格隆汇12月1日丨新产业(300832.SZ)公布，公司乙型肝炎病毒核心抗体检测试剂盒（磁微粒化学发光 法）获得了由欧盟公告机构-TÜV南德意志集团签发的IVDR CE最高风险等级Class D认证证书。新的欧 盟体外诊断医疗器械法规（IVDR,EU2017/746）替代原欧盟体外诊断医疗器械指令（IVDD,98/79/EC） 对欧盟市场的体外诊断医疗器械进行管理。截至目前，公司累计212项化学发光试剂产品、67项生化试 剂产品获得IVDRCE认证。 ...

Group 1 - Company has received the IVDR CE certification for its HIV reagent, marking the successful certification of its entire series of eight preoperative chemiluminescent detection reagents, including HIV, hepatitis B, hepatitis C, and syphilis [1][2] - A total of 229 products have now obtained IVDR CE certification, which allows them to enter the EU market and regions that recognize CE certification, positively impacting the company's business promotion in these areas [1][2] Group 2 - The company announced the results of the second vesting period of its 2023 restricted stock incentive plan, with 961,500 shares set to be listed on December 3, 2025 [3][4] - The decision-making process for the stock vesting involved multiple board meetings and independent opinions, ensuring compliance with regulations [4][5][6] Group 3 - The company has completed the registration of shares for the second vesting period, with a total of 59 individuals participating in this vesting [8][10] - The total capital after the vesting will be approximately RMB 571,388,300, with the new shares accounting for about 0.17% of the total share capital, which is not expected to significantly impact the company's financial results [11] Group 4 - The company has obtained a medical device registration certificate for the anti-gp210 antibody, which is significant for diagnosing primary biliary cholangitis (PBC) [13][14] - The registration of this medical device is expected to enhance the company's product line in the fields of liver and kidney disease detection [15]

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]

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]

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]

Core Viewpoint - Shenzhen Aihuilong Biotechnology Co., Ltd. has received the IVDR CE certification for its products, which allows them to enter the EU market, positively impacting business promotion in the region [1]. Group 1: Certification Details - The company has obtained the highest risk level Class D certification under the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR, EU 2017/746), replacing the previous directive (IVDD, 98/79/EC) [1]. - A total of 226 products have received IVDR CE certification to date, indicating the company's compliance with the new regulatory requirements [1]. Group 2: Market Impact - The certification provides necessary conditions for the company's products to enter the EU market and regions that recognize CE certification, which is expected to have a positive impact on business promotion [1]. - However, the company cannot predict the specific sales performance of these products due to market factors, emphasizing the need for rational investment by stakeholders [1].

Core Points - The company has received the highest risk level Class D certification from BSI Group The Netherlands B.V. for its products under the IVDR CE marking [1] - A total of 226 products have now obtained IVDR CE certification, allowing them to enter the EU market [1] - The certification will positively impact the company's business promotion in the EU and CE-recognized regions, although the specific sales performance remains uncertain due to market factors [1]

Core Points - Aihua Long (688575.SH) has received the highest risk level Class D certification from BSI Group The Netherlands B.V. under the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR, EU 2017/746), which replaces the previous directive (IVDD, 98/79/EC) for managing in vitro diagnostic medical devices in the EU market [1] Product Certification Details - Product Name: iFlash-HBsAg Hepatitis B Surface Antigen - Certificate Number: IVDR 781230 - Valid Until: September 1, 2030 - Clinical Use: Quantitative detection of Hepatitis B surface antigen in human serum or plasma, assisting in diagnosis [2] - Product Name: iFlash-Anti-HBs Hepatitis B Surface Antibody - Certificate Number: IVDR 781231 - Valid Until: September 1, 2030 - Clinical Use: Quantitative detection of Hepatitis B surface antibody in human serum or plasma, assisting in monitoring vaccination effects or recovery progress of infected individuals [2]

Group 1 - Shenzhen Pumen Technology Co., Ltd. has recently obtained IVDR CE certification for seven electrochemiluminescence reagent products from T?V S?D Group, which is a significant achievement for the company [1] - The certified products include various prostate-specific antigen kits and other diagnostic assays, which are intended for cancer screening, diagnosis, and monitoring [1] - With the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR), the company has now a total of 27 electrochemiluminescence reagent products certified, enhancing its competitiveness in the EU market [1] Group 2 - The IVDR CE certification allows the company’s products to enter the EU market, which is expected to positively impact the company's future operations [1]