INFOMED FLUIDS S.r.l.
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1 e / 1 di / of 10 Certificato CE del Sistema di Garanzia della Qualità/ EC Quality Assurance System Certificate Si certifica che, sulla base dei risultati degli audit effettuati, il Sistema completo di garanzia di Qualità dell Organizzazione/ We certify that, on the basis of the audits carried out, the full Quality Assurance System of the Organization: INFOMED FLUIDS S.r.l. Sede Legale e Operativa / Registered and operational headquarter: Bld Theodor Pallady, Sector 3 - BUCAREST - Romania è conforme ai requisiti applicabili della Direttiva 93/42/CEE e successive modifiche ed integrazioni, Allegato II escluso il pto 4, attuata in Italia con Dlgs. 46 del 1997/02/24 e successive modifiche ed integrazioni per le seguenti tipologie di Dispositivi Medici/ Is in compliance with the applicable requirements of 93/42/EEC Directive as amended, Annex II without point 4, transposed in Italy by Dlgs. 46 of 1997/02/24 as amended for the following Medical Devices: Soluzione sterile apirogene per l anticoagulazione del sangue nelle terapie renali / Sterile and pyrogene-free solution for the anticoagulation of blood for use in continous renal replacement therapies (CRRT) Soluzioni concentrate per emodialisi in sacche di PVC / Hemodialysis concentrate solutions in PVC bags Soluzioni per terapie renali sostitutive continue in sacche di PP e PVC / Continous renal replacement solutions in PP and PVC bags Soluzioni sterili anticoagulanti per aferesi / Sterile anticoagulant solution for apheresis. Soluzioni sterili per irrigazione e lavaggi / Sterile and apyrogene solution for irrigation and rinsing
2 e / 2 di / of 10 Soluzione sterile apirogene per l anticoagulazione del sangue nelle terapie renali / Sterile and pyrogene-free solution for the anticoagulation of blood for use in continous renal replacement therapies (CRRT) Infomed Fluids Citrato di sodio 4% ; ACD A soluzione anticoagulante 10XXXX (10 indica la famiglia di prodotto XXXX indica la tipologia di prodotto) Soluzioni concentrate per emodialisi in sacche di PVC / Hemodialysis concentrate solutions in PVC bags INFOSOL INFOSOL A INFOSOL A GL. 5 INFOSOL A 101.5
3 e / 3 di / of 10 Soluzioni concentrate per emodialisi in sacche di PVC / Hemodialysis concentrate solutions in PVC bags INFOSOL INFOSOL A GL. 11 INFOSOL A GL. 5 INFOSOL A GL. 5 INFOSOL A INFOSOL A INFOSOL A GL. 11
4 e / 4 di / of 10 Soluzioni concentrate per emodialisi in sacche di PVC / Hemodialysis concentrate solutions in PVC bags INFOSOL INFOSOL A GL. 5 INFOSOL A INFOSOL A GL. 11 INFOSOL A GL. 5 INFOSOL A INFOSOL A GL. 5
5 e / 5 di / of 10 Soluzioni concentrate per emodialisi in sacche di PVC / Hemodialysis concentrate solutions in PVC bags INFOSOL INFOSOL A INFOSOL A GL.5 INFOSOL A INFOSOL A GL. 5 Soluzioni per terapie renali sostitutive continue in sacche di PP e PVC / Continous renal replacement solutions in PP and PVC bags DIMI LACSOL DIMI-LACSOL , DIMI-LACSOL , DIMI-LACSOL
6 e / 6 di / of 10 Soluzioni per terapie renali sostitutive continue in sacche di PP e PVC / Continous renal replacement solutions in PP and PVC bags INFOHEMO DG 400 soluzioni A e B / DG 400 solution A and B DG 400, DGK 200, DGK 400, D400 DGK 200 soluzioni A e B / DGK 200 solution A and B DGK 400 soluzioni A e B / DGK 400 solution A and B INFOHEMO DIAL INFOHEMO DIAL 1, INFOHEMO DIAL 2, INFOHEMO DIAL 3, INFOHEMO DIAL XX
7 e / 7 di / of 10 Soluzioni sterili anticoagulanti per aferesi / Sterile anticoagulant solution for apheresis. Infomed Fluids SOLUZIONE SODIUM CITRATE 4%; ACD-A SOLUZIONE ANTICOAGULANTE 10XXXX (10 indica la famiglia di prodotto XXXX indica la tipologia di prodotto) Soluzioni sterili per irrigazione e lavaggi / Sterile and apyrogene solution for irrigation and rinsing INFOMED FLUIDS Acqua per irrigazione (ml 100, ml 250, ml 500, ml 3000, ml 4000, ml 5000) / Water for irrigation (ml 100, ml 250, ml 500, ml 3000, ml 4000, ml 5000) Soluzione con glicina 1,5% (ml 3000, ml 5000) / Glycine 1,5% Solution (ml 3000, ml 5000) Soluzione con glicina e mannitolo (ml 3000, ml 5000) / Glycine and mannitol solution (ml 3000, ml 5000)
8 e / di / of 10 Soluzioni sterili per irrigazione e lavaggi / Sterile and apyrogene solution for irrigation and rinsing INFOMED FLUIDS Soluzione con Mannitolo e sorbitolo (ml 3000, ml 5000) / Mannitol and sorbitol (ml 3000, ml 5000) Soluzione con Sodio cloruro 0,9% (ml 50, ml 100, ml 250, ml 500, ml 1000, ml 2000, ml 3000, ml 4000, ml 5000) / Sodium chloride 0,9% solution (ml 50, ml 100, ml 250, ml 500, ml 1000, ml 2000, ml 3000, ml 4000, ml 5000) Soluzione Curi Flush G / Curi Flush Solution G Soluzione Curi Flush NaCl 0,9% / Curi Flush Solution NaCl 0,9% Soluzione Curi Flush R / Curi Flush Solution R
9 e / 9 di / of 10 Soluzioni sterili per irrigazione e lavaggi / Sterile and apyrogene solution for irrigation and rinsing INFOMED FLUIDS Soluzione polisalina bilanciata oftalmica (ml 250, ml 500) / Balanced salt ophtalmic solution( 250ml, 500ml) Soluzione UROFlush Solutio G / UROFlush Solution G Soluzione UROFlush Solutio NaCl 0,9% / UROFlush solution NaCl 0,9% Soluzione UROFlush Solutio R / UROFlush Solution R
10 e / 10 di / of 10 La lista completa dei codici, relativi ai modelli certificati, è disponibile presso Kiwa Cermet Italia./ The complete list of the codes related to the certificated models is available at Kiwa Cermet Italia. Il presente Certificato è soggetto al rispetto dei requisiti contrattuali di Kiwa Cermet Italia ed è valido solo per le tipologie di dispositivi sopra identificate soggette a sorveglianza/ This Certificate is subject to Kiwa Cermet Italia regulations and it is valid only for the above mentioned Medical Devices that are subject to survey. L allegato tecnico è parte integrante del presente Certificato./ The technical sheet is an integrating part of this Certificate.
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