023 年第一次临时股东大会的 法律意见书 下 天册律师事务所 T & C LAW FIRM 浙江省杭州市杭大路 1 号黄龙世纪广场 A 座 11 楼 310007 电话: 0571-87901111 传真: 0571-87901500 下 天册律师事务所 法律意见书 浙江天册律师事务所 关于浙江拱东医疗器械股份有限公司 2023 年第一次临时股东大会的 法律意见书 编号:TCYJS2023H1343 号 致:浙江拱东医疗器械股份有限公司 浙江天册律师事务所(以下简称"本所")接受浙江拱东医疗器械股份有限 公司(以下简称"拱东医疗"或"公司"的委托,指派本所律师参加公司 2023 年第一次临时股东大会,并根据《中华人民共和国证券法》(以下简称"《证券 法》")、《中华人民共和国公司法》(以下简称"《公司法》")和中国证券监 督管理委员会关于《上市公司股东大会规则(2022年修订)》( 以下简称"《股东 大会规则》")等法律、行政法规和其他规范性文件的要求出具本法律意见书。 在本法律意见书中, ...
拱东医疗:关于召开2023年半年度业绩说明会的公告
2023-09-11 07:38
证券代码:605369 证券简称:拱东医疗 公告编号:2023-035 浙江拱东医疗器械股份有限公司 关于召开 2023 年半年度业绩说明会的公告 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。 重要内容提示: 浙江拱东医疗器械股份有限公司(以下简称"公司")已于 2023 年 8 月 26 日发布公司 2023 年半年度报告,为便于广大投资者更全面深入地了解公司 2023 年半年度经营成果、财务状况,公司计划于 2023 年 09 月 21 日下午 13:00-14:00 举行 2023 年半年度业绩说明会,就投资者关心的问题进行交流。 一、 说明会类型 本次投资者说明会以网络互动形式召开,公司将针对 2023 年半年度的经营 成果、财务指标及现金分红的具体情况与投资者进行互动交流和沟通,在信息 披露允许的范围内就投资者普遍关注的问题进行回答。 | 董事长: | 施慧勇 | | | --- | --- | --- | | 董事、总经理: | 钟卫峰 | | | 董事、董事会秘书:金世伟 | | | | 财务总监: 潘 | | ...
拱东医疗:2023年第一次临时股东大会会议资料
2023-08-29 07:38
浙江拱东医疗器械股份有限公司 (浙江省台州市黄岩区北院大道 10 号) 2023 年第一次临时股东大会 3、股东或股东代理人发言前认真做好准备,每一股东或股东代理人发言不 得超过 3 分钟。主持人可安排公司相关人员回答股东问题,与本次股东大会议 题无关或将泄露公司商业秘密或损害公司、股东共同利益的,大会主持人或其 指定的有关人员有权拒绝回答。议案表决开始后,大会将不再安排股东发言。 4、本次股东大会由两名股东代表、一名监事代表和见证律师参加计票、监 票,对投票和计票过程进行监督,由主持人公布表决结果。 会议资料 2023 年 9 月 | 2023 | 年第一次临时股东大会会议须知 1 | | --- | --- | | 2023 | 年第一次临时股东大会议程 2 | | | 会议议案 3 | | | 议案一 4 | 浙江拱东医疗器械股份有限公司 2023 年第一次临时股东大会会议须知 为维护股东的合法权益,确保会议秩序和议事效率,根据《公司法》《公司 章程》及《公司股东大会议事规则》等有关规定,特制定本次会议须知: 1、出席会议的股东或股东代理人需提交身份证明材料原件,经律师验证后 办理签到手续并领取会议资料 ...
