Certification
Our commitment to quality is validated by global regulatory authorities and rigorous international standards.
Trausim FDA 510(k)
U.S. FDA certification for medical devices
Trausim ISO 13485
Quality management system certification
Centrifuge Australia TGA
Australian TGA certificate for centrifuge products
Centrifuge Japan Registration
Japanese market access registration certificate
CE MDD
(September 11, 2019 – January 11, 2024)
CE MDR Statement
Compliance statement for European MDR regulation
CE MDR Certificate
