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| EMDDB code |
20696
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| Basic UDI-DI |
07540184F230029
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| Seadme klass |
Meditsiiniseade
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| Medical Device Nomenclature |
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| Risk class |
IIa
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| Appliance |
-
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| Device name (in Estonian) |
OptoMonitor 3
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| Device name (in English) |
OptoMonitor 3
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| 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.
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| 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.
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| Type/model/article number |
F2310, F2320, F2321, F2330
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| Notified body |
2797
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| Manufacturer |
Opsens Inc.
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| Authorised representative |
MDSS GmbH
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| In register from |
06/20/2024
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| Entry status |
Active
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| Reimbursed by EHIF |
Tervisekassa soodustus puudub
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