<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00861841000204</udiDi>
    <basicUdiDi>B-00861841000204</basicUdiDi>
    <tradeName>SIRA-1000</tradeName>
    <deviceName>SIRA RFA Electrosurgical Device</deviceName>
    <manufacturerName>Innoblative Designs, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044282</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2050240</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:11.796Z</lastUpdated>
  </row>
</eudamedExport>