戴維醫療(300314.SZ)：醫療器械註冊證變更
格隆匯 12 月 22日丨戴維醫療(300314.SZ)公佈，公司於近日取得由國家藥品監督管理局頒發的2項《醫療器械註冊變更文件》，並完成了相關產品的醫療器械產品註冊變更。
一、產品名稱：嬰兒培養箱
註冊證編號：國械注準20193081603；批准日期：2020年12月07日
變更內容：
1、型號規格：由“YP-100、YP-100B”變更為“YP-100、YP-100B、YP-500、YP-500A。”
2、結構及組成：由“由主機[包括嬰兒艙、機箱、控制儀(配套的空氣循環風機：交流或直流)、輸液架及托盤]、機座(機櫃或機腳)、黃疸治療裝置(YP-100無)和皮膚温度傳感器(可選件)組成。”變更為“由主機(包括嬰兒艙、機箱、控制儀、輸液架及托盤)、機座、上黃疸治療裝置、下黃疸治療裝置、皮膚温度傳感器、脈搏血氧監測裝置(含有傳感器延長線但不含血氧傳感器)和稱重裝置組成。”
3、適用範圍：由“YP-100嬰兒培養箱用於早產兒或病弱兒的培養成長；YP-100B嬰兒培養箱用於早產兒或病弱兒的培養成長，以及新生兒高膽紅素血癥的光照治療。”變更為“YP-100嬰兒培養箱用於早產兒或病弱兒的培養成長；YP-100B嬰兒培養箱用於早產兒或病弱兒的培養成長，以及新生兒高膽紅素血癥的光照治療；YP-500、YP-500A嬰兒培養箱用於早產兒或病弱兒的培養成長，新生兒高膽紅素血癥的光照治療，以及動脈血氧飽和度(SpO2)和脈搏率(PR)的連續無創測量。”
二、產品名稱：嬰兒培養箱
註冊證編號：國械注準20193081618；批准日期：2020年12月07日；
變更內容：
1、型號規格：由“YP-970、YP-930、YP-920、YP-910”變更為“YP-910、YP-920、YP-930、YP-970、YP-800、YP-800A、YP-800B、YP-800C。”
2、結構及組成：由“由主機(包括嬰兒艙、機箱、控制儀、輸液架及托盤)、傳感器盒、皮膚温度傳感器、機座(機櫃或升降式機櫃)、黃疸治療裝置(可選件)和稱重裝置(可選件)組成。”變更為“由主機(包括嬰兒艙、機箱、控制儀、輸液架及托盤)、傳感器盒、皮膚温度傳感器、機座、上黃疸治療裝置(YP-910、YP-920、YP-930、YP-970選配)、下黃疸治療裝置(YP-910、YP-920、YP-930、YP-970無)、稱重裝置(選配)、脈搏血氧監測裝置(YP-910、YP-920、YP-930、YP-970無，含有傳感器延長線，但不含血氧傳感器)和攝像頭(選配，YP-910、YP-920、YP-930、YP-970無)組成。”
3、適用範圍：由“用於早產兒或病弱兒的培養成長。”變更為“YP-910、YP-920、YP-930、YP-970用於早產兒或病弱兒的培養成長；YP-800、YP-800A、YP-800B、YP-800C用於早產兒或病弱兒的培養成長，新生兒高膽紅素血癥的光照治療，以及動脈血氧飽和度(SpO2)和脈搏率(PR)的連續無創測量。”
上述《醫療器械註冊證》的變更，有利於進一步提升公司在嬰兒保育設備領域的核心競爭力，對公司未來經營將產生積極影響。
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