We put our products through a series of tests and procedures to guarantee the safety and top quality. Here you can find the full list of certificates that demonstrates that.
Determination of bacterial filtration efficiency (BFE)
Various tests performed to determine the bacterial filtration efficiency of our masks. The results confirmed our BFE ≥ 98% compliance.
Issued by Biochem.
Determination of a population of microorganisms on products
Various ISO-verified tests performed to determine the population of microorganisms on our masks. The results confirmed our compliance with EN 14683:2019 5.2.5 Microbial cleanliness (Bioburden).
Issued by Biochem.
Test of “Splash Resistance”
This ISO-verified test evaluates the resistance of our masks to the penetration of a certain volume of synthetic blood. The results indicate that our masks could be classifiable as Type IIR.
Issued by Tecnopolo di Mirandola.
Registration of medical devices in the Register of Manufacturers Medical Devices
Entered the Register of Medical Device Manufacturers of the National Agency for Medical Products.
Issued by the National Agency for Medical Products.
Certificates
Download the following PDF files to find out more details about our certificates.
| Attachment | Size |
|---|---|
| Determination of bacterial filtration efficiency (BFE) | 140.8 KB |
| Determination of a population of microorganisms on products | 134.54 KB |
| Test of “Splash Resistance” | 796.25 KB |
| Register of Manufacturers Medical Devices - Greek | 2.34 MB |
| Register of Manufacturers Medical Devices - English | 3.21 MB |
| Register of Manufacturers Medical Devices - German | 2.99 MB |