Global Regulatory Approvals
International Recognition
KKT has obtained the following regulatory health approvals:
- Food and Drug Administration (FDA) U.S.A
- Health Canada
- State Food and Drug Administration (SFDA) China
To meet stringent medical device registration KKT Systems have been tested and approved by the following authorities:
- TUV Rheinland of North America
- Canadian Standards Association (CSA)
- UL US Products Standard
Certificates of Compliance include:
- CE Certification
- Quality Management System Compliant (ISO 13485:2003).
