底气十足“走出去”!海派医药防疫物资入选出口“白名单”

发布时间: 2020-07-14

网址:http://www.cccmhpie.org.cn/
海派医药总部办公楼

海派医药始创于2004年,历经十余年发展历程,已初步形成以中药材种植、药品研发、药品、医疗器械和保健品生产、医药流通、终端连锁、“互联网+医药”六大医药板块为一体的大健康产业集团。现建有10万级洁净生产车间,拥有近20条口罩专业生产线,日产成人和儿童防护、医用口罩、KN95口罩100多万个。

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《中华人民共和国医疗器械注册证》《医疗器械生产许可证》。生产过程按照《医疗器械生产质量管理规范》(2014年第64号)、YY/T0287-2017idtISO13485:2016《医疗器械质量管理体系用于法规的要求》管控运行。

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.

 
 

“海派医药”一次性医用口罩,严格按GB/T 32610-2016、GB 2626-2006、YY/T 0969-2013、T/ZFB 0004—2020等国家及团体标准和欧盟和EN 14683的检测标准生产。公司产品经国家CNAS和CMA资质授权的检测单位及欧盟检测标准授权机构检测全部合格,同时获得了欧盟CE认证,并进入商务部“白名单”

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.




“海派医药”各类口罩介绍