Our
Certifications.
U-Mask is more than just a face mask.
It is a technological revolution.
Latest BFE Tests
BFE tests are performed on every production lot and regularly updated
BFE Test (internal to external) - lot 10
BFE - Bacterial Filtration Efficiency test - which measures the filtration capacity of tissues compared to the bacteria tested
FEBRUARY 2021
BFE Test (external to internal) - lot 10
BFE - Bacterial Filtration Efficiency test - which measures the filtration capacity of tissues compared to the bacteria tested
FEBRUARY 2021
Tests of compliance with the standard EN14683:2019
Breathability test
It appears that U-Mask Model Two complies with the breathability requirements of the standard (paragraph 5.2.7 and appendix C) for type IIR masks
Biocompability
It appears that the contact of U-Mask Model Two with the skin does not represent any type of significant risk for the wearer - (Alma Mater Studiorum University of Bologna).
Microbial Cleanliness (Bioburden)
It turns out that U-Mask Model Two meets the microbial cleaning requirements of the standard - (Alma Mater Studiorum University of Bologna).
Resistance to Blood Spatter
It turns out that U-Mask Model Two is resistant to synthetic blood splatters
Biological evaluation of medical devices
It appears that U-Mask Model Two does not pose a risk in terms of cytotoxicity, sensitization and skin irritation - (Alma Mater Studiorum University of Bologna).
Additional Tests
Evaluation of the toxicological profile
Evaluation of the toxicological profile (made on a voluntary basis), which demonstrates that the active principle anti-proliferative and self-sanitizing contained in U-Mask Model Two can be considered safe from a biological point of view. Made by Vitroscreen laboratory of Milano.
BioLayer ™ aging and efficacy test over time
Aging and efficacy test of the active ingredient, which establishes the duration of the antibacterial action - (Clodia Laboratories).
Microscopic investigation on the BioLayer™
Microscopic investigation of the microorganisms deposited on the fibers of the BioLayer ™ and observation of the destructive action of the cell membranes of the various pathogens tested - (Clodia Laboratories).
Registrations and Acknowledgements
Declaration of Conformity CE
Latest declaration of conformity for post Brexit updates. We declare that U-Mask Model Two complies with the EN14683: 2019 standard.
Seal of Excellence UE
Seal of Excellence obtained by the European Commission for the U-Mask Model Two project as part of the COVID-19 projects.
First BFE tests
Initial BFE Report
Mandatory conclusive report of the BFE test - Bacteria Filtration Efficiency - that measures the filtration coefficient of the masks, made with Clodia Laboratories of Bolzano when presenting the tests at Ministery of Health on 18/03/2020. The attached document has been digitally signed according to the normative [art. 20, comma 1bis del Codice dell'Amministrazione Digitale (d.lgs. 82/2005 e successive modifiche)].