拱东医疗(605369) - 2023 Q2 - 季度财报
2023-08-25 16:00
Financial Performance - Revenue for the first half of 2023 was RMB 458.2072 million, a decrease of 42.65% compared to the same period last year[72] - Net profit attributable to shareholders was RMB 60.9554 million, down 71.05% year-on-year[72] - Basic earnings per share (EPS) for the reporting period was RMB 0.54, a decrease of 71.12% compared to the same period last year[73] - Total revenue for the first half of 2023 was RMB 832.85 million, a decrease from RMB 1.13 billion in the same period last year[157] - Net profit for the first half of 2023 was 60,955,439.49 RMB, compared to 210,549,069.63 RMB in the same period last year[162] - Operating profit for the first half of 2023 was 68,402,557.88 RMB, down from 243,941,625.61 RMB in the same period last year[162] - Total operating revenue for the first half of 2023 was RMB 458.21 million, a decrease of 42.7% compared to RMB 798.97 million in the same period of 2022[189] - Net profit attributable to the parent company for the first half of 2023 was RMB 73.90 million, a decrease of 65.0% compared to RMB 211.07 million in the same period of 2022[190] - Basic earnings per share for the first half of 2023 were RMB 0.54, down 71.1% from RMB 1.87 in the same period of 2022[190] Cash Flow and Liquidity - Sales revenue from goods and services received in cash decreased to 461,692,642.72 yuan in the first half of 2023, compared to 785,246,578.45 yuan in the same period of 2022[28] - Total cash inflow from operating activities dropped to 475,556,457.48 yuan in the first half of 2023 from 796,357,597.17 yuan in the first half of 2022[28] - Cash paid for goods and services decreased to 214,223,902.60 yuan in the first half of 2023, compared to 482,842,704.34 yuan in the same period of 2022[28] - Net cash flow from operating activities declined to 90,728,940.34 yuan in the first half of 2023 from 114,896,331.00 yuan in the first half of 2022[29] - Cash outflow for investment activities increased to 51,366,239.40 yuan in the first half of 2023, compared to 112,557,907.31 yuan in the same period of 2022[29] - Total cash outflow from operating activities was RMB 395.94 million, a decrease of 41.9% compared to the previous period[40] - Net cash flow from operating activities was RMB 79.61 million, a decrease of 30.3% compared to the previous period[40] - Net cash flow from investing activities was negative RMB 340.33 million, a significant increase in outflow compared to the previous period's negative RMB 69.15 million[40] - Net cash flow from financing activities was negative RMB 34.12 million, a decrease in outflow compared to the previous period's negative RMB 144.35 million[40] - Cash and cash equivalents at the end of the period were RMB 379.62 million, a decrease of 44.4% compared to the beginning of the period[41] - Cash and cash equivalents decreased to RMB 462.48 million from RMB 753.23 million at the end of 2022[157] - Cash and cash equivalents at the end of June 2023 were RMB 412.48 million, a decrease of 34.1% from RMB 626.24 million at the end of June 2022[193] Assets and Liabilities - The company's monetary funds decreased by 38.60% to 46.24758 million, accounting for 25.04% of total assets, mainly due to the payment for the acquisition of TPI's core assets[2] - Accounts receivable decreased by 8.94% to 21.72836 million, accounting for 11.77% of total assets, mainly due to the recovery of previous accounts receivable[2] - Fixed assets increased by 7.64% to 62.57894 million, accounting for 33.89% of total assets, mainly due to the acquisition of TPI's core assets[2] - Intangible assets increased by 36.19% to 10.78647 million, accounting for 5.84% of total assets, mainly due to the acquisition of TPI's core assets[2] - The company's total assets at the end of the reporting period were RMB 1.8466494 billion, a decrease of 1.12% compared to the end of the previous year[72] - Total assets decreased from 1,885,308,721.13 RMB to 1,824,880,633.30 RMB[160] - Total assets as of June 30, 2023 were RMB 1.85 billion, a slight decrease of 1.1% from RMB 1.87 billion at the end of 2022[186] - Total liabilities as of June 30, 2023 were RMB 183.08 million, a decrease of 33.4% from RMB 274.72 million at the end of 2022[188] - Total current liabilities decreased to RMB 188.53 million from RMB 262.89 million at the end of 2022[158] - Deferred income tax liabilities increased to RMB 18.66 million from