SONOPRO is classified by the FDA as a type-II medical device. It is registered with the FDA under product code MEC.
April 10, 2023 the FDA publicly listed the SONOPRO automated disinfection device under product MEC. It is listed it on the FDAs AccessGUDID "Global Unique Device Identification Database" database.
On August 16, 2023 the FDA publicly listed the new "Global Medical Device Nomenclature" (GMDN) Term Code for this new category of "Automated Disinfector" device.
RESTEC is at the forefront of this new disinfection technology, and is the first manufacturer to register products with the newly recognized GMDN Term Code "Atomized-chemical device disinfector".
RESTEC Solutions LLC, PO Box 11, Glenshaw, PA 15116 | RESTEC Solutions is a Pennsylvania LLC Corporation Ver 2.3