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。 三、风险提示 证券代码：688389 证券简称：普门科技 公告编号：2025-079 深圳普门科技股份有限公司 关于自愿披露获得MDSAP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"）获得由 TÜV SÜD America Inc.颁发的"医疗器械单一审核程序"（Medical Device Single Audit Program，MDSAP）认证证书。具体情况如下： 二、对公司的影响 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。 2 / 2 1 / 2 一、MDSAP 认证证书的具体情况 证书编号 QS6 0 ...

Core Viewpoint - Pumen Technology (688389.SH) has received IVDRCE certification from TüV Süd, enabling its 26 electrochemical luminescent reagent products and hemoglobin chromatography columns to enter the EU market, enhancing its competitiveness in the in vitro diagnostic sector [1] Group 1 - The IVDRCE certification is a requirement for entering the EU market under the EU In Vitro Diagnostic Medical Devices Regulation [1] - The certification is expected to positively impact the company's future operations and market presence [1] - The products certified will also be recognized in other regions that accept IVDRCE certification, broadening the company's market opportunities [1]

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。 ...