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普门科技(688389) - 深圳普门科技股份有限公司关于自愿披露取得医疗器械注册证的公告
2026-01-05 09:15
证券代码:688389 证券简称:普门科技 公告编号:2026-002 本次取得注册证的产品为复合质控品,以样本测量程序测定质控品,将测定 结果进行统计分析或与参考值(参考范围)比较,判断结果是否满足要求,以此 确保公司电化学发光检测系统的安全、有效。 截至本公告披露日,公司及控股子公司已取得 107 个电化学发光配套检测试 剂注册证。上述产品注册证的获得,进一步丰富和完善了公司在体外诊断领域的 产品品种,有利于进一步提升公司在免疫诊断领域的市场竞争力,对公司未来的 经营将产生积极影响。 1 / 2 产品名称 注册 分类 注册证 编号 注册证 有效期至 预期用途 肿瘤标志物 质控品 III 类 国械注准 20253402676 2030 年 12 月 28 日 本质控品与本公司试剂盒配合使用,用于 总前列腺特异性抗原(tPSA)、游离前列 腺特异性抗原(fPSA)、甲胎蛋白(AFP)、 铁蛋白(Ferritin)项目检测时的质量控制; 与重庆普门创生物技术有限公司试剂盒 配合使用,用于癌抗原 125(CA125)、 癌抗原 15-3(CA15-3)、糖类抗原 19-9 (CA19-9)、癌抗原 72-4(CA ...
普门科技:“肿瘤标志物质控品”产品取得注册证
Mei Ri Jing Ji Xin Wen· 2026-01-05 09:15
Group 1 - Company Pumen Technology has recently received a Medical Device Registration Certificate from the National Medical Products Administration of China for its product named "Tumor Marker Quality Control Product" [1] Group 2 - The product is expected to enhance the company's portfolio in the medical device sector, particularly in oncology diagnostics [1] - The announcement reflects the company's ongoing commitment to innovation and compliance with regulatory standards in the healthcare industry [1]
电子化学品板块1月5日涨3.54%,上海新阳领涨,主力资金净流入2.52亿元
Zheng Xing Xing Ye Ri Bao· 2026-01-05 08:59
Group 1 - The electronic chemicals sector increased by 3.54% on January 5, with Shanghai Xinyang leading the gains [1] - The Shanghai Composite Index closed at 4023.42, up 1.38%, while the Shenzhen Component Index closed at 13828.63, up 2.24% [1] - Key stocks in the electronic chemicals sector showed significant price increases, with Shanghai Xinyang rising by 11.70% to a closing price of 71.22 [1] Group 2 - The electronic chemicals sector saw a net inflow of 252 million yuan from institutional investors, while retail investors contributed a net inflow of 39.33 million yuan [2] - Major stocks like Nanda Optoelectronics experienced a net inflow of 142.16 million yuan from institutional investors, despite a net outflow from retail investors [3] - The overall trading volume and turnover in the electronic chemicals sector indicated active market participation, with notable transactions in stocks like Shanghai Xinyang and Nanda Optoelectronics [1][2][3]
普门科技:取得肿瘤标志物质控品医疗器械注册证
Xin Lang Cai Jing· 2026-01-05 08:57
Core Viewpoint - The company has received a medical device registration certificate for tumor marker quality control products from the National Medical Products Administration, which enhances its competitiveness in the immunodiagnostic market [1] Group 1: Regulatory Approval - The company announced the receipt of the registration certificate for tumor marker quality control products, with the registration number 20253402676, valid until December 28, 2030 [1] - This certificate is intended for quality control during relevant project testing [1] Group 2: Product Portfolio and Market Impact - The company and its subsidiaries have obtained a total of 107 registration certificates for electrochemical luminescence detection reagents [1] - The new registration enriches and improves the variety of the company's in vitro diagnostic products, positively impacting its operations [1] - However, the sales situation of these products remains difficult to predict [1]
12月26日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-26 10:18
