赛诺医疗：COMETIU支架国内注册未获批，海外推进中

Core Viewpoint - The domestic registration application for the self-expanding intracranial drug-coated stent system COMET I U by Sino Medical has not been approved by the National Medical Products Administration, but the global market approval process will continue [1] Group 1: Product Registration Status - Sino Medical's subsidiary, Sino Shenchang, did not receive approval for the domestic registration of the COMET I U product [1] - The product has passed the EU MDR on-site quality system audit and is in the final stage of technical review [1] - The product has also received breakthrough medical device designation from the US FDA [1] Group 2: Impact on Operations - The company will continue to advance the product's approval process in multiple countries and regions globally [1] - The lack of domestic registration approval is not expected to have a short-term impact on the company's production and operations [1]