RMB 10.26 million at the end of 2022[158] - Total liabilities and owner's equity amounted to 1,824,880,633.30 RMB[161] - Owner's equity increased slightly from 1,610,585,562.94 RMB to 1,641,801,984.56 RMB[161] - Fixed assets increased from 576,555,091.20 RMB to 584,014,025.86 RMB[160] - Construction in progress decreased from 28,337,376.34 RMB to 25,589,800.75 RMB[160] - Intangible assets decreased from 79,200,916.19 RMB to 77,994,095.26 RMB[160] - Deferred tax assets decreased from 3,215,814.56 RMB to 2,595,753.79 RMB[160] - Other non-current assets remained unchanged at 4,014,024.66 RMB[160] - The total fixed assets of the company amount to 625,789,354.30[185] - The total intangible assets of the company amount to 107,864,696.92[185] - The total non-current assets of the company amount to 1,013,797,050.02[185] - Accounts receivable as of June 30, 2023 were RMB 185.60 million, a decrease of 22.8% from RMB 240.56 million at the end of 2022[187] - Inventory as of June 30, 2023 was RMB 99.25 million, a decrease of 17.1% from RMB 119.71 million at the end of 2022[187] - Total equity attributable to the parent company as of June 30, 2023 was RMB 1.64 billion, an increase of 2.8% from RMB 1.59 billion at the end of 2022[186] - The company's total equity at the end of the period was 1,637,451,857.70[195] - The company's total equity at the end of the period was 1,641,801,984.56[197] - The company's total equity at the end of the period was 1,472,590,226.09[198] Investments and Acquisitions - The company invested $45 million in its wholly-owned subsidiary GD Medical to acquire TPI's core assets[5] - The company invested RMB 287.68 million in financial assets, a significant increase compared to the previous period's RMB 121.00 million[40] - The company's capital expenditure (purchase of fixed assets, intangible assets, and other long-term assets) was RMB 52.66 million, a decrease of 53.2% compared to the previous period[40] - GD Medical completed the acquisition of TPI and was renamed Trademark Plastics Inc. in February 2023[125] - The fair value of trading financial liabilities decreased by 1,060,175.50, and trading financial assets increased by 11,000,000.00[126] Shareholder and Stock Information - The company unlocked 178,236 restricted shares for 63 incentive targets as part of its 2021 restricted stock incentive plan, with the adjusted repurchase price set at 49.13 yuan per share[14] - The company's controlling shareholders and actual controllers have committed to not transferring or entrusting others to manage their shares for 36 months after the IPO, with an automatic extension of 6 months if the stock price falls below the issue price for 20 consecutive trading days[18] - Directors, supervisors, and senior management have committed to not transferring their shares in Jincheng Investment for 36 months after the IPO, with a limit of 25% of their holdings per year after the lock-up period[19] - The controlling shareholder has committed to stabilizing the stock price by increasing holdings if the closing price is below the audited net asset value per share for 20 consecutive trading days within three years of listing[20] - Jincheng Investment has committed to not transferring its shares for 36 months after the IPO, with an automatic extension of 6 months if the stock price falls below the issue price for 20 consecutive trading days[22] - Directors and senior management have committed to stabilizing the stock price by increasing holdings if the closing price is below the audited net asset value per share for 20 consecutive trading days within three years of listing[24] - The company's registered capital is 112,627,120 yuan, with a total of 112,627,120 shares issued[35] - The top shareholder, Hong Kong Securities Clearing Company, held 835,296 shares, representing 0.74% of total shares[152] - The second-largest shareholder, Lian Zhongming, held 616,326 shares, representing 0.55% of total shares[152] - The company's total equity remained stable at RMB 112.63 million[158] - The company's limited-sale shares decreased by 10,500 shares, resulting in a total of 84,378,972 shares, maintaining a 74.92% ownership ratio[176] - The company's unrestricted shares increased by 10,500 shares, totaling 28,248,148 shares, with a 25.08% ownership ratio[176] - The total number of shares remained unchanged at 112,627,120 shares[176] - Shi Huiyong holds 58,800,000 shares, accounting for 52.21% of the