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 certified according to the Standard GB 2626-2019 with report No. FZ202833 resulting in a filtering efficiency equal or above 99.97% of suspended particles with diameter of 0.3 micrometers or larger.
Being an electronic device it also certified CE Standard 61000-6-1:2007 and 6100-6-3:2007+A1:2011 in compliance with the European Electromagnetic Compatibility Directive 2014/30/EU.
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.