<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00847627029102</udiDi>
    <basicUdiDi>B-00847627029102</basicUdiDi>
    <tradeName>Ki-67  [MIB-1]</tradeName>
    <deviceName>Ki-67  [MIB-1]</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080204</emdnCode>
    <emdnDescription>PROLIFERATION MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPAI3156T60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:24.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627028778</udiDi>
    <basicUdiDi>B-00847627028778</basicUdiDi>
    <tradeName>Ki-67  [MIB-1]</tradeName>
    <deviceName>Ki-67  [MIB-1]</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080204</emdnCode>
    <emdnDescription>PROLIFERATION MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALI3156G7</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:22.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627023933</udiDi>
    <basicUdiDi>B-00847627023933</basicUdiDi>
    <tradeName>Ki-67  [MIB-1]</tradeName>
    <deviceName>Ki-67  [MIB-1]</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080204</emdnCode>
    <emdnDescription>PROLIFERATION MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVI3156G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:25:50.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627004420</udiDi>
    <basicUdiDi>B-00847627004420</basicUdiDi>
    <tradeName>Ki-67  [MIB-1]</tradeName>
    <deviceName>Ki-67  [MIB-1]</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080204</emdnCode>
    <emdnDescription>PROLIFERATION MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>API3156H</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:24:23.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627004413</udiDi>
    <basicUdiDi>B-00847627004413</basicUdiDi>
    <tradeName>Ki-67  [MIB-1]</tradeName>
    <deviceName>Ki-67  [MIB-1]</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080204</emdnCode>
    <emdnDescription>PROLIFERATION MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>API3156AA</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:24:22.393Z</lastUpdated>
  </row>
</eudamedExport>