Certifications and Authorizations

Certificazioni di qualità

  • 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.

Marchi CE, FDA DMF & altre Autorizzazioni di Commercializzazione

  • CE MARK of “NUTRILINE, sterile bag for parenteral and enteral nutrition”.
  • CE MARK of “PERILINE®, patient set for peritoneal dialysis”.
  • CE MARK of “COMBYLINE, HAEMOLINE, FLOWLINE, UROLINE, medical devices for infusion and transfusion, sterile”.
  • CE MARK of “UROFLUSH, solution G and UROFLUSH solution R”.
  • CE MARK of “SAFE2®, bags for cryopreservation of stem cells”.
  • CE MARK of “SAFE2® STEMCHOICE®, bag for cryopreservation of stem cells, sterile”.
  • CE MARK of “SAFE2® TISSUECHOICE®, bag for cryopreservation of tissues, sterile”.
  • CE MARK of “FILLCHOICE®, bag with sterile solutions for washing, irrigation and instillation”.
  • CE MARK of “Sterile and apyrogenic solutions for washing and irrigation”.
  • CE MARK of “Solutions for continuous renal replacement therapy, sterile”.
  • 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”.

 

 

 

 

 

 

 

 

 

 

 

  • CE MARK of “SANO3, set for auto hemo-infusion with ozone, sterile”.
  • CE MARK of “Solutions for continuous replacement dialysis therapies”
  • CE MARK of “Medical infusion and transfusion devices, sterile: COMBYLine, IV set for infusion, sterile – HAEMOline, IV set for transfusion, sterile – FLOWLine, IV set for infusion with flow regulator, sterile – UROLine, IV set for urological irrigation, sterile”
  • CE MARK of “Disposable for APD, sterile”.
  • CE MARK of “Collection bags, sterile”.
  • CE MARK of “SAFE2®, bags for cryopreservation of stem cells”.
  • CE MARK of “NUTRILINE, empty bags for parenteral/enteral nutrition and PERILINE, patient connection set”.
  • COLOMBIAN REGISTRATION INVIMA of “NUTRILINE, sterile bag for parenteral and enteral nutrition”.
  • CE MARK of “BREATHCHOICE, double bag for lactose intolerance breath test”.
  • RUSSIAN REGISTRATION of “Polyolefin bags, injection point, vial stopper.

 

  • CE MARK of “Sterile solutions for continuous renal replacement therapies; CITRACHOICE, sterile; MIXSOL, sterile”
  • CE MARK of “FILLCHOICE, with sterile and pyrogen free solutions for washing, instillation and irrigation”.
  • FDA Device Master File n.27342 of “Plastic bags for pharmaceutical solution and their components”.
  • CE MARK of “SANO3, set for auto hemo-infusion with ozone, sterile”.

  • CE MARK of “INFUSIONCOLOGY®, infusion sets designed specifically for oncology”.

  • CE MARK of “SAFE2®, bags for cryopreservation of stem cells – SAFE2® STEMCHOICE®, bag for cryopreservation of stem cells, sterile – SAFE2® TISSUECHOICE®, bag for cryopreservation of tissues, sterile”.

  • CE MARKS of “Non-active devices for injection, infusion, transfusion and dialysis, sterile; Non-active disponsable device, sterile: FILLCHOICE® bag with sterile solutions for washing, irrigation and instillation – Sterile and apyrogenic solutions for washing and irrigation – UROFlush solutio G – Uroflush solutio R – WASHOUT bag with sterile solutions for washing and irrigation – Disposable per APD, sterile – COMBYLine, IV set for infusion, sterile – HAEMOline, IV set for transfusion, sterile – FLOWLine, IV set for infusion with flow regulator, sterile – UROLine, IV set and accessories for urological irrigation, sterile – INFUSIONCOLOGY, infusion sets designed specifically for oncology – SANO3, set for auto hemo-infusion with ozone, sterile – SAFE2®, bags for cryopreservation of stem cells”. SAFE2® STEMCHOICE®, bag for cryopreservation of stem cells, sterile – SAFE2® TISSUECHOICE®, bag for cryopreservation of tissues, sterile – CITRACHOICE, sterile solution for CRRT – Mixsol, sterile solution for CRRT – Haemobic, sterile solution for CRRT”.

  • CE MARK of “Sterile solutions for continuous renal replacement therapies:CITRACHOICE, sterile; MIXSOL, sterile”.
  • CE MARK of “SANO3, set for auto hemo-infusion with ozone, sterile”.
  • CE MARK of “Non-active disponsable devices, sterile: NUTRILINE, empty bags for parenteral/enteral nutrition; PERILINE, patient connection set; Empty collection bags; ADIPOCHOICE®, bags for cryopreservation of tissues, sterile”.

 

  • FDA Device Master III File n.27342 of “Plastic bags for pharmaceutical solutions and their components”.
  • CE MARK of “Liquid for the preservation of corneal graft in hypothermic conditions up to 14 days, sterile: iRESTORE Conservation, sterile”.