Certifications
Main tehcnology is the high frequency welding used to produce bags (any kind or field of application) and components (pillows, chambers or others for which this technology is suitable with).
Cert n° 1906/MDD
Enteral and Parenteral feeding bags.
I.V. infusion set and transfusion set.
Bags for enzyme replacement therapy.
FDA – USA – 510K
Empty EVA Bags (K181393) obtained on 15/02/2019.
FDA – USA – 510K
Parenteral nutrition EVA bags (K101412) obtained on 13/04/2011.
ANVISA – BRAZIL
Parenteral nutrition EVA bags (13/10/2014 and 24/11/2014).
INVIMA – COLOMBIA
Parenteral nutrition EVA bags obtained on 10/03/2016.
MDMA KINGDOM OF SAUDI ARABIA
Parenteral nutrition bags and Infusion sets - MDMA16030150 obtained on 20/03/2016.
GCC KINGDOM OF SAUDI ARABIA
(Gulf Country Council) Parenteral nutrition bag and Infusion set – Pending.