FDA Registered Facilities

We are a proudly U.S. owned and operated company with our headquarters and a full-service manufacturing facility based in Pennsylvania. Utilizing our 30-plus years in business and global resources, we offer additional manufacturing options in lower cost countries.

We Cut Costs — Not Corners

We built our first ISO Quality System in 1998 and were certified as meeting ISO 9002 standards in 1999. In 2005, we met ISO 13485 standards and became FDA Registered. We are currently ISO-13485:2016 certified and our quality system is QSR compliant and fully adheres to the 21 CFR Part 820 regulations. We are rigorously audited by leading global medical device companies on a routine basis.

FDA Registered

Sanbor Medical is a U.S. Corporation with FDA registered contract manufacturing facilities.

View our FDA Registrations Below

View Sanbor Medical U.S. FDA Registration
View Sanbor Medical Xiamen FDA Registration

ISO-13485:2016

ISO Certificate 2026 - US ISO Certificate 2025 - Xiamen

ISO Certified

Sanbor Medical is Certified to ISO-13485:2016 standards.

View Certificate - U.S.
View Certificate - Xiamen

FDA Field Inspected

#of FDA Inspected China Facilities 2019-ver2

FDA Field Inspected

Of the 1302 FDA CDRH inspected facilities in China from 1/1/2009-12/31/2019

259 received NAI (no action indicated) results in Compliance: Devices
11 of them were Electronics Contract Manufacturers
Sanbor Medical was the only Electronics Contract Manufacturer of the 259 with NAI ( zero non-conformities) that exclusively serves the medical industry.

FDA Registered

Sanbor Medical is a U.S. Corporation with FDA registered contract manufacturing facilities.

View our FDA Registrations Below

View Sanbor Medical U.S. FDA Registration
View Sanbor Medical Xiamen FDA Registration

ISO Certificate 2026 - US ISO Certificate 2025 - Xiamen

ISO Certified

Sanbor Medical is Certified to ISO-13485:2016 standards.

View Certificate - U.S.
View Certificate - Xiamen

#of FDA Inspected China Facilities 2019-ver2

FDA Field Inspected

Of the 1302 FDA CDRH inspected facilities in China from 1/1/2009-12/31/2019

259 received NAI (no action indicated) results in Compliance: Devices
11 of them were Electronics Contract Manufacturers
Sanbor Medical was the only Electronics Contract Manufacturer of the 259 with NAI ( zero non-conformities) that exclusively serves the medical industry.

Smarter Manufacturing Starts Here.

Connect with our team to learn how a Sanbor Medical partnership is the future of medical device contract manufacturing.