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喜訊:美國FDA驗廠順利通過-桂林啄木鳥
[2016-12-27]

       三個月前,桂林市啄木鳥醫療接到美國FDA驗廠通知,在經過友好洽談后,桂林市啄木鳥醫療對有20年醫療器械專業經驗的久順企管專家團隊充分信任,決定與久順企管攜手合作,共渡艱難的FDA驗廠準備和FDA驗廠審核。

       近日,桂林市啄木鳥醫療以兩個觀察項的優異成績順利通過美國FDA驗廠,這標志著桂林市啄木鳥醫療的產品質量管理達到了國際先進水平。FDA驗廠的成功,可以讓該公司產品在國際市場上暢通無阻。

       FDA是美國政府在健康與人類服務部和公共衛生部中設立的執行機構之一,它最早是以保護消費者權益為主要職能的聯邦機構之一。作為一家科學管理機構,FDA的職責是確保美國本土生產或進口的食品、化妝品、藥物、生物制劑、醫療設備和放射產品安全。每次驗廠它都是直接派人,從不委托第三方機構進行,所以是號稱世界上最嚴的驗廠。

       桂林市啄木鳥醫療通過美國FDA的工廠生產條件和能力的檢查,無形中形成了產品合格的隱形標志,為公司擴大外貿出口奠定了堅實的基礎,讓國外經銷商增加了對公司產品質量的信任,不但減少了潛在風險,也提高了公司產品的知名度和美譽度。

       桂林市啄木鳥醫療器械有限公司超聲潔牙機全球產銷量遙遙領先,LED光固化機出口量中國領跑者,26年來專注于齒科醫療設備的研發、生產、銷售、服務一體化,是全球產銷量最大的超聲潔牙機研發制造廠商。

       桂林市啄木鳥醫療通過不懈努力和多年積累,現已建成一支具有國際先進技術水準的研發、銷售和管理隊伍,已申請214項國家專利,45項國家發明專利,通過美國FDA認證、TüV德國萊茵公司CE產品認證及EN ISO13485:2012/AC2012、ISO 9001: 2008質量體系認證。

       公司自成立以來,始終秉承質量第一,客戶至上的宗旨,致力于核心技術研發,為廣大用戶提供高性價比的牙科產品,目前公司主要產品占國內85%以上市場份額,并出口至美國、歐盟、俄羅斯、印度等119個主要國家和地區。

       桂林市啄木鳥醫療的主打產品有超聲潔牙機、超聲骨刀機、LED光固化機、根管長度測量儀、牙科手機、手術器械等。

       久順企管(中國●英國●愛爾蘭),美國FDA驗廠專家:400-658-3933,隨時隨地聆聽您的需求!

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