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Terviseamet

Medical device

MSA code 17061
UDI code
Seadme klass Meditsiiniseade
Risk class IIb
Appliance -
Device name (in Estonian) J-Plasma® System Generator Kõrgsageduslik Elektrokirurgiline Generaator
Device name (in English) J-Plasma® System Generator High Frequency Electroaurgical Generator
Intended use (is Estonian) Seade J-Plasma System Generator (mis on ettevõtte Apyx Medical seade) on näidustatud raadiosagedusliku energia ja/või heeliumgaasi plasma edastamiseks pehmete kudede lõikamisel, koaguleerimisel ning ablatsioonil avatud ja laparoskoopilistel lõikustel.
Intended use (in English) The J-Plasma System Generator (owned by Apyx Medical) is indicated for delivery of radiofrequency energy and/or helium plasma to cut, coagulate and ablate soft tissue during open and laparascopic surgical procedures.
Type/model/article number APYX-JS3
APYX-RS3
Notified body 0459
Manufacturer Apyx Medical Corporation
Authorised representative EMERGO EUROPE
In register from 11/24/2021
Status Active
EHK soodustus EHK soodustus puudub
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