CE MaRKS, FDA DMF & OTHER Marketing Authorizations

2004

• CE MARK of "NUTRILINE, sterile bag for parenteral and enteral nutrition".

2005

• 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".

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 "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".»

2010

• COLOMBIAN REGISTRATION INVIMA of "NUTRILINE, sterile bag for parenteral and enteral nutrition".

2011

• CE MARK of "BREATHCHOICE, double bag for lactose intolerance breath test".

• RUSSIAN REGISTRATION of "Polyolefin bags, injection point, vial stopper".

2012

• 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. »

2013

• 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". »

2014

• 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". »

2015

• 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". »

2017

• 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". »»

 

Follow us