total shares, all of which are restricted shares[179] - Shi Yibei holds 8,400,000 shares, accounting for 7.46% of the total shares, all of which are restricted shares[179] - Jincheng Investment holds 8,400,000 shares, accounting for 7.46% of the total shares, all of which are restricted shares[179] - Shi Heyun holds 2,520,000 shares, accounting for 2.24% of the total shares, all of which are restricted shares[179] - Shi Meihua holds 2,520,000 shares, accounting for 2.24% of the total shares, all of which are restricted shares[179] - Shi Hefang holds 2,520,000 shares, accounting for 2.24% of the total shares, all of which are restricted shares[179] - The company repurchased 12,000 restricted shares at 49.13 yuan per share[134] - The company unlocked 10,500 restricted shares for 4 incentive recipients on May 17, 2023, as part of the 2021 restricted stock incentive plan[149] - The total restricted shares at the end of the reporting period were 84,378,972 shares, with 170,676 shares set to be unlocked on July 21, 2023, and 16,500 shares on January 27, 2024[150] Environmental and Social Responsibility - The company has properly disposed of pollutants, with major pollutant emissions meeting standards, and the treatment capacity of major facilities is sufficient to meet pollutant treatment needs[16] - The company is actively exploring ways to reduce resource consumption and increase resource recycling, including replacing high-energy-consuming equipment and using energy-saving LED lighting[17] - The company is committed to environmental protection through water recycling and purchasing energy-efficient equipment[115] - The company has maintained ISO14001 environmental management certification since 2013 and has effective measures for waste treatment[135] - The company is committed to reducing carbon emissions and has implemented relevant measures[136] Research and Development - The company obtained new product certifications, including a CE (IVDR) certification for Class A sterile vacuum blood collection tubes[11] - R&D expenses for the period were RMB 25.5407 million, accounting for 5.57% of revenue, an increase of 0.47 percentage points year-over-year[91] - The company obtained 2 new invention patents, 1 utility model patent, and 1 CE (IVDR) Class A certification during the reporting period[91] - The company completed the MDSAP (Medical Device Single Audit Program) certification, enhancing international market access[92] - R&D expenses decreased by 37.32% to 2.554 billion RMB from 4.074 billion RMB in the same period last year[100] Market and Sales - The company's overseas sales revenue was 227.564 million, accounting for 49.66% of total revenue, with a significant portion settled in USD, exposing the company to exchange rate fluctuation risks[10] - The company's sales model includes domestic distribution, direct sales, and OEM/ODM for international markets, with indirect exports settled in RMB and direct exports settled in USD and EUR[60] - The company has established a stable supply system for major raw materials, signing annual procurement framework contracts with suppliers[59] - The company is one of the larger domestic manufacturers of disposable medical consumables with a comprehensive product line[58] - The global medical device market is expected to reach USD 562.8 billion in 2023, with a compound annual growth rate of 5.6%[79] - The company's main business is the R&D, production, and sales of disposable medical consumables, covering blood collection, medical testing, collection, medical care, and drug packaging materials[82] - The company adopts a "make-to-order" production model for international markets and a combination of "make-to-order" and "stock-based" production for domestic markets[83] - The company has a strong advantage in customized products, with advanced mold R&D and manufacturing capabilities, enabling it to provide cost-effective solutions to international clients[84] - The company has passed ISO13485 quality management system certification and holds 28 domestic Class I and II medical device registrations, with some products approved by the US FDA and EU CE[85] - Blood collection products revenue increased by 23.36% year-over-year to RMB 135.3565 million, accounting for 30.86% of total revenue[95] - Medical testing products revenue decreased by 61.23% year-over-year to RMB 155.1267 million, accounting for 35.37% of total revenue[95] - Pharmaceutical