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戴維醫療(300314.SZ):新生兒黃疸治療箱完成醫療器械產品註冊變更
格隆匯 12-21 16:20

格隆匯 12 月 21日丨戴維醫療(300314.SZ)公佈,公司於近日取得由浙江省藥品監督管理局頒發的1項《醫療器械註冊變更文件》,公司產品新生兒黃疸治療箱完成了醫療器械產品註冊變更。

註冊證編號:浙械注準20182260033;產品名稱:新生兒黃疸治療箱;批准日期:2020年12月16日;

變更內容:

1、型號規格:由“XHZ”變更為“XHZ-100,XHZ-100A,XHZ-100B,XHZ-100C,XHZ-200,XHZ-200A”。

2、結構及組成:由“產品由上箱體(含上燈箱(光源為LED或燈管可選)、控制儀、嬰兒牀)及下箱體(含下燈箱(光源為LED)、儲物櫃)組成。”變更為“產品由上箱體[含上燈箱(XHZ-100A、XHZ-100C光源為LED、XHZ-100、XHZ-100B光源為燈管、XHZ-200、XHZ-200A光源為LED燈管)、控制儀、硅膠牀墊(XHZ-100、XHZ-100A、XHZ-100B、XHZ-100C可選配,XHZ-200、XHZ-200A無硅膠牀墊)]、下箱體[含下燈箱(XHZ-100、XHZ-100A、XHZ-100B、XHZ-100C光源為LED,XHZ-200、XHZ-200A光源為LED燈管)、儲物櫃和機架(XHZ-100、XHZ-100A、XHZ-100B、XHZ-100C無機架,XHZ-200、XHZ-200A有機架並可選配升降式機架)]、嬰兒牀組成。”

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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