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底氣十足“走出去”!海派醫藥防疫物資入選出口“白名單”

發布時間: 2020-07-14

網址:http://www.cccmhpie.org.cn/
海派醫藥總部辦公樓

海派醫藥始創于2004年,歷經十余年發展歷程,已初步形成以中藥材種植、藥品研發、藥品、醫療器械和保健品生產、醫藥流通、終端連鎖、“互聯網+醫藥”六大醫藥板塊為一體的大健康產業集團。現建有10萬級潔凈生產車間,擁有近20條口罩專業生產線,日產成人和兒童防護、醫用口罩、KN95口罩100多萬個。

Haipai Pharmaceutical . was founded in 2004, and has developed into a huge group of health industry integrating six pharmaceutical sectors covering cultivation of Chinese herbs, pharmaceutical research and development, production of medicines, medical apparatus and health products, medicine circulation, terminal chain, and “internet + medicine” after development for more than ten years. Now it has a big clean production workshop and nearly 20 professional production lines of masks, which will produce over 1 million protective masks for adults and children, medical masks and KN95 masks every day.



     公司持有《中華人民共和國醫療器械注冊證》《醫療器械生產許可證》。生產過程按照《醫療器械生產質量管理規范》(2014年第64號)、YY/T0287-2017idtISO13485:2016《醫療器械質量管理體系用于法規的要求》管控運行。

The company holds the Medical Device Registration Certificate of the People’s Republic of China and Medical Device Production License. The production process is controlled under Medical Equipment Production Quality Management Specification (No. 64 of 2014) and YY/T0287-2017idtISO13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.

 
 

“海派醫藥”一次性醫用口罩,嚴格按GB/T 32610-2016、GB 2626-2006、YY/T 0969-2013、T/ZFB 0004—2020等國家及團體標準和歐盟和EN 14683的檢測標準生產。公司產品經國家CNAS和CMA資質授權的檢測單位及歐盟檢測標準授權機構檢測全部合格,同時獲得了歐盟CE認證,并進入商務部“白名單”

The disposable medical masks of “Haipai Pharmaceutical” are produced strictly according to the national and group standards including GB/T 32610-2016, GB 2626-2006, YY/T 0969-2013 and T/ZFB 0004-2020 as well as EU and EN 14683 test standards. All of the company’s products are qualified according to the detection of testing units with CNAS and CMA authorization and authorized agencies of EU test standards. Meanwhile, we have acquired EU’s CE certification , and entered the “white list” of the Ministry of Commerce.




“海派醫藥”各類口罩介紹