News

Posted: August 27, 2009 | News, Press

AMSure HME received CE clearance

Amsino Medical Group has recently received the CE certificate of HME product.  This means that the HME products can be CE-marked for commercial distribution in the European Union market.

“This would allow our customers to market this important product in the European market, along with other respiratory devices we have already developed for the region”, said Gang Chen, Vice President of Quality Assurance and Regulatory Affairs of Amsino Medical Group. 

Headquartered in Pomona, California, Amsino Medical Group is a leading developer and manufacturer of disposable medical devices dedicated to advancing healthcare worldwide by developing, manufacturing, and marketing medical products that help improve the safety and effectiveness of patient care. Amsino products are mostly developed in the US, manufactured in China, and distributed in the United States and more than 30 countries worldwide.    

 Shanghai, August 11, 2009 – Amsino Medical Group has recently received the 510 (k) approval (K091699) by FDA clearing Amsino’s AMSure Hydrophilic Latex Foley Catheter for marketing and commercial distribution in the United States. 
“This approval allows Amsino to offer a complete urological product portfolio so that we can better service our customers in the U.S.”, said Gang Chen, Vice President of Quality Assurance and Regulatory Affairs of Amsino Medical Group. 

Headquartered in Pomona, California, Amsino Medical Group is a leading developer and manufacturer of disposable medical devices dedicated to advancing healthcare worldwide by developing, manufacturing, and marketing medical products that help improve the safety and effectiveness of patient care. Amsino products are mostly developed in the US, manufactured in China, and distributed in the United States and more than 50 countries worldwide. (www.amsino.com)

 For additional information, please contact Ms. Alice Sheng at [email protected]