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<eudamedExport entity="devices">
  <row>
    <udiDi>D-EBX-017-48CW</udiDi>
    <basicUdiDi>B-EBX-017-48CW</basicUdiDi>
    <tradeName>EurobioPlex Coxiella Burnetii</tradeName>
    <deviceName>EurobioPlex Coxiella Burnetii</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011603</emdnCode>
    <emdnDescription>COXIELLA BURNETII (Q FEVER) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-017-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:18.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-017-24CG</udiDi>
    <basicUdiDi>B-EBX-017-24CG</basicUdiDi>
    <tradeName>EurobioPlex Coxiella Burnetii</tradeName>
    <deviceName>EurobioPlex Coxiella Burnetii</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011603</emdnCode>
    <emdnDescription>COXIELLA BURNETII (Q FEVER) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-017-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:17.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-001-UNFK</udiDi>
    <basicUdiDi>B-EBX-001-UNFK</basicUdiDi>
    <tradeName>EurobioPlex Bordetella pertussis et parapertussis</tradeName>
    <deviceName>EurobioPlex Bordetella pertussis et parapertussis</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-001-UN</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:27:12.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-001-24AT</udiDi>
    <basicUdiDi>B-EBX-001-24AT</basicUdiDi>
    <tradeName>EurobioPlex Bordetella pertussis et parapertussis</tradeName>
    <deviceName>EurobioPlex Bartonella pertussis et parapertussis</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-001-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:27:10.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-001-48B9</udiDi>
    <basicUdiDi>B-EBX-001-48B9</basicUdiDi>
    <tradeName>EurobioPlex Bordetella pertussis et parapertussis</tradeName>
    <deviceName>EurobioPlex Bartonella pertussis et parapertussis</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-001-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:27:08.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-888501395GBStoolJB</udiDi>
    <basicUdiDi>B-888501395GBStoolJB</basicUdiDi>
    <tradeName>Great Basin Stool Bacterial Pathogens Panel</tradeName>
    <deviceName>Great Basin Stool Bacterial Pathogens Panel</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300780</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:33.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-888501395GBBordVC</udiDi>
    <basicUdiDi>B-888501395GBBordVC</basicUdiDi>
    <tradeName>Great Basin Bordetella Direct Test</tradeName>
    <deviceName>Great Basin Bordetella Direct Test</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300782</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:33.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002ABPTS02JB59</udiDi>
    <basicUdiDi>B-81649002ABPTS02JB59</basicUdiDi>
    <tradeName>D-81649002ABPTS02JB59</tradeName>
    <deviceName>Bordetella Pertussis Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABPTS02-AHG48E/ ABPTS02-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:59:22.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908020139477</udiDi>
    <basicUdiDi>B-08908020139477</basicUdiDi>
    <tradeName>Truenat GBS</tradeName>
    <deviceName>Truenat GBS</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601240025</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:30:45.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908020139194</udiDi>
    <basicUdiDi>B-08908020139194</basicUdiDi>
    <tradeName>Truenat LTS</tradeName>
    <deviceName>Truenat LTS</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011604</emdnCode>
    <emdnDescription>LEPTOSPIRA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601400020</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:30:39.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908020139187</udiDi>
    <basicUdiDi>B-08908020139187</basicUdiDi>
    <tradeName>Truenat LTS</tradeName>
    <deviceName>Truenat® LTS</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011604</emdnCode>
    <emdnDescription>LEPTOSPIRA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601400005, 601400020, 601400025, 601400050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:30:39.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908020139217</udiDi>
    <basicUdiDi>B-08908020139217</basicUdiDi>
    <tradeName>Truenat LTS</tradeName>
    <deviceName>Truenat LTS</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011604</emdnCode>
    <emdnDescription>LEPTOSPIRA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601400050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:30:38.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908020139200</udiDi>
    <basicUdiDi>B-08908020139200</basicUdiDi>
    <tradeName>Truenat LTS</tradeName>
    <deviceName>Truenat LTS</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011604</emdnCode>
    <emdnDescription>LEPTOSPIRA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601400025</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:30:37.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989750</udiDi>
    <basicUdiDi>B-08908007989750</basicUdiDi>
    <tradeName>Truenat GBS</tradeName>
    <deviceName>Truenat GBS</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601240050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:27:03.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989743</udiDi>
    <basicUdiDi>B-08908007989743</basicUdiDi>
    <tradeName>Truenat GBS</tradeName>
    <deviceName>Truenat GBS</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601240020</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:27:01.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908007989736</udiDi>
    <basicUdiDi>B-08908007989736</basicUdiDi>
    <tradeName>Truenat GBS</tradeName>
    <deviceName>Truenat GBS</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601240005, 601240020, 601240025, 601240050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:27:00.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300287</udiDi>
    <basicUdiDi>B-08800204300287</basicUdiDi>
    <tradeName>08800204300287</tradeName>
    <deviceName>RADI Shigella spp Detection KIT</deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011614</emdnCode>
    <emdnDescription>SHIGELLA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:49.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300249</udiDi>
    <basicUdiDi>B-08800204300249</basicUdiDi>
    <tradeName>08800204300249</tradeName>
    <deviceName>RADI Brucella spp Detection KIT</deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011601</emdnCode>
    <emdnDescription>BRUCELLA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:43.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685115807977</udiDi>
    <basicUdiDi>B-08685115807977</basicUdiDi>
    <tradeName>LyoSens Bordetella pertussis/parapertussis/holmesii Genotyping qPCR Kit</tradeName>
    <deviceName>Bordetella pertussis/parapertussis/holmesii Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO145</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:23:11.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685115807274</udiDi>
    <basicUdiDi>B-08685115807274</basicUdiDi>
    <tradeName>LyoSens Haemophilus influenzae/Neisseria meningitidis/Streptococcus pneumoniae qPCR Kit</tradeName>
    <deviceName>Haemophilus influenzae/Neisseria meningitidis/Streptococcus pneumoniae qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO142</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:23:03.818Z</lastUpdated>
  </row>
</eudamedExport>