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title: Certifications and Registrations | Sanbor Medical
---
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# 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 became TUV Certified having met ISO 13485 standards and became FDA Registered. We are currently UL certified to ISO-13485:2016 standards 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
### FDA Registered
Sanbor Medical is a U.S. Corporation with FDA registered contract manufacturing facilities.
#### View our FDA Registrations
[View Sanbor Medical U.S. FDA Registration](https://www.sanbormedical.com/hubfs/Certs%20and%20Graphics/FDA/SMUS%20FDA%20Registration.png?hsLang=en)
[View Sanbor Medical Xiamen FDA Registration](https://www.sanbormedical.com/hubfs/Certs%20and%20Graphics/FDA/SMXM%20FDA%20Registration%20(1).png?hsLang=en)
[View Sanbor Medical Malaysia FDA Registration](https://www.sanbormedical.com/hubfs/Certs%20and%20Graphics/FDA/Sanbor%20Malaysia%20FDA%20Registration.png?hsLang=en)
ISO-13485:2016
### UL Certified
Sanbor Medical is UL Certified to **ISO-13485:2016 **standards through June 26, 2025.
[ View UL Certificate ](https://www.sanbormedical.com/hubfs/Certs%20and%20Graphics/ISO%20Certificate%202023.pdf?hsLang=en)
FDA Field Inspected
#### FDA Field Inspected
Sanbor Medical's quality system is QSR compliant and fully adheres to the 21 CFR Part 820 regulations. We routinely pass rigorous audits by some of the leading medical device companies in the world.
### FDA Registered
Sanbor Medical is a U.S. Corporation with FDA registered contract manufacturing facilities.
#### View our FDA Registrations
[View Sanbor Medical U.S. FDA Registration](https://www.sanbormedical.com/hubfs/Certs%20and%20Graphics/FDA/SMUS%20FDA%20Registration.png?hsLang=en)
[View Sanbor Medical Xiamen FDA Registration](https://www.sanbormedical.com/hubfs/Certs%20and%20Graphics/FDA/SMXM%20FDA%20Registration%20(1).png?hsLang=en)
[View Sanbor Medical Malaysia FDA Registration](https://www.sanbormedical.com/hubfs/Certs%20and%20Graphics/FDA/Sanbor%20Malaysia%20FDA%20Registration.png?hsLang=en)
### UL Certified
Sanbor Medical is UL Certified to **ISO-13485:2016 **standards through June 26, 2025.
[ View UL Certificate ](https://www.sanbormedical.com/hubfs/Certs%20and%20Graphics/ISO%20Certificate%202023.pdf?hsLang=en)
#### FDA Field Inspected
Sanbor Medical's quality system is QSR compliant and fully adheres to the 21 CFR Part 820 regulations. We routinely pass rigorous audits by some of the leading medical device companies in the world.
## Smarter Manufacturing Starts Here.
Connect with our team to learn how a Sanbor Medical partnership is the future of medical device contract manufacturing.
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Corporate Headquarters | 7584 Morris Court Suite 218, Allentown PA, 18106 |[ 610-530-8500](tel:610-530-8500)
