• Class I Medical Device pursuant to Regulation (EU) 2017/745. National Classification of Medical Devices (CND) pursuant to Ministerial Decree Min. Health of 8 June 2016: Code T010201. DM registered in the Register of Medical Devices pursuant to Ministerial Decree Min. Health of 20.2.2007 and subsequent amendments. m. the. Complies with EN 455 1,2,3,4 standards.

• Type B Personal Protective Equipment against chemicals and microorganisms, including viruses, to be used for activities falling within risk category III (Regulation (EU) 2016/425). Complies with the technical standards EN ISO 374-1:2016 +A1:2018, EN ISO 374-5:2016 and EN 420:2003 + A1:2009 harmonized with Regulation (EU) 2016/425