寶萊特(300246.SZ)獲得兩項醫療器械註冊證
格隆匯9月3日丨寶萊特(300246.SZ)公佈，公司於近日分別獲得國家藥監局、廣東藥監局頒發的2項《醫療器械註冊證》。
其中，產品名稱：檸檬酸消毒液，註冊證編號：國械注準20213100636；註冊分類：Ⅲ類；臨牀用途：適用於帶比例混合系統和加熱系統的血液透析設備的清洗和消毒。
產品名稱：病人監護儀；註冊證編號：粵械注準20212071253；註冊分類：Ⅱ類；臨牀用途：適用於醫療單位對患者的心電(ECG)、心率(HR)、呼吸(RESP)、脈搏血氧飽和度(Sp02)、脈率(PR)、體温(Temp)、無創血壓(NIBP)、輸液滴速(DM)、二氧化碳(CO2)、無創心輸出量(ICG)、總血紅蛋白(SpHb)、碳氧血紅蛋白(SpCO)、高鐵血紅蛋白(SpMet)、腦電(EEG)和呼吸力學(RM)進行監測，並對監測的信息進行顯示、回顧、存儲和打印。其中，P1監護儀支持院內轉運，輸液滴速測量功能用於對除鎮痛藥、化療藥物、胰島素之外液體進行輸液過程中的滴速測量。無創心輸出量(ICG)僅適用於成人。總血紅蛋白(SpHb)、碳氧血紅蛋白(SpCO)和高鐵血紅蛋白(SpMet)測量不適用於新生兒。
公司生產的消毒劑已取得《消毒產品生產企業衞生許可證》，公司已具備液體消毒劑的生產條件，消毒劑屬於血液透析產品的主要外延產品，主要用於各類血液透析機的消毒，是血液透析業務不可或缺的耗材。消毒劑將納入醫療器械管理範疇，現取得國家藥監局頒發的《醫療器械註冊證》，代表公司生產的檸檬酸消毒液產品符合醫療器械產品的要求和技術條件。
公司P系列病人監護儀是公司推出的另一系列高端智能監護儀產品。上述產品獲得醫療器械註冊證是公司進一步推行研發創新、實施產品高端化、差異化、智能化、物聯化、精品化戰略的成果，豐富了公司產品的品類，提高公司的核心競爭力和市場拓展能力。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
