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Terviseamet

Medical device

MSA code 13685
UDI code
Seadme klass Meditsiiniseade
Risk class IIb
Appliance -
Device name (in Estonian) SoftPac Citrate, tsitraadipõhine hemodialüüsi happekontsentraat
Device name (in English) SoftPac Citrate, citrate based acid concentrate for hemodialysis
Intended use (is Estonian) Toode on mõeldud kasutamiseks tsitraadipõhise happekontsentraadina koos kuiva naatriumvesinikkarbonaadi kolbampulliga hemodialüüsi, hemodiafiltratsiooni- või hemofiltratsiooni vedelike on-line ettevalmistamiseks
Intended use (in English) Product is intended to be used as a citrate based acid concentrate together with a dry sodium bicarbonate cartridge for on-line preparation
of hemodialysis, hemodiafiltration and hemofiltration fluids
Type/model/article number SoftPac Citrate C
SoftPac Citrate G
Notified body 2797
Manufacturer Bieffe Medital S.p.A.
In register from 05/30/2019
Status Active
EHK soodustus EHK soodustus puudub
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