Sansure Biotech Inc. (688289.SH) Obtains Medical Device Registration Certificates and EU CE-IVDR Certification

Stock News
2025/11/07

Sansure Biotech Inc. (688289.SH) announced that it has recently secured three product certifications and registrations, including two Class III medical device registration certificates in China and one EU CE-IVDR certification. Norovirus, rotavirus, and enteric adenovirus are common pathogens causing viral diarrhea, known for their high infectivity and widespread prevalence, particularly among children and the elderly. The company's newly launched products—a Norovirus single-test kit and a triple-test kit for Group A Rotavirus/Norovirus/Group F Enteric Adenovirus—will significantly enhance clinical capabilities for rapid identification and precise diagnosis of diarrhea pathogens, providing robust protection for key populations such as children and the elderly in China.

Epstein-Barr virus (EBV) is highly prevalent globally and is not only the primary cause of infectious mononucleosis but also closely linked to post-transplant lymphoproliferative disorder (PTLD) and the development of various cancers, including nasopharyngeal carcinoma, Hodgkin’s lymphoma, and gastric cancer. The EU CE-IVDR certification for the EBV detection reagent further enriches the company's herpesvirus testing product line and demonstrates compliance with stringent international standards in product quality, technical performance, and management systems. This achievement marks a significant milestone in Sansure Biotech's molecular diagnostics strategy and global expansion efforts.

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