Ultramasx Technologies is registered with the U.S. Food and Drug Administration with operator number 10079960 while our flagship product Ultramasx UltraOne™ is registered with listing number D432175 and D432516 as respirator and surgical face mask for general public/healthcare personnel per IIE guidance.
Ultramasx UltraOne™ is tested with Standard GB 2626-2019 with report number FZ202833 for the filtering efficiency on suspended particles with diameter of 0.3 micrometers or larger. Result: Equal or higher of 99.97%. Classified as grade KN100.
Ultramasx UltraOne™ is tested with Standard UNI EN 14683:2019 Annex B with report number 2100311ec for determining bacterial filtration efficiency (BFE). Result: 99.96%. Classified as mask Type IIR.
Ultramasx UltraOne™ is tested with Standard UNI EN 14683:2019 par 5.2.5 + Annex D with report number 2100311ec for determining microbial cleaning. Bioburden Result: Below 6 UFG/g. Pass level: Equal or below 30 UFG/g. Classified as mask Type IIR.
Ultramasx UltraOne™ is tested with Standard ISO 22609:2004 with report number 2100311ec for resistance to penetration of synthetic blood (fixed volume, horizontal spray). Result: 32 pass, 0 fail. Classified as mask Type IIR.
Ultramasx UltraOne™ is tested with Standard ISO 10993-5:2009 Annex A + ISO 10993-12:2012 with report number 2100311ec for in vitro cytotoxicity. Result: 97.6. The sample is considered not cytoxic if value is equal or above 70.
Being an electronic device it also certified CE with Standards 61000-6-3:2007+A1:2011+AC:2012; EN IEC 61000-6-1:2019; EN IEC 61000-3-2:2019; EN 61000-3-3:2013+A1:2019 with test report AST2103202012 and certificate of conformity AST2103202012EMC.
Last but not least it is also certified according to the EU RoHS Directive 2011/65/EU and its amendments which certifies the absence of toxic materials like lead, cadmium, mercury and hexavalent chromium.