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天晟新材(300169.SZ)取得醫療器械經營許可證及第二類醫療器械經營備案憑證
格隆匯 05-21 19:38

格隆匯5月21日丨天晟新材(300169.SZ)公佈,公司於近日取得了由常州市市場監督管理局頒發的《醫療器械經營許可證》及《第二類醫療器械經營備案憑證》。

《醫療器械經營許可證》經營範圍:2002年分類目錄非IVD批發Ⅲ類醫療器械:6805耳鼻喉科手術器械,6821醫用電子儀器設備,6823醫用超聲儀器及有關設備,6824醫用激光儀器設備,6825醫用高頻儀器設備,6826物理治療及康復設備,6828醫用磁共振設備,6830醫用X射線設備,6845體外循環及血液處理設備,6854手術室、急救室、診療室設備及器具,6856病房護理設備及器具,6858醫用冷療、低温、冷藏設備及器具,6866醫用高分子材料及製品,6870軟件***

2017年分類目錄非IVD批發Ⅲ類醫療器械:01有源手術器械,02無源手術器械,04骨科手術器械,05放射治療器械,06醫用成像器械,07醫用診察和監護器械,08呼吸、麻醉和急救器械,09物理治療器械,10輸血、透析和體外循環器械,14注輸、護理和防護器械,15患者承載器械,16眼科器械,17口腔科器械,18婦產科、輔助生殖和避孕器械,19醫用康復器械,21醫用軟件,22臨牀檢驗器械***

《第二類醫療器械經營備案憑證》經營範圍:2002年分類目錄:非IVD批發:6810矯形外科(骨科)手術器械,6815注射穿刺器械,6820普通診察器械,6822醫用光學器具,儀器及內窺鏡設備,6826物理治療及康復設備,6830醫用X射線設備,6831醫用X射線附屬設備及部件,6840臨牀檢驗分析儀器(體外診斷試劑除外),6841醫用化驗和基礎設備器具,6854手術室、急救室、診療室設備及器具,6856病房護理設備及器具,6857消毒和滅菌設備及器具,6864醫用衞生材料及敷料,6866醫用高分子材料及製品,6870軟件***

2017年分類目錄:批發:01有源手術器械,04骨科手術器械,05放射治療器械,06醫用成像器械,07醫用診察和監護器械,08呼吸、麻醉和急救器械,09物理治療器械,10輸血、透析和體外循環器械,11醫療器械消毒滅菌器械,14注輸、護理和防護器械,15患者承載器械,16眼科器械,17口腔科器械,18婦產科、輔助生殖和避孕器械,19醫用康復器械,21醫用軟件,22臨牀檢驗器械***

公司此次取得《醫療器械經營許可證》及《第二類醫療器械經營備案憑證》後即可開展相關業務活動,有助於公司在相關業務領域的進一步發展。

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