SINOMED: The domestic registration of the subsidiary's product COMETIU stent has not been approved
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SINOMED's subsidiary, SINOMED Shenchang Medical Technology Co., Ltd., has not received approval from the National Medical Products Administration for the COMETIU stent registration application. The product applied for EU MDR certification from DEKRA Certification B.V. in 2024 and has passed the on-site audit, currently in the technical review stage. At the same time, the COMETIU stent received breakthrough medical device designation from the US FDA in 2025, becoming the world's first product for the treatment of intracranial atherosclerotic stenosis
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