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The first in Poland!
We were the first in Poland to conduct specialized research on the level of filtration, using a particle size of 60nm/160nm, which corresponds to the SARS-CoV-2 particle.
Our masks meet the requirements of the 149 standard which specifies the parameters in relation to filtration, respiratory resistance, and the so-called leakage (proper adhesion of the mask to the face).
Test certificates
Each of our products has gone through a complicated path of approval for marketing by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, in accordance with current legislation, together with the whole range of tests required to obtain a certificate for each product, performed at the Central Institute for Labour Protection in Łódź and Warsaw.
ISO 13485:2016 Medical Devices – Quality Management System
The ISO 13485 standard is dedicated to medical device manufacturers wishing to demonstrate medical device compliance with EU legislation.
We have the certificate in 4 language versions: Polish, English, German and Slovakian.
Click on the image, to see the document
ISO 13485 Certificate
ISO 13485:2016 Medical Devices – Quality Management System
The ISO 13485 standard is dedicated to medical device manufacturers wishing to demonstrate medical device compliance with EU legislation.
We have the certificate in 4 language versions: Polish, English, German and Slovakian.
Click on the image, to see document
ISO 13485 Certificate
ISO 13485:2016 Medical Devices – Quality Management System
The ISO 13485 standard is dedicated to medical device manufacturers wishing to demonstrate medical device compliance with EU legislation.
We have the certificate in 4 language versions: Polish, English, German and Slovakian.
Click on the image, see to the document
ISO 9001:2015 is an international standard that specifies the requirements
for a Quality Management System (QMS). ISO 9001:2015 certification
is recognized and widely used around the world.
Organizations that are ISO 9001:2015 certified provide a guarantee that the products and services offered meet certain requirements, which translates into an increase in the number of potential customers.
We are certified in 5 language versions:Polish, English, German, French and Spanish.
Click on the image, to see the document
ISO 9001 Certificate
ISO 9001:2015 is an international standard that specifies the requirements
for a Quality Management System (QMS). ISO 9001:2015 certification
is recognized and widely used around the world.
Organizations that are ISO 9001:2015 certified provide a guarantee that the products and services offered meet certain requirements, which translates into an increase in the number of potential customers.
We are certified in 5 language versions:Polish, English, German, French and Spanish.
Click on the image, see to the document
ISO 9001 Certificate
ISO 9001:2015 is an international standard that specifies the requirements
for a Quality Management System (QMS). ISO 9001:2015 certification
is recognized and widely used around the world.
Organizations that are ISO 9001:2015 certified provide a guarantee that the products and services offered meet certain requirements, which translates into an increase in the number of potential customers.
We are certified in 5 language versions:Polish, English, German, French and Spanish.
Click on the image, to see the document
More certificates
Due to the protection of confidential data and legal considerations, we are unable to provide access to all certificates and test results.
If you need to see the technical data, we are able to provide them upon request, which can be expressed through the contact form on the Contact Us subpage.