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Terviseamet

Medical device

MSA code 17192
UDI code
Seadme klass Meditsiiniseade
Risk class IIb
Appliance -
Device name (in Estonian) Provox LaryTube Fenestrated
Device name (in English) Provox LaryTube Fenestrated
Intended use (is Estonian) Provox LaryTube on seadmete Provox HME System hoidik, mis on mõeldud vokaalseks ja kopsude taastusraviks pärast täielikku lärüngektoomiat.
Kitseneva trahheostoomiga patsientidel kasutatakse seda ka trahhostoomi lahtihoidmiseks hingamisel.
Provox LaryTube on ette nähtud kasutamiseks ainult ühel patsiendil.
Intended use (in English) The Provox LaryTube is a holder for devices in the Provox HME System intended for vocal pulmonary rehabilitation after total laryngectomy.
For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing.
The Provox LaryTube is intended for single patient use.
Type/model/article number 7637; 7638; 7640; 7641; 7643; 7644; 7646; 7647
Notified body 0413
Manufacturer Atos Medical AB
In register from 01/10/2022
Status Active
EHK soodustus EHK soodustus puudub
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