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]

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]

Core Insights - The company, Pumen Technology, has recently announced that seven of its electrochemical luminescent reagent products have received IVDR CE certification from the EU Notified Body T V Süddeutsche Gruppe [1] Group 1 - The certification indicates compliance with European regulations for in vitro diagnostic medical devices, enhancing the company's marketability in the EU [1] - This achievement may open new opportunities for the company in the European market, potentially increasing sales and market share [1] - The certification process reflects the company's commitment to quality and regulatory standards in the healthcare industry [1]

Core Viewpoint - The company has received IVDR CE certification from T V South German Group for 13 electrochemical luminescence reagent products, enhancing its competitiveness in the EU market [1] Group 1: Certification Details - The certified products include assays for anti-thyroglobulin antibody, C-peptide, total triiodothyronine, total thyroxine, thyroxine-binding globulin, free triiodothyronine, free thyroxine, estradiol, follicle-stimulating hormone, luteinizing hormone, prolactin, and testosterone [1] - These products are classified as Class B and have a validity period until June 23, 2029 [1] - The company has a total of 20 electrochemical luminescence reagent products that have obtained IVDR CE certification to date [1] Group 2: Market Impact - The new IVDR regulations replace the previous IVDD directive, governing in vitro diagnostic medical devices in the EU market [1] - The certification allows the company’s products to enter the EU market, which is expected to positively impact the company's future operations [1]