packaging products revenue increased by 56.31% year-over-year to RMB 27.9295 million, accounting for 6.37% of total revenue[95] - Domestic sales decreased by 65.39% to 20.344 billion RMB, accounting for 46.39% of total sales, compared to 58.778 billion RMB and 73.89% in the same period last year[97] - Overseas sales increased by 13.22% to 23.511 billion RMB, accounting for 53.61% of total sales, compared to 20.766 billion RMB and 26.11% in the same period last year[97] - Total revenue decreased by 42.65% to 45.820 billion RMB from 79.896 billion RMB in the same period last year[99] - Operating costs decreased by 32.44% to 31.080 billion RMB from 46.006 billion RMB in the same period last year[99] - The company's products are sold in over 100 countries and regions, including Europe, America, Asia, and Africa[106] - The company has a comprehensive product system with over 5,000 specifications across 6 major categories, covering clinical diagnosis, nursing, scientific research, and pharmaceutical packaging[107] - The company has established a relatively complete quality control system, and no quality-related accidents, disputes, or litigation occurred during the reporting period[108] Corporate Governance and Commitments - The company has disclosed all related-party transactions and committed to conducting unavoidable transactions on fair and reasonable terms[21] - The company's controlling shareholders and actual controllers, Shi Huiyong and Shi Yibei, have committed to repurchasing all newly issued shares and repurchasing their original restricted shares if the prospectus contains false records, misleading statements, or major omissions, as determined by relevant authorities[140] - The company's directors and senior management have pledged to ensure the accuracy and completeness of the prospectus and will bear individual and joint legal responsibilities for any false records, misleading statements, or major omissions[140] - The company's supervisors have committed to minimizing and standardizing related-party transactions, ensuring fair pricing and compliance with relevant regulations[141] - Shareholder Jinchi Investment has pledged to avoid any business activities that compete with the company's main operations, both domestically and internationally[142] - The company's directors, supervisors, and senior management have committed to avoiding any competitive activities with the company's business during their tenure and for six months after resignation[142] - The company has no significant litigation, arbitration, or regulatory penalties involving its directors, supervisors, senior management, controlling shareholders, or actual controllers during the reporting period[144] - The company has no significant asset or equity acquisition or sale transactions involving related parties during the reporting period[146] - The company has no significant contracts, guarantees, or other major matters requiring disclosure during the reporting period[147] - The company has committed to avoiding any form of competition with its main business, both domestically and internationally[169] - The company has pledged to compensate investors if the prospectus contains false statements or omissions that lead to losses[167] - The company has established strict regulations to prevent the misuse of related-party transactions and ensure fair pricing[
拱东医疗:独立董事关于第二届董事会第二十三次会议相关事项的独立意见
2023-08-25 07:37
(下接签字页) 独立董事关于第二届董事会第二十三次会议相关事项的独立意见 我们作为浙江拱东医疗器械股份有限公司(以下简称"公司")的独立董事, 根据《上市公司独立董事规则》《上海证券交易所股票上市规则》《公司章程》 等有关规定,对公司第二届董事会第二十三次会议审议的《关于公司 2023 年半 年度利润分配预案的议案》进行了审阅,发表如下独立意见: 我们认为: 公司 2023 年半年度利润分配预案综合考虑了公司实际经营情况、 财务状况、长远发展、股东合理回报等因素,符合《中华人民共和国公司法》《上 市公司监管指引第 3 号一上市公司现金分红》《公司章程》等相关规定,审议及 表决程序合法合规,不存在损害公司及全体股东,尤其是中小股东利益的情形。 综合以上情况,我们一致同意该项议案。 浙江拱东医疗器械股份有限公司 (本页无正文,为《浙江拱东医疗器械股份有限公司独立董事关于第二届董事 会第二十三次会议相关事项的独立意见》之签字页) 独立董事签名: 王呈斌(签字): 郑 峰(签字): n 王兴斌(签字): 2023 年 8月 25日 ...
拱东医疗:关于召开公司2023年第一次临时股东大会的通知
2023-08-25 07:37
证券代码:605369 证券简称:拱东医疗 公告编号:2023-034 浙江拱东医疗器械股份有限公司 关于召开 2023 年第一次临时股东大会的通知 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。 重要内容提示: 一、 召开会议的基本情况 (一)股东大会类型和届次 2023 年第一次临时股东大会 (二)股东大会召集人:董事会 (三)投票方式:本次股东大会所采用的表决方式是现场投票和网络投票相结 合的方式 (四)现场会议召开的日期、时间和地点 召开的日期时间:2023 年 9 月 12 日 14 点 00 分 召开地点:浙江拱东医疗器械股份有限公司三楼会议室 (五)网络投票的系统、起止日期和投票时间。 网络投票系统:上海证券交易所股东大会网络投票系统 网络投票起止时间:自 2023 年 9 月 12 日 至 2023 年 9 月 12 日 采用上海证券交易所网络投票系统,通过交易系统投票平台的投票时间为股 股东大会召开日期:2023年9月12日 本次股东大会采用的网络投票系统:上海证券交易所股东大会网络投票 系统 东大会召开当日 ...