Group 1 - Zhuolang Intelligent's subsidiary plans to increase capital by 900 million yuan to its wholly-owned subsidiary in Xinjiang [1] - Zhenhua Heavy Industry signed a contract worth 1.149 billion yuan with Guangzhou Salvage Bureau for a deep-water crane ship construction project [2] - Ugreen Technology intends to issue H-shares and apply for listing on the Hong Kong Stock Exchange to enhance its global strategy [3] Group 2 - Guangsheng Nonferrous Metals will change its stock name to Zhongxi Rare Metals starting December 31, 2025 [4] - China Electric Research proposed a cash dividend of 2.5 yuan per 10 shares for the first three quarters of 2025 [5] - Chaoyan Co. is establishing a fund with professional investment institutions, aiming to raise 1 billion yuan [6] Group 3 - Silk Road Vision's subsidiary plans to sell 8.5% of Ruijun Technology for 52.7 million yuan [7] - Longgao Co.'s actual controller is transferring 4.37% of the investment development group's equity for 398 million yuan [8] - Weiteou signed a strategic cooperation agreement with Huaruixin Energy to develop new materials and applications [9][10] Group 4 - Annuoqi decided to terminate the investment in a 50,000-ton dye intermediate project due to market changes, with a total investment of 421 million yuan [12] - Akoli's subsidiary has entered trial production for a project with an annual capacity of 20,000 tons of polyether amine [13] - Ningbo Construction's subsidiary signed a construction contract worth 451 million yuan for a comprehensive utility tunnel project [14] Group 5 - Zhejiang Rongtai and Weichuang Electric plan to establish a joint venture in Thailand for R&D and production of mechatronic components [15] - Jiuzhoutong's subsidiary received a drug registration certificate for isopropazine injection [16] - Huaqin Technology's subsidiary signed a daily operation contract worth 392 million yuan [17] Group 6 - ST Meichen completed the sale of 100% equity in Hainan Meichen Ecological Development Co., Ltd. [18] - Pulite's LCP film products have begun mass production for a leading customer in the consumer electronics industry [19][20] - Nanjing Public Utility's major shareholder transferred 7.61% of the company's shares for 300 million yuan [21] Group 7 - Solar Energy terminated the investment in a 150 MW distributed photovoltaic project due to increased investment risks [22] - Yuntian Lifa won a 122 million yuan project for AI development in Longgang [23] - Changchun High-tech's subsidiary received acceptance for a clinical trial application for GenSci141 ointment [24] Group 8 - Changfei Optical Fiber's major shareholder completed a share reduction plan, selling 1.1 million shares for approximately 104.5 million yuan [25] - Sandam Membrane plans to apply for a comprehensive credit limit of up to 100 million yuan for 2026 [26] - Aisecurity received a government subsidy of 3.4611 million yuan [27] Group 9 - Stone Technology's H-share issuance has received approval from the China Securities Regulatory Commission [28] - Hongxing Development's subsidiary plans to suspend production to comply with national hazardous chemical relocation policies [29] - Guodian Nanzi's vice president and chief engineer resigned [30] Group 10 - Jianghe Group's subsidiary won a bid for a city renovation project in Haikou worth approximately 112 million yuan [31] - Gaotie Electric's subsidiary won a bid for a railway project worth 59.0317 million yuan [32] - Huicheng Co. plans to introduce a new partner to its major shareholder [33] Group 11 - Pumen Technology's folic acid testing kit received a medical device registration certificate [34] - Hai Xin Co.'s vitamin B6 injection passed the consistency evaluation for generic drugs [35] - Taiji Group's shareholder plans to merge with its subsidiary [36] Group 12 - Shengyi Electronics adjusted the maximum repurchase price to no more than 144.36 yuan per share [37]
普门科技(688389) - 深圳普门科技股份有限公司关于自愿披露取得医疗器械注册证的公告
2025-12-26 08:00
证券代码:688389 证券简称:普门科技 公告编号:2025-087 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、准确性和完整性依法承担法律责任。 深圳普门科技股份有限公司(以下简称"公司")于近期收到了1个广东省 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)》, 具体情况如下: 二、对公司的影响 叶酸(Folate),也称为维生素 B9,是一种水溶性 B 族维生素。叶酸在体内 以四氢叶酸(THF)的形式作为辅酶参与多种关键代谢反应,包括 DNA 和 RNA 的合成、氨基酸代谢、血红蛋白的合成以及细胞分裂和增殖等,是人体造血必需 的营养物质之一。叶酸缺乏可引起营养性和巨幼红细胞性贫血、生理功能低下、 胃肠功能紊乱、智力退化以及神经管畸形婴儿的发生。巨幼红细胞性贫血几乎都 是由缺乏叶酸或维生素 B12 之一引起的。 本次取得注册证的叶酸测定试剂盒(电化学发光法),为公司新一代产品, 采用夹心化学发光免疫分析法,进一步提高了试剂的灵敏度、精密度等性能,将 有助于提升公司在贫血检测领域的市场竞争力。 截至本公告披露日,公司及控股子公司 ...
