About XNY > Manufacturing

XNY Medical is a recognized and eminent surgical stapling manufacture that has become internationally accepted for quality, customer care and performance products. XNY Medical has been working over 30 years to achieve“Meticulous Design, Diligent Manufacture, Honest Management and Assured Application”.

Quality assurance tests are conducted on circuit board calibration, mechanical assemblies, unit comprehension and related processes. For assuring reliable quality of all medical devices produced, all production facilities are based in China.

Advanced Manufacturing Facilities & Well-Trained Human Recourses

Manufacturing facilities and an environment that surpasses national standards (GMP) Well-trained and experienced production force Efficient and accurate design flow

Front-to-End

Integration of mechanical designing and mold fabrication Integration of the electronic design and SMD process Development of testing instruments & devices for production automation

Quality Assurance

XNY adapts rapidly to any OEM/ODM demands and with its flexible production and implementation of ERP and conformation to GMP, ISO 9001, ISO 13485 and IEEE, XNY has made it possible for efficient diversification to take place

World-Class Quality Assurance

Being a quality oriented company, XNY offers a best-in-class, worldwide medical device quality management system that enables the company to meet stringent quality and process controls.

 

Our Quality System Control Center was established in 2000, which is combined by 5 different sections: Document Control Center, Auditing Section, Medical System Section, Complaint Handling Unit, and Return Merchandise Authorization.

XNY’s Quality System Certificates

Certificates

● CE TUV
● ISO 13485: 2003
● GMP
● SFDA
● FDA

Address: No.51 Shuishan Road, Zhonglou Economic Development District, Changzhou, Jiangsu, China. Zip code: 213023

By phone: +86 13585302619 By e-mail: Justin.medical@xnystaplers.com

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