Class IIB 93/42/EEC for ABU v01
The ABU v01 emergency mechanical ventilator, produced by PBL SRL in a joint project with Omnidermal, has obtained CE class IIb certification according to European Directive 93/42/EEC in a record time of 6 months, demonstrating the company’s ability to capitalize transversal synergies.
Class I 93/42/EEC for WoundViewer
WoundViewer (WV02) the device based on the use of Artificial Intelligence and designed for intelligent wound monitoring, is now available on the market as a class I medical device according to the European Directive 93/42 / EEC.
CE certification as a class IIa medical device, following the new European Medical Device Regulation (EU) 2017/745, is expected by the end of 2021.
Despite the young age of the company, Omnidermal was hyper focused on the development of a quality system that could meet the highest standards required by the companies involved in the medical sector. This has made possible the achievement of ISO 13485 certification of its quality system.