普门科技:公司叶酸测定试剂盒获得医疗器械注册证
Xin Lang Cai Jing· 2025-12-26 07:55
Core Viewpoint - The company has received a medical device registration certificate for its new generation folic acid testing kit, which enhances its competitiveness in the anemia detection market [1] Group 1: Product Development - The company announced the receipt of a registration certificate from the Guangdong Provincial Drug Administration for the folic acid testing kit, classified as a Class II medical device [1] - The product is designed for the quantitative measurement of folic acid levels in human serum or plasma samples, aiding in the diagnosis of megaloblastic anemia [1] - The new testing kit utilizes a sandwich chemiluminescence immunoassay method, improving sensitivity and precision [1] Group 2: Market Position - The company and its subsidiaries have obtained 106 registration certificates for chemiluminescence detection reagents, enhancing the testing menu for its chemiluminescence project [1] - This expansion is expected to strengthen the company's market competitiveness in the immunodiagnostics field [1] Group 3: Future Outlook - The actual sales performance of the product post-launch will depend on future market promotion efforts, and the specific impact on the company's future performance remains unpredictable [1]
普门科技:取得叶酸测定试剂盒医疗器械注册证
Xin Lang Cai Jing· 2025-12-26 07:39
Core Viewpoint - The company has received a medical device registration certificate for its new product, a folic acid assay kit, which enhances its market competitiveness in the anemia detection field [1] Group 1: Product Development - The company has obtained the registration certificate from the Guangdong Provincial Drug Administration for the folic acid assay kit, classified as a Class II medical device, with a registration number valid until December 18, 2030 [1] - The folic acid assay kit is designed for the quantitative measurement of folic acid levels in human serum or plasma, aiding in the diagnosis of megaloblastic anemia [1] - This new generation product utilizes a sandwich chemiluminescent immunoassay method, improving the sensitivity and precision of the assay [1] Group 2: Market Position - The company and its subsidiaries have secured a total of 106 registration certificates for chemiluminescent assay kits, further enriching its testing menu in the immunodiagnostic field [1] - The advancements in product offerings are expected to enhance the company's competitiveness in the immunodiagnostic market [1] Group 3: Sales and Market Impact - The actual sales performance of the newly launched product will depend on future market promotion efforts, and the specific impact on the company's future performance remains unpredictable [1]
普门科技:选举职工代表董事
Zheng Quan Ri Bao Wang· 2025-12-23 14:15
证券日报网讯 12月23日,普门科技发布公告称,公司于2025年12月23日召开职工代表大会,选举刘敏 女士担任公司第三届董事会职工代表董事。 ...
普门科技:截至2025年9月30日普通股股东总数为11859户
Zheng Quan Ri Bao· 2025-12-23 12:12
(文章来源:证券日报) 证券日报网讯 12月23日,普门科技在互动平台回答投资者提问时表示,截至2025年9月30日,公司普通 股股东总数为11859户。 ...