Quality Management System 

TOOsonix introduced a Quality Management System according to ISO13485:2016 in 2018.

We are very proud to work with TÜV SÜD, known as the preferred single source for worldwide compliance with medical device regulations, as our certifying body.

Please download our latest ISO13485 certificate here.


RoHS Certificate

Commercial products produced by TOOsonix conforms to the requirements set out in the RoHS legislation.

Please download our certificate here.


REACH Certificate

Please note that ultrasound transducers often contain a piezoelectric element manufactured from a material called Lead Zirconate Titanate (CAS no. 12626-81-2) as its main constituent. The European Chemicals Agency, ECHA, has added this material to its list of the candidate SVHC chemicals as toxic for reproduction in accordance with Article 57c of the REACH directive (toxic for reproduction, Cat 1). Our REACH certificate therefore include information about this specific material.

Please download the REACH certificate here.


Terms and Conditions for Sale

Please download our standard Terms and Conditions for Sale here.

How it works

See a short video of a HIFU treatment in the clinic here

Meet the experts

Meet some of the leading M.D.s using our HIFU devices here

Before and After

See  examples of the results of our HIFU treatments here