The Salin Plus, Salin S2 and InSalin devices are medically CE class 1 certified. In other words, they are certified for the entire EU. Moreover, the SaltMed Inhaler has a CE class II medical certificate from “Bureau Veritas from Italy” certifier – the most severe certification from the devices produced by us and the reason why we used a certifier from Italy is that in Romania we do not have such certification body. In fact, with the same Bureau Veritas Italia, the medical certification ISO 13485 of the production system for our entire product range is also performed.
These certifications are the result of extremely demanding certification procedures, which involve many tests related primarily to the safety of the device, medical evidence of operation, extremely rigorous production, control, traceability throughout the implementation and use flow.