<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>07540276340514</udiDi>
    <basicUdiDi>7540276BPP4610MP</basicUdiDi>
    <tradeName>Edge BioCeramic RetroFill</tradeName>
    <deviceName>iRoot BP Plus Root Repair Material</deviceName>
    <manufacturerName>Innovative BioCeramix Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023003</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010201</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DENTAL PASTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USEBIORMEU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:26:50.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540276312016</udiDi>
    <basicUdiDi>7540276SP4608RA</basicUdiDi>
    <tradeName>Edge BioCeramic Sealer</tradeName>
    <deviceName>iRoot SP Injectable Root Canal Sealer</deviceName>
    <manufacturerName>Innovative BioCeramix Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023003</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010202</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USEBIOCSEU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:26:49.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540276321513</udiDi>
    <basicUdiDi>7540276SP4608RA</basicUdiDi>
    <tradeName>Edge BioCeramic ThermalFlow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovative BioCeramix Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023003</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010202</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DENTAL CEMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USEBIOTFEU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:06.810Z</lastUpdated>
  </row>
</eudamedExport>