格隆汇11月20日丨普门科技(688389.SH)公布，公司获得由TüVSüDAmericaInc.颁发的"医疗器械单一审 核程序"（MedicalDeviceSingleAuditProgram，MDSAP）认证证书。MDSAP是国际医疗器械监管机构论 坛（IMDRF）成员共同发起的项目，旨在医疗器械制造商通过MDSAP认可的审核组织的一次审核，即 可满足不同国家的质量管理体系要求。本次获得MDSAP认证的产品满足巴西、美国监管机构对相关医 疗器械质量管理体系的要求，可以在巴西、美国替代部分审核和常规检查，有助于降低公司相关产品的 审核成本、提升管理效率，对公司未来的海外市场拓展将产生积极影响。 ...

Core Points - The company, Pumen Technology (688389.SH), announced that 26 of its electrochemical luminescence reagent products and hemoglobin chromatography columns have received IVDR CE certification from TÜV SÜD, a European Union notified body [1] - The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR, EU2017/746) replaces the previous In Vitro Diagnostic Medical Devices Directive (IVDD, 98/79/EC) for managing in vitro diagnostic medical devices in the EU market [1] - To date, the company has a total of 53 electrochemical luminescence reagent products that have obtained IVDR CE certification [1]

Core Viewpoint - The company, Pumen Technology (688389.SH), has received IVDR CE certification for 26 electrochemical luminescent reagent products and hemoglobin chromatography columns, indicating compliance with the new EU regulations for in vitro diagnostic medical devices [1] Group 1 - The new EU In Vitro Diagnostic Medical Device Regulation (IVDR, EU2017/746) replaces the previous In Vitro Diagnostic Medical Device Directive (IVDD, 98/79/EC) for managing in vitro diagnostic medical devices in the EU market [1] - The company has achieved a total of 53 electrochemical luminescent reagent products certified under IVDR CE [1]

证券代码：688389 证券简称：普门科技 公告编号：2025-078 深圳普门科技股份有限公司 关于自愿披露公司产品获得IVDR CE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、准确性和完整性依法承担法律责任。 近日，深圳普门科技股份有限公司（以下简称"公司"）的 26 项电化学发 光试剂产品以及血红蛋白层析柱获得欧盟公告机构 TÜV 南德意志集团签发的 IVDR CE 认证。具体情况如下： | 序 | 产品名称 | 分类 | 证书 | 预期用途 | | --- | --- | --- | --- | --- | | 号 | | | 有效期至 | | | 1 | hs-cTnI (eCLIA) 高敏心肌肌钙蛋白 I（hs-cTnI）测定试 | Class C | 2029-06-23 | | | | 剂盒（电化学发光法） | | | | | | Heart-type Fatty Acid Binding Protein (Electrochemiluminescence immunoassay) | | | | | 2 | 心脏型脂肪酸结 ...

Core Viewpoint - The company, Pumen Technology (688389.SH), has received the "Medical Device Single Audit Program" (MDSAP) certification from T V S D America Inc., which enhances its credibility in the medical device market [1] Group 1: Certification Details - The certification covers the design, development, production, and distribution of various medical devices, including negative pressure drainage dressing kits, medical negative pressure suction devices, air wave pressure therapy systems, shock wave therapy devices, and drainage bottles [1] - Additionally, the certification includes the design, development, production, and distribution of in vitro diagnostic medical devices such as electrochemiluminescence analyzers and reagents, hemoglobin analyzers and chromatography columns, glycated hemoglobin analyzers and chromatography columns, and immunofluorescence analyzers [1]

Core Viewpoint - The company, Pumen Technology (688389.SH), has received the "Medical Device Single Audit Program" (MDSAP) certification from TÜV SÜD America Inc., which enhances its credibility in the medical device industry [1] Group 1: Certification Details - The certification covers the design, development, production, and distribution of various medical devices, including negative pressure drainage dressing sets, medical negative pressure suction devices, air wave pressure therapy systems, shock wave therapy devices, and drainage bottles [1] - Additionally, the certification includes in vitro diagnostic medical devices such as electrochemiluminescence analyzers and reagents, hemoglobin analyzers and chromatography columns, glycated hemoglobin analyzers and chromatography columns, and immunofluorescence analyzers [1]

Core Viewpoint - The company has received IVDR CE certification for 26 electrochemical luminescence reagent products and hemoglobin chromatography columns, enhancing its competitiveness in the EU market and other regions recognizing IVDR CE certification [1] Product Certification - The certified products include hs-cTnI (eCLIA), Heart-type Fatty Acid Binding Protein (Electrochemiluminescence immunoassay), and Lipoprotein-Associated Phospholipase A2 (Electrochemiluminescence Immunoassay) [1] - Additionally, the certification covers Multi Control Cardiac Marker composite quality control products [1] Certification Validity - The certification for these products is valid until June 23, 2029, indicating a long-term approval for market access [1]

（文章来源：证券日报） 证券日报网讯普门科技11月18日在互动平台回答投资者提问时表示，未来，公司将继续致力于提升核心 竞争力与盈利能力，我们坚信公司的长期价值终将在资本市场得到合理体现。 ...

Market Overview - The electronic chemicals sector increased by 0.67% on November 17, with Siquan New Materials leading the gains [1] - The Shanghai Composite Index closed at 3972.03, down 0.46%, while the Shenzhen Component Index closed at 13202.0, down 0.11% [1] Stock Performance - Siquan New Materials (301489) closed at 184.89, up 4.89% with a trading volume of 46,100 shares and a transaction value of 849 million [1] - Other notable performers included: - Glinda (603931) at 30.98, up 3.96% with a trading volume of 172,300 shares [1] - Guanghua Technology (002741) at 23.88, up 3.06% with a trading volume of 665,400 shares [1] - National Ceramic Materials (300285) at 25.21, up 2.86% with a trading volume of 417,400 shares [1] Capital Flow - The electronic chemicals sector saw a net inflow of 598 million from institutional investors, while retail investors experienced a net outflow of 624 million [2][3] - Key stocks with significant capital flow included: - Guanghua Technology with a net inflow of 159 million from institutional investors [3] - Siquan New Materials with a net inflow of 124 million from institutional investors [3] - Glinda with a net inflow of 109 million from institutional investors [3]

证券代码：688389 证券简称：普门科技 公告编号：2025-077 深圳普门科技股份有限公司 关于参加2025年度深圳辖区上市公司投资者 网上集体接待日活动的公告 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、准确性和完整性依法承担法律责任。 本次活动将采用网络远程的方式举行，投资者可登录"全景路演"网站 （http://rs.p5w.net），或关注微信公众号：全景财经，或下载全景路演APP，参 与本次互动交流，活动时间为2025年11月20日（周四）14:30-17:00。 届时公司管理层将在线就公司业绩、公司治理、发展战略、经营状况等投资 者关心的问题，与投资者进行沟通与交流，欢迎广大投资者踊跃参与！ 特此公告。 深圳普门科技股份有限公司董事会 2025年11月12日 1 / 1 为进一步加强与投资者的互动交流，深圳普门科技股份有限公司（以下简称 "公司"）将参加由深圳证监局和中证中小投资者服务中心指导、深圳上市公司 协会与深圳市全景网络有限公司联合举办的"2025年度深圳辖区上市公司投资者 网上集体接待日活动"，现将相关事项公告如下： ...