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Terviseamet
FOR VISUALLY IMPAIRED

Medical device

MSA code 20696
Basic UDI-DI 07540184F230029
Seadme klass Meditsiiniseade
Medical Device Nomenclature
Risk class IIa
Appliance -
Device name (in Estonian) OptoMonitor 3
Device name (in English) OptoMonitor 3
Intended use (is Estonian) OptoMonitor 3 on ette nähtud kardiovaskulaarse vererõhu mõõtmiseks sekkumisprotseduuride ajal, sealhulgas südamekambrites, pärgarterites ja perifeersetes veresoontes.
Vererõhu mõõtmine annab veresoonehaiguste diagnostikaks ja raviks vajalikku hemodünaamilist teavet, nagu fraktsionaalne voolureserv ja klapi gradiendid struktuuriliste protseduuride ajal.
Intended use (in English) The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels, and peripheral vessels, during interventional procedures.
Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.
Type/model/article number F2310, F2320, F2321, F2330
Notified body 2797
Manufacturer Opsens Inc.
Authorised representative MDSS GmbH
In register from 06/20/2024
Entry status Active
Reimbursed by EHIF Tervisekassa soodustus puudub
Documents related to medical device model
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