Committed to Quality

Unique Technologies is committed to providing excellent quality products and service.  We are an ISO 13485 company manufacturing CE Marked products.  We observe the standards of several registries in order to assure that consistent quality products are provided to all customers.

All UniqueEdge products are 100% manufactured in the United States and are U.S. FDA Class I exempt. We encourage you to provide feedback on trials of our products.

Please use these links to download our certificates:

Directive 93/42/EEC Certificate

Unique Technologies is ISO certified. You can download our certificate by clicking on the link below.

ISO 13485:2016 Certificate

ISO 13485:2012 Certificate


U.S. FDA Medical Device
(Class 1, Exempt)


Certificate to Foreign Government Certificate #2530-11-2017