華仁藥業(300110.SZ)子公司華仁醫療取得兩項醫療器械註冊證
格隆匯4月17日丨華仁藥業(300110.SZ)公佈，近日，公司全資子公司青島華仁醫療用品有限公司(“華仁醫療”)收到山東省藥品監督管理局核准簽發的《醫療器械註冊證》。
醫用外科口罩註冊證內容為：產品名稱：醫用外科口罩；型號、規格：HRKWAS、HRKWAM、HRKWAL；結構及組成：由非織造布、熔噴過濾布、鼻夾、口罩帶組成。包含兩層非織造布、一層熔噴過濾布，鼻夾由PVC材料包裹鍍鋅鐵絲構成，口罩帶由彈性錦綸加氨綸組成，產品以非無菌形式提供。適用範圍：供臨牀醫務人員佩帶，覆蓋住使用者的口、鼻及下頜，為防止病原體微生物、體液、顆粒物等的直接透過提供物理屏障。有效期至：2021年4月15日。備註：疫情急需，應急審評審批，核發註冊證後三個月內須儘快補充生物學試驗報告；本註冊證有效期滿後，須重新申請產品註冊。
一次性使用醫用口罩註冊證內容為：產品名稱：一次性使用醫用口罩；型號、規格：HRKYAS、HRKYAM、HRKYAL；結構及組成：由無紡布、熔噴過濾布、鼻樑條、口罩帶組成，包含兩層無紡布、一層熔噴過濾布，鼻夾由PVC材料包裹鍍鋅鐵絲構成，口罩帶由彈性錦綸加氨綸組成，產品以非無菌形式提供。適用範圍：供臨牀各類人員在非有創操作過程中佩帶，覆蓋住使用者的口、鼻及下頜，為防止病原體微生物、顆粒物等的直接透過提供一定的物理屏障。有效期至：2021年4月15日。備註：疫情急需，應急審評審批，核發註冊證後三個月內須儘快補充生物學試驗報告；本註冊證有效期滿後，須重新申請產品註冊。
子公司華仁醫療取得以上醫療器械註冊證後，將具備生產銷售醫用外科口罩產品和一次性使用醫用口罩產品的資質，進一步豐富口罩類產品的種類，公司將積極推進醫用及民用口罩防護用品的生產及銷售，預計對公司產生積極影響。
此次華仁醫療取得兩項醫療器械註冊證，註冊證有效期為一年，屬疫情應急審評審批，註冊證有效期屆滿後，須重新申請產品註冊，如不能獲得新的許可批准，存在不能繼續生產的風險。
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