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Ravimiamet
FOR VISUALLY IMPAIRED

Medical device

EMDDB code 22318
Basic UDI-DI 0690103D001CS1000MR
Seadme klass Meditsiiniseade
Medical Device Nomenclature
Risk class IIa
Appliance -
Device name (in Estonian) Läbivoolukorpus
Device name (in English) Flow-through housing
Intended use (is Estonian) CO-Set+ suletud süstimise manustussüsteem on ette nähtud kasutamiseks termodilutsiooni süstelahuse (kasutatakse südame minutimahu määramiseks) termodilutsiooni kateetrisse manustamise teena.
Intended use (in English) The CO-Set+ closed injectate delivery system is intended to be a pathway to deliver thermodilution injectate (used to make cardiac output determinations) into a thermodilution catheter.
Type/model/article number 93505
Notified body 0123
Manufacturer Edwards Lifesciences LLC
Authorised representative Edwards Lifesciences GmbH
In register from 07/03/2025
Entry status Active
Device comments, keywords MDR
Reimbursed by EHIF Tervisekassa soodustus puudub
Documents related to medical device model
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