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<eudamedExport entity="devices">
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    <udiDi>08800204300645</udiDi>
    <basicUdiDi>B-08800204300645</basicUdiDi>
    <tradeName>08800204300645</tradeName>
    <deviceName>RADI MTB 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>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:15:02.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300621</udiDi>
    <basicUdiDi>B-08800204300621</basicUdiDi>
    <tradeName>08800204300621</tradeName>
    <deviceName>RADI Monkeypox 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>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:57.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300614</udiDi>
    <basicUdiDi>B-08800204300614</basicUdiDi>
    <tradeName>08800204300614</tradeName>
    <deviceName>RADI Chikungunya 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>W0105040525</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:55.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300607</udiDi>
    <basicUdiDi>B-08800204300607</basicUdiDi>
    <tradeName>08800204300607</tradeName>
    <deviceName>RADI CDZ Virus 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>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:55.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300591</udiDi>
    <basicUdiDi>B-08800204300591</basicUdiDi>
    <tradeName>08800204300591</tradeName>
    <deviceName>RADI West nile virus 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>W0105040526</emdnCode>
    <emdnDescription>WEST NILE VIRUS - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:54.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300270</udiDi>
    <basicUdiDi>B-08800204300270</basicUdiDi>
    <tradeName>08800204300270</tradeName>
    <deviceName>RADI Vibrio cholera 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>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:48.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300225</udiDi>
    <basicUdiDi>B-08800204300225</basicUdiDi>
    <tradeName>08800204300225</tradeName>
    <deviceName>RADI FAST RSV A/B 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>W0105040505</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV012F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:41.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300195</udiDi>
    <basicUdiDi>B-08800204300195</basicUdiDi>
    <tradeName>08800204300195</tradeName>
    <deviceName>RADI Flu-SC2 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>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:37.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300188</udiDi>
    <basicUdiDi>B-08800204300188</basicUdiDi>
    <tradeName>08800204300188</tradeName>
    <deviceName>RADI Yellow Fever Virus 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>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:36.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300201</udiDi>
    <basicUdiDi>B-08800204300201</basicUdiDi>
    <tradeName>08800204300201</tradeName>
    <deviceName>RADI FAST Influenza A/B 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>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV011F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:35.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300171</udiDi>
    <basicUdiDi>B-08800204300171</basicUdiDi>
    <tradeName>08800204300171</tradeName>
    <deviceName>RADI Ebola Virus 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>W0105040528</emdnCode>
    <emdnDescription>EBOLA (FILOVIRUS) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:18.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300164</udiDi>
    <basicUdiDi>B-08800204300164</basicUdiDi>
    <tradeName>08800204300164</tradeName>
    <deviceName>RADI Dengue Virus 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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:17.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300157</udiDi>
    <basicUdiDi>B-08800204300157</basicUdiDi>
    <tradeName>08800204300157</tradeName>
    <deviceName>RADI Rift Valley Fever Virus 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>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:16.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300072</udiDi>
    <basicUdiDi>B-08800204300072</basicUdiDi>
    <tradeName>08800204300072</tradeName>
    <deviceName>RADI FAST COVID-19 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>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV008F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:15.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300065</udiDi>
    <basicUdiDi>B-08800204300065</basicUdiDi>
    <tradeName>08800204300065</tradeName>
    <deviceName>RADI COVID-19 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>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:11.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056362037</udiDi>
    <basicUdiDi>B-08800056362037</basicUdiDi>
    <tradeName>PowerChek™ Parainfluenza Virus 1/2/3 Real-time PCR Kit</tradeName>
    <deviceName>PowerChek™ Parainfluenza Virus 1/2/3 Real-time PCR Kit</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R6200T</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:40.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056330005</udiDi>
    <basicUdiDi>B-08800056330005</basicUdiDi>
    <tradeName>PowerChek™ Influenza B (Victoria &amp; Yamagata) Real-time PCR Kit Ver.1.1</tradeName>
    <deviceName>PowerChek™ Influenza B (Victoria &amp; Yamagata) Real-time PCR Kit Ver.1.1</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R3013TA</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:16.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056302002</udiDi>
    <basicUdiDi>B-08800056302002</basicUdiDi>
    <tradeName>PowerChek™ Norovirus GI / GII Multiplex Real-time PCR Kit</tradeName>
    <deviceName>PowerChek™ Norovirus GI / GII Multiplex Real-time PCR Kit</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040516</emdnCode>
    <emdnDescription>NOROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0210E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:07.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800044300089</udiDi>
    <basicUdiDi>B-08800044300089</basicUdiDi>
    <tradeName>QPLEX</tradeName>
    <deviceName>QPLEX™ COVID-19 Test</deviceName>
    <manufacturerName>QuantaMatrix Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022784</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>QMCOVID02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:49.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719327497906</udiDi>
    <basicUdiDi>B-08719327497906</basicUdiDi>
    <tradeName>RealAccurate® Quadruplex SARS-CoV-2 PCR Kit</tradeName>
    <deviceName>RealAccurate® Quadruplex SARS-CoV-2 PCR Kit</deviceName>
    <manufacturerName>PathoFinder B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000002704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF0971C-R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:28.929Z</lastUpdated>
  </row>
</eudamedExport>