Workflow
David Medical(300314)
icon
Search documents
戴维医疗:关于全资子公司申报医疗器械注册获得受理的公告
2024-02-01 07:43
证券代码:300314 证券简称:戴维医疗 公告编号:2024-002 | 序号 | 产品名称 | 注册分类 | | 临床用途 | | --- | --- | --- | --- | --- | | 1 | 一次性使用电动肛肠吻合器 | II | 类 | 该产品适用于选择性切除直肠齿 | | | | | | 状线上粘膜和粘膜下组织,恢复 | | | | | | 直肠下段正常解剖结构,供齿状 | | | | | | 线上黏膜选择性切除用。 | | 2 | 一次性使用电动管型吻合器 | II | 类 | 该产品用于消化道重建手术中组 | | | | | | 织的端端吻合、端侧和侧侧吻合。 | 1、一次性使用电动肛肠吻合器 目前临床使用的肛肠吻合器在设计、生产和临床使用环节已进入 相对成熟的阶段,肛肠吻合器普遍用于选择性切除直肠齿状线上粘膜 和粘膜下组织,恢复直肠下段正常解剖结构,供齿状线上黏膜选择性 切除手术,由于疤痕小、使用安全及操作便捷等性质,在外科手术领 域中应用广泛。 维尔凯迪开发的一次性使用电动肛肠吻合器在原有手动控制吻 合技术基础上升级为电动控制吻合,具有快速、精确、方便等特点的 有源手术器械,能够提 ...
戴维医疗:关于公司及全资子公司通过高新技术企业认定的公告
2023-12-29 07:54
特此公告。 宁波戴维医疗器械股份有限公司 董事会 2023 年 12 月 29 日 证券代码:300314 证券简称:戴维医疗 公告编号:2023-041 宁波戴维医疗器械股份有限公司 关于公司及全资子公司通过高新技术企业认定的公告 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。 宁波戴维医疗器械股份有限公司(以下简称"公司")及全资子公司宁 波维尔凯迪医疗器械有限公司(以下简称"维尔凯迪")收到全国高新技术 企业认定管理工作领导小组办公室公示的《对宁波市认定机构 2023 年认定 报备的第一批高新技术企业进行备案的公告》,公司及维尔凯迪被认定为高 新技术企业,证书编号分别为 GR202333102141 和 GR202333102669,发证日 期为 2023 年 12 月 08 日,有效期三年(即 2023 年至 2025 年)。 本次系公司及维尔凯迪原高新技术企业证书有效期满后进行的重新认 定。根据国家相关规定,公司及维尔凯迪自本次通过高新技术企业认定起连 续三年内(2023 年至 2025 年)可享受国家关于高新技术企业相关优惠政策, 即按 15%税率 ...
戴维医疗:关于全资子公司产品获得医疗器械注册证的公告
2023-12-28 07:44
证券代码:300314 证券简称:戴维医疗 公告编号:2023-040 宁波戴维医疗器械股份有限公司 关于全资子公司产品获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。 宁波戴维医疗器械股份有限公司(以下简称"公司")全资子公司宁 波维尔凯迪医疗器械有限公司(以下简称"维尔凯迪")于近日收到浙江 省药品监督管理局颁发的《医疗器械注册证》,具体如下: 一、医疗器械注册证的具体情况 产品名称:一次性使用包皮切割吻合器 型号、规格:PCS-A-13、PCS-A-15、PCS-A-17、PCS-A-22、PCS-A-26、 PCS-A-30、PCS-A-34、PCS-B-13、PCS-B-15、PCS-B-17、PCS-B-22、PCS-B-26、 PCS-B-30、PCS-B-34、PCS-C-13、PCS-C-15、PCS-C-17、PCS-C-22、PCS-C-26、 PCS-C-30、PCS-C-34 注册证编号:浙械注准20232022068 批准日期:2023年12月22日 有效期至:2028年12月21日 注册分类:Ⅱ类 二、新产 ...
戴维医疗:关于全资子公司申报医疗器械注册获得受理的公告
2023-12-21 08:31
证券代码:300314 证券简称:戴维医疗 公告编号:2023-039 宁波戴维医疗器械股份有限公司 关于全资子公司申报医疗器械注册获得受理的公告 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。 上述医疗器械产品目前所处的审批阶段为注册申请受理,后续所 需的审批流程为技术审评、行政审批、制证。上述品种注册申请受理 对公司近期业绩不会产生影响,审评工作在各阶段所需的时间和结果 均具有一定的不确定性,公司将对上述品种的后续进展情况及时履行 信息披露义务。敬请广大投资者予以关注并注意投资风险。 宁波戴维医疗器械股份有限公司(以下简称"公司")全资子公 司宁波维尔凯迪医疗器械有限公司(以下简称"维尔凯迪")于近日 取得由浙江省药品监督管理局颁发的1项《受理通知书》,受理号为: 械受20234022193。具体情况如下: | 序号 | 产品名称 | 注册分类 | 临床用途 | | --- | --- | --- | --- | | 1 | 一次性使用切口保护套 | II 类 | 适用于内窥镜手术及小 | | | | | 切口手术,扩展切口术 | | | | | 野,保护 ...
