Recently, two original products developed by AccuMedical—the Lattice® Flow Diverter and the Grism® Stent Retriever—officially obtained EU MDR CE Mark certification. This signifies that the Company's solutions for hemorrhagic stroke and ischemic stroke have simultaneously gained access to the European Union market, representing a milestone of great significance for its international development.
The European Union Medical Device Regulation (EU MDR 2017/745) is one of the world's most stringent regulatory frameworks governing medical devices. The simultaneous certification of these two products fully demonstrates that AccuMedical's product design, clinical value, and quality management system comply with the regulatory requirements of the European Union, and that its innovation capabilities have been recognized by internationally authoritative regulatory authorities. At the same time, the value of CE certification extends far beyond access to the European market alone——Through cross-border regulatory recognition mechanisms, local registration procedures in multiple regions, including Southeast Asia, the Middle East, Africa, and Latin America, can be significantly simplified, substantially improving overseas market access efficiency and providing strong momentum for the Company's global commercialization.
The certified products include:Lattice® Flow Diverter, which is primarily indicated for the treatment of intracranial aneurysms. Incorporating AccuMedical's original mechanical balloon delivery system and MIROR surface modification technology, the product was approved for marketing through the NMPA Innovative Medical Device Special Review Procedure (Green Channel) in October 2022. It subsequently received regulatory approval in Vietnam in 2025 and Indonesia in 2026. Grism® Stent Retriever, which is indicated for the treatment of acute ischemic stroke. Its unique distal closed no-tip design effectively prevents clot escape, improves the first-pass recanalization rate, and helps secure valuable treatment time for patients. The product was approved for marketing by the NMPA in 2025. Together, these two products respectively address the therapeutic areas of hemorrhagic stroke and ischemic stroke, further strengthening AccuMedical's foundation for global development while providing high-quality China Solutions for patients worldwide.