CERTIFICATIONS AND AUTHORIZATIONS
Quality Certifications
2015-2016
UNI EN ISO 9001:2015 for the following products/services:
Design and manufacturing of empty bags for cryoconservation, enteral/parenteral nutrition, collecting and drainage, of medical devices for infusion and transfusionnof ozone large autohaemoinfusion sets. Design and manufacturing of solutions for renal therapies, for irrigation, for washing and instillation. Manufacturing of empty infusion or dialysis bags under customers specifications.
UNI CEI EN ISO 13485:2016 for the following products/services:
Design and manufacturing of empty bags for cryoconservation, enteral/parenteral nutrition, collecting and drainage, of medical devices for infusion and transfusion of ozone large autohaemoinfusion sets. Design and manufacturing of solutions for renal therapies, for irrigation, for washing and instillation. Manufacturing of empty infusion or dialysis bags under customers specifications.
CE Marks, FDA DMF & Others M.A.
2004
- CE MARK of “NUTRILINE, sterile bag for parenteral and enteral nutrition”
2005
- CE MARK of “WASHOUT, bag with sterile solutions for washing and irrigation”.
- CE MARK of “CITRACHOICE, sterile solution for CRRT”.
- CE MARK of “MIXSOL, sterile solution for continuous renal replacement therapies”.
2007
- CE MARK of “WASHOUT, bag with sterile solutions for washing and irrigation”.
- CE MARK of “CITRACHOICE, sterile solution for CRRT”.
- CE MARK of “MIXSOL, sterile solution for continuous renal replacement therapies”
2008
- CE MARK of “SANO3, set for auto hemo-infusion with ozone, sterile”
2009
- CE MARK of “Solutions for continuous replacement dialysis therapies”
- CE MARK of “Disposable for APD, sterile”.
- CE MARK of “Collection bags, sterile”.
2010
- COLOMBIAN REGISTRATION INVIMA of “NUTRILINE, sterile bag for parenteral and enteral nutrition”
2011
- RUSSIAN REGISTRATION of “Polyolefin bags, injection point, vial stopper
2013
- FDA Device Master File n.27342 of “Plastic bags for pharmaceutical solution and their components” for Class III
- CE MARK of “SANO3, set for auto hemo-infusion with ozone, sterile”
2014
CE MARK of “INFUSIONCOLOGY®, infusion sets designed specifically for oncology”
2015
CE MARK of “Liquid for the preservation of corneal graft in hypothermic conditions up to 14 days, sterile: iRestore Conservation, sterile”
2017
- CE MARK of “ADIPOCHOICE®, bags for cryopreservation of tissues, sterile”
2019
- CE MARK of “ALIMENTA®, Sterile bags for Total parental Nutrition TPN in polyolefin material”
2020
- CE MARK of “Liquid for the preservation of corneal graft up to 30 days, sterile: iRESTORE Culture”
- Liquid for the deturgescence and transport of the corneal graft at room temperature up to 5 days, sterile: iRESTORE Transport”.