戴维医疗(300314) - 戴维医疗调研活动信息
2023-11-21 10:52
Financial Performance - The company achieved a revenue of 459 million CNY in the first three quarters, representing a year-on-year growth of 31.21% [1] - The net profit attributable to shareholders reached 123 million CNY, with a year-on-year increase of 61.70% [1] - The net profit after deducting non-recurring gains and losses was 106 million CNY, showing a year-on-year growth of 72.33% [1] Product Sales Composition - The sales proportion of mid-to-high-end products in the infant care equipment business has steadily increased due to ongoing technological research and product upgrades [1] Market Strategy and Competition - The company is closely monitoring industry dynamics in the stapler market and is enhancing its technological position and competitive advantage through continuous R&D and innovation [2] - There are no current plans for major shareholders to reduce their holdings, with all announcements subject to company disclosures [2] Overseas Business Development - The overseas business is experiencing stable growth, and the company plans to actively expand its international presence based on market developments and its own circumstances [2] Product Development - The subsidiary Weikedi is progressing with the development of a disposable laparoscopic fascia suturing puncture device, with updates to be disclosed in future announcements [2]
戴维医疗(300314) - 2023 Q3 - 季度财报
2023-10-24 16:00
Financial Performance - The company's operating revenue for Q3 2023 was CNY 141,652,800, representing a 0.62% increase compared to CNY 140,779,300 in the same period last year[5]. - Net profit attributable to shareholders for Q3 2023 was CNY 31,018,510, a decrease of 22.84% from CNY 40,081,220 in the previous year[5]. - The net profit after deducting non-recurring gains and losses for Q3 2023 was CNY 23,543,540, down 35.43% from CNY 36,345,810 in the same period last year[5]. - Operating revenue for Q3 2023 reached ¥458.96 million, an increase of 31.21% compared to ¥349.79 million in the previous period[11]. - Net profit for Q3 2023 was ¥122.80 million, reflecting a growth of 61.70% from ¥75.94 million in the same period last year[11]. - Total operating revenue for the current period reached ¥458,961,630.27, a significant increase from ¥349,787,104.41 in the previous period, representing a growth of approximately 31.2%[22]. - Net profit for the current period was ¥122,795,311.05, compared to ¥75,939,978.19 in the previous period, reflecting a growth of approximately 62.0%[23]. Cash Flow - The net cash flow from operating activities for the year-to-date period increased by 178.20% to CNY 69,934,680 compared to CNY 25,138,360 in the previous year[5]. - Cash flow from operating activities increased by 178.20%, amounting to ¥69.93 million, up from ¥25.14 million in the previous period[11]. - Cash flow from operating activities generated a net amount of ¥69,934,687.29, compared to ¥25,138,368.32 in the previous period, showing an increase of approximately 177.8%[24]. - The net cash flow from financing activities was -45,092,548.04 CNY in Q3 2023, compared to -30,531,004.92 CNY in Q3 2022, indicating a decrease of 47.8% year-over-year[25]. - The total cash and cash equivalents at the end of Q3 2023 amounted to 488,634,719.40 CNY, up from 431,386,919.15 CNY at the end of Q3 2022, representing an increase of 13.3%[25]. Assets and Liabilities - The total assets at the end of the reporting period were CNY 1,313,767,009.25, reflecting a 4.69% increase from CNY 1,252,694,543.64 at the beginning of the year[5]. - As of September 30, 2023, the total assets of Ningbo David Medical Instruments Co., Ltd. amounted to CNY 1,313,767,009.25, an increase from CNY 1,254,874,318.44 at the beginning of the year, reflecting a growth of approximately 4.65%[18]. - Total current liabilities decreased to CNY 157,505,195.28 from CNY 176,629,990.11, a reduction of about 10.77%[20]. - The company reported a decrease in total liabilities to CNY 175,110,197.78 from CNY 195,812,818.02, a decline of about 10.15%[20]. - The total liabilities increased from 193,390,231.36 CNY to 195,812,818.02 CNY, with an adjustment of 2,422,586.66 CNY[26]. Shareholder Information - The company’s total number of ordinary shareholders at the end of the reporting period was 15,754[13]. - Major shareholders include Chen Zaihong with 24.69% and Chen Yunqin with 21.12% of the shares[13]. Other Financial Metrics - Investment income turned positive at ¥10.83 million, a significant improvement from a loss of ¥10.55 million in the previous period[11]. - Other income increased by 64.10% to ¥13.98 million, mainly due to an increase in government subsidies[11]. - The company experienced a 37.58% increase in operating costs, which totaled ¥192.65 million, driven by higher sales revenue[11]. - The company's construction in progress rose by 234.31% to ¥27.29 million, primarily due to increased expenditures on the new factory[11]. - The retained earnings increased to CNY 596,905,682.13 from CNY 517,310,371.08, showing a growth of approximately 15.36%[20]. - The company has maintained a stable capital reserve of CNY 175,534,430.38 throughout the reporting period[20]. Adjustments and Audits - The company has not undergone an audit for the Q3 2023 report, as stated in the documentation[31]. - The adjustments made in the financial statements reflect the implementation of new accounting standards starting in 2023[26].
