智通财经APP讯，赛诺医疗(688108.SH)发布公告，公司控股子公司赛诺神畅医疗科技有限公司(以下简称“赛诺神畅”)于2024年向欧盟公告机构递交了公司Ghunter颅内取栓支架按照欧盟医疗器械法规Medical Devices Regulation(EU)2017/745(简称“MDR”)注册认证的申报资料。赛诺神畅于近日收到欧盟公告机构通知，Ghunter颅内取栓支架获得按照欧盟MDR法规签发的欧盟CE MDR认证。
本次Ghunter颅内取栓支架产品获得欧盟CE MDR认证，是子公司赛诺神畅自主研发产品首次在海外获得注册认证，意味着赛诺神畅已经建立了符合欧盟MDR法规要求的质量管理体系，生产的颅内取栓支架可满足欧盟医疗器械法规的要求，具备欧盟市场最新的准入条件，且可以在认可欧盟医疗器械法规的区域范围内进行销售。本次获批将对公司产品在相应市场的推广和销售起到积极的促进作用，有助于进一步提高公司产品的市场竞争力，对公司未来经营将产生积极影响。
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