拱东医疗:2023年半年度利润分配预案公告
2023-08-25 07:35
证券代码:605369 证券简称:拱东医疗 公告编号:2023-033 浙江拱东医疗器械股份有限公司 2023 年半年度利润分配预案公告 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个别及连带责任。 重要内容提示: 每股分配比例:每 10 股派发现金红利 5 元(含税)。 本次利润分配以实施权益分派股权登记日登记的总股本为基数,具体日 期将在权益分派实施公告中明确。 在实施权益分派的股权登记日前公司总股本发生变动的,拟维持每股分 配比例不变,相应调整分配总额。 本次利润分配预案尚需提交公司股东大会审议。 该项议案尚需提交公司股东大会审议。 (二)独立董事意见 公司独立董事发表意见如下:公司 2023 年半年度利润分配预案综合考虑了 公司实际经营情况、财务状况、长远发展、股东合理回报等因素,符合《中华 人民共和国公司法》《上市公司监管指引第 3 号—上市公司现金分红》《公司章 程》等相关规定,审议及表决程序合法合规,不存在损害公司及全体股东,尤 其是中小股东利益的情形。 一、利润分配预案内容 根据浙江拱东医疗器械股份有限公司(以下简称" ...
拱东医疗:第二届董事会第二十三次会议决议公告
2023-08-25 07:35
重要内容提示: 一、董事会会议召开情况 浙江拱东医疗器械股份有限公司(以下简称"公司")第二届董事会第二十 三次会议于 2023 年 8 月 25 日在公司三楼会议室以现场结合通讯表决方式召开。 会议通知已于 2023 年 8 月 14 日通过专人送达或电子邮件的方式发出。本次会议 由董事长施慧勇先生主持,会议应出席董事 7 人,实际出席董事 7 人(其中以通 讯表决方式出席会议的董事 4 人)。公司监事、高级管理人员列席本次会议。本 次会议的召集、召开符合有关法律、行政法规、部门规章、规范性文件和公司章 程的规定,决议内容合法有效。 证券代码:605369 证券简称:拱东医疗 公告编号:2023-031 浙江拱东医疗器械股份有限公司 第二届董事会第二十三次会议决议公告 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。 独立董事已就此发表同意的独立意见,该项议案尚需提交公司股东大会审议。 具体内容详见公司披露于上海证券交易所网站(www.sse.com.cn)的《2023 年半年度利润分配预案公告》(公告编号:2023-033) ...
拱东医疗:第二届监事会第十七次会议决议公告
2023-08-25 07:35
证券代码:605369 证券简称:拱东医疗 公告编号:2023-032 浙江拱东医疗器械股份有限公司 公司监事会及全体监事保证半年度报告内容的真实性、准确性、完整性,不 存在虚假记载、误导性陈述或重大遗漏,并承担个别和连带的法律责任。 具体内容详见公司披露于上海证券交易所网站(www.sse.com.cn)的《公司 2023 年半年度报告》及《公司 2023 年半年度报告摘要》。 (二)审议通过了《关于公司 2023 年半年度利润分配预案的议案》 第二届监事会第十七次会议决议公告 本公司监事会及全体监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。 重要内容提示: 一、监事会会议召开情况 浙江拱东医疗器械股份有限公司(以下简称"公司")第二届监事会第十七 次会议于 2023 年 8 月 25 日在公司三楼会议室以现场表决的方式召开。会议通知 已于 2023 年 8 月 14 日通过专人送达或电子邮件的方式发出。本次会议由监事会 主席张景祥先生主持,会议应出席监事 3 人,实际出席监事 3 人。本次会议的召 集、召开符合有关法律、行政法规、部门规章、 ...
拱东医疗:关于公司产品获得欧盟MDR认证的公告
2023-08-15 07:37
证券代码:605369 证券简称:拱东医疗 公告编号:2023-030 浙江拱东医疗器械股份有限公司 关于公司产品获得欧盟 MDR 认证的公告 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个别及连带责任。 浙江拱东医疗器械股份有限公司(以下简称"公司")于近日收到由欧盟公 告机构TÜV SÜD南德意志集团签发的Medical Device Regulation (EU)2017/745 (简称"MDR")认证证书。现将相关情况公告如下: 一、证书基本情况 证书编号:G10 042464 0037 Rev. 00 分 类:Class IIa 器 械 组 : B030102-APHERESIS PLATELET COLLECTION DEVICES (B030102-单采血小板收集装置) 预期用途:作为静脉血液采集和储存的容器,通过离心法制备和收集富血小 板纤维蛋白(PRF)。 有 效 期:2023-08-10 至 2028-08-09 二、对公司的影响 富血小板纤维蛋白管系公司根据客户需求而开发的新产品,其 MDR 证书的 取得,表明该 ...