戴维医疗:关于公司部分医疗器械产品完成延续注册的公告
2023-09-07 08:11
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。 宁波戴维医疗器械股份有限公司(以下简称"公司")于近日取得 由浙江省药品监督管理局颁发的1项《医疗器械注册证》,公司产品婴儿 光疗防护眼罩完成了延续注册,具体如下: | 序号 | 产品名称 | 注册证编号 | 注册证有效期至 | 注册分类 | 用途 | 原注册证编号 | | --- | --- | --- | --- | --- | --- | --- | | | | 浙械注准 | | | 产品为接受黄 | | | | 婴儿光疗 | | | | 疸光照治疗的 | | | 1 | | 2019214004 | 2029.02.11 | Ⅱ类 | 婴儿提供眼睛 | __ | | | 防护眼罩 | | | | | | | | | 2 | | | 防护。 | | 证券代码:300314 证券简称:戴维医疗 公告编号:2023-036 本次延续注册的完成,使得公司可以继续生产和销售婴儿光疗防护 眼罩,对公司未来经营将产生积极影响。上述产品的实际销售情况取决 于未来市场推广效果,公司目前尚无法预测其对公司未来业绩的影响, 敬 ...
戴维医疗:关于全资子公司产品获得医疗器械注册证的公告
2023-09-01 07:49
证券代码:300314 证券简称:戴维医疗 公告编号:2023-035 宁波戴维医疗器械股份有限公司 关于全资子公司产品获得医疗器械注册证的公告 注册证编号:国械注准20233011247 批准日期:2023年08月29日 有效期至:2028年08月28日 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。 宁波戴维医疗器械股份有限公司(以下简称"公司")全资子公司宁 波维尔凯迪医疗器械有限公司(以下简称"维尔凯迪")于近日收到国家 药品监督管理局颁发的《医疗器械注册证》,具体如下: 一、医疗器械注册证的具体情况 产品名称:一次性使用电动腔镜用直线型切割吻合器 型号、规格:器身型号规格:VDCM46、VDSM46、VDLM46、VDCM60、VDSM60、 VDLM60;组件型号规格:VDAR46M、VDAR46W、VDAR46B、VDAR46Y、VDAR46G、 VDAR60M、VDAR60W、VDAR60B、VDAR60Y、VDAR60G、VDAR60H、VTAR46M、VTAR46W、 VTAR46B、VTAR46Y、VTAR46G、VTAR60M、VTAR ...
戴维医疗(300314) - 2023 Q2 - 季度财报
2023-08-21 16:00
Financial Performance - The company reported a revenue of RMB 500 million for the first half of 2023, representing a year-on-year increase of 15%[20]. - The net profit attributable to shareholders was RMB 80 million, up 10% compared to the same period last year[20]. - The management has set a revenue target of RMB 1.1 billion for the full year 2023, reflecting a growth rate of 12%[20]. - The company's operating revenue for the first half of 2023 was CNY 317,308,737.59, representing a 51.82% increase compared to CNY 209,007,798.26 in the same period last year[26]. - Net profit attributable to shareholders was CNY 91,776,799.20, a significant increase of 156.79% from CNY 35,916,773.06 in the previous year[26]. - The net profit after deducting non-recurring gains and losses was CNY 82,156,434.51, up 230.33% from CNY 25,047,771.80 in the same period last year[26]. - The net cash flow from operating activities reached CNY 39,851,190.29, marking a 585.05% increase from CNY 5,817,306.68 in the previous year[26]. - The gross margin for the first half of 2023 improved to 45%, up from 40% in the same period last year, reflecting better cost management and pricing strategies[63]. - The company reported a significant increase in revenue, achieving a total of 1.5 billion RMB for the first half of 2023, representing a year-over-year growth of 20%[63]. - The company has set a revenue guidance of 7 billion CNY for the full year 2023, indicating a projected growth of 15%[91]. Research and Development - The company plans to invest RMB 50 million in R&D for new medical devices in the upcoming year[20]. - The company has been focusing on the development of infant care equipment and surgical staplers, with a strong emphasis on R&D and market expansion[34]. - The research and development strategy focuses on modular and series product improvements, utilizing advanced engineering techniques to shorten development cycles[38]. - R&D expenses amounted to 17.11 million yuan, an increase of 3.13% year-on-year, constituting 5.39% of total revenue[52]. - The company has obtained 3 new authorized patents during the reporting period, bringing the total to 230 valid patents[54]. - The company is committed to enhancing its core competitiveness through continuous innovation and R&D investment[52]. - The company is actively developing new products and technologies to enhance its market position and address clinical needs in pediatric care[56]. - The company is focusing on the development of a resuscitation system that includes positive pressure ventilation and negative pressure suction for patients weighing up to 10kg[61]. - The company is enhancing its research and development efforts to support the launch of new medical devices in the coming years[62]. Market Expansion - User data indicates a 20% increase in the number of active users of the company's medical devices[20]. - The company has expanded its market