华东医药(000963.SZ)子公司医疗器械获得欧盟MDR CE认证

智通财经
Aug 09

智通财经APP讯,华东医药(000963.SZ)发布公告,近日,公司英国全资子公司Sinclair Pharma Limited(简称“Sinclair”)旗下一款全新专利成分的注射用羧甲基壳聚糖溶液KIO015获得欧盟MDR CE认证,取得欧盟市场上市准入资格,系全球首款且目前唯一一款创新型非动物源性壳聚糖医美注射产品。

KIO015(商品名:Kytogen ® Defend)产品获得欧盟MDR CE认证,表明该产品符合欧盟市场上市相关要求,具备欧盟市场准入资质,可在欧盟及相关海外市场开展销售。该事项不会对公司当前财务状况和经营成果产生重大影响,对公司未来业绩提升存在一定积极作用。该产品已取得欧盟MDR CE认证,尚未取得国内医疗器械注册证,目前亦未实际形成销售收入。

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