ARNHEM, Netherlands, February 25, 2026 — SINOMED today announced that its controlled subsidiary SINOMED Neurovita Technology Inc’s self-developed GHUNTER® Intracranial Thrombectomy Stent has received EU CE MDR certification. GHUNTER® is the first self-developed product from SINOMED Neurovita Technology Inc to obtain overseas regulatory approval, marking a milestone in the company’s neurointerventional globalization.
Two certificates were issued on February 18, 2026: EU Quality Management System Certificate (2291466TD01) and EU Technical Documentation Assessment Certificate (2291466CE01), both valid until February 1, 2031.
The GHUNTER® stent features full radiopacity design for enhanced visibility, a coiled design ensuring good wall apposition and thrombus entrapment capability, and a combination of large and small mesh openings for improved engagement with various thrombus types. It is available in a comprehensive range of sizes suitable for different vessel diameters.
The device is indicated for the removal of thrombi from intracranial large vessels (internal carotid artery, middle cerebral artery M1/M2 segments, basilar artery, vertebral artery) in patients with ischemic stroke within 24 hours of symptom onset. It is suitable for patients who cannot receive IV t-PA or who have failed IV t-PA therapy.
The GHUNTER® device received Chinese NMPA approval in April 2023. SINOMED Neurovita Technology Inc has established a quality management system compliant with EU MDR requirements, enabling the product to be marketed in regions recognizing EU CE marking.
About SINOMED
SINOMED is a global medical device company engaged in research, development, production, and commercialization of interventional devices. We are focused on developing first-in-class technologies to target unmet clinical needs in the interventional treatment of coronary, neurovascular and structural heart disease. Our mission is to bring the benefits of medical innovation to more patients worldwide, improving both the longevity and quality of their lives.
About SINOMED Neurovita
SINOMED Neurovita is a global medical device company engaged in research, development, production, and commercial distribution of neurointerventional devices. We are focused on developing breakthrough technologies to target unmet clinical needs in the endovascular treatment of intracranial atherosclerotic disease, ischemic stroke, and related neurovascular conditions. Our mission is to expose more patients to the benefits of our medical innovations, increasing patient longevity and quality of life.