presence in Southeast Asia, achieving a 25% growth in sales in that region[20]. - The company aims to launch two new products by the end of 2023, targeting a market share increase of 5%[20]. - The company is expanding its market presence in Southeast Asia, targeting a 30% increase in market share by the end of 2024[63]. - The company is focusing on market expansion through the introduction of new medical devices tailored for neonatal intensive care units[61]. - The company has developed over 40 international agents, with product sales reaching more than 100 countries across Asia, Africa, Europe, and South America, showcasing its global market expansion[66]. Product Development - The company achieved a total revenue of CNY 317.31 million in the first half of 2023, representing a year-on-year growth of 51.82%[39]. - The company is focusing on product iteration and new product development to drive performance improvement[50]. - The company is enhancing the performance of its infant incubators, achieving a significant improvement in humidity rate and reaching international leading standards[56]. - The company is actively pursuing regulatory approvals for its new products, with several expected to be registered by 2028[61]. - The company is committed to continuous innovation in neonatal care technology, with several products in the pipeline for regulatory approval[61]. - The company is expanding its product line to include advanced features for neonatal care, reflecting a strategic focus on market needs[60]. Financial Strategy - No cash dividends or stock bonuses will be distributed to shareholders for this period[4]. - The company has established a strong brand presence, being one of the first five enterprises in the domestic medical device industry to pass ISO9000 certification, enhancing its market credibility[66]. - The company has maintained a consistent dividend policy, with no changes to the dividend payout ratio reported[99]. - The company is committed to compliance with regulatory requirements for its operations and investments, ensuring sustainable growth[104]. - The company is implementing flexible procurement strategies to mitigate risks associated with raw material price fluctuations[111]. Risks and Challenges - The company is facing potential risks related to regulatory changes in the medical device industry, which may impact future operations[20]. - The company is at risk of declining newborn birth rates affecting its infant care equipment business, which could lead to decreased demand and revenue[109]. - The company is monitoring the impact of centralized procurement policies on product pricing, which could lead to reduced profit margins[110]. - The company is facing risks from intensified market competition, particularly from international companies with significant market shares in higher-tier hospitals[107]. Corporate Governance - The company has maintained high product quality standards and emphasizes customer rights protection through good after-sales service[125]. - The company emphasizes investor rights protection and has established regulations to ensure compliance with relevant laws and regulations[124]. - The company has not engaged in any non-operating fund occupation by controlling shareholders or related parties during the reporting period[130]. - The company reported a participation rate of 66.88% in the 2022 annual general meeting held on April 21, 2023[117]. - There were no changes in the board of directors, supervisors, or senior management during the reporting period[118].
戴维医疗:2023年半年度非经营性资金占用及其他关联资金往来情况汇总表
2023-08-21 08:37
编制单位:宁波戴维医疗器械股份有限公司 单位:万元 | | 资金占用 | 占用方与上 | 上市公司核算 | 2023 年期初 | 2023 年 占用累计发生 | 1-6 月 | 2023 年 1-6 月 | 2023年1-6月 | 2023年6月末 | 占用形 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 非经营性资金占用 | 方名称 | 市公司的关 | 的会计科目 | 占用资金余 | 金额(不含利 | | 占用资金的利 | 偿还累计发 | 占用资金余 | 成原因 | 占用性质 | | | | 联关系 | | 额 | | | 息(如有) | 生金额 | 额 | | | | | | | | | 息) | | | | | | | | 控股股东、实际控制人及 | | | | | | | | | | | 非经营性占用 | | 其附属企业 | | | | | | | | | | | 非经营性占用 | | 小计 | - | - | - | | | | | | | | - | | 前控股股东、实际控制人 | | ...