<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809537078740</udiDi>
    <basicUdiDi>880953707RVP3116ZP</basicUdiDi>
    <tradeName>AccuPower® RV Kit (ExiStation™ FA 96)</tradeName>
    <deviceName>AccuPower® RV Kit (ExiStation™ FA 96)</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVP-3116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:59:13.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809537077866</udiDi>
    <basicUdiDi>880953707NCVM21111JH</basicUdiDi>
    <tradeName>AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit</tradeName>
    <deviceName>AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCVM2-1111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:51.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809537072533</udiDi>
    <basicUdiDi>880953707QRV1113YY</basicUdiDi>
    <tradeName>IRON-qPCR™ RV Kit</tradeName>
    <deviceName>IRON-qPCR™ RV Kit</deviceName>
    <manufacturerName>BIONEER Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000018672</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QRV-1113</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:58:50.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800174502933</udiDi>
    <basicUdiDi>88001745-DUO-R-6Z</basicUdiDi>
    <tradeName>08800174502933</tradeName>
    <deviceName>NX-Duo Genomic DNA Kit A</deviceName>
    <manufacturerName>Genolution Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000010391</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCF242</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:34:41.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800174502377</udiDi>
    <basicUdiDi>88001745-48N-R-NY</basicUdiDi>
    <tradeName>08800174502377</tradeName>
    <deviceName>NX Genomic DNA Kit A</deviceName>
    <manufacturerName>Genolution Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000010391</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVD231</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:34:40.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800174501905</udiDi>
    <basicUdiDi>88001745-JR-R-5N</basicUdiDi>
    <tradeName>08800174501905</tradeName>
    <deviceName>NX-Jr Genomic DNA Kit A</deviceName>
    <manufacturerName>Genolution Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000010391</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FF131</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:34:36.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095210587</udiDi>
    <basicUdiDi>4049095UN13450000R5</basicUdiDi>
    <tradeName>04049095210587</tradeName>
    <deviceName>RIDA®UNITY Viral Stool Panel IV</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN1345</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:57.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095210150</udiDi>
    <basicUdiDi>4049095UN59050000V3</basicUdiDi>
    <tradeName>04049095210150</tradeName>
    <deviceName>RIDA®UNITY RSV &amp; hMPV</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN5905</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:49.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095210075</udiDi>
    <basicUdiDi>4049095UN13250000QB</basicUdiDi>
    <tradeName>04049095210075</tradeName>
    <deviceName>RIDA®UNITY Viral Stool Panel II</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN1325</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:36.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974677692544</udiDi>
    <basicUdiDi>6974677692537K9</basicUdiDi>
    <tradeName>Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-FZ-064-50-CE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:14:03.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974677692537</udiDi>
    <basicUdiDi>6974677692537K9</basicUdiDi>
    <tradeName>Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-FZ-064-25-CE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:14:02.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731721</udiDi>
    <basicUdiDi>B-06955792731721</basicUdiDi>
    <tradeName>Human Herpers Virus 6 DNA Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Human Herpers Virus 6 DNA Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3071E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:31:47.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731509</udiDi>
    <basicUdiDi>B-06955792731509</basicUdiDi>
    <tradeName>06955792731509</tradeName>
    <deviceName>Monkeypox virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3352E-24-P</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:31:17.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731493</udiDi>
    <basicUdiDi>B-06955792731493</basicUdiDi>
    <tradeName>06955792731493</tradeName>
    <deviceName>Monkeypox virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3352E-48</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:31:15.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731486</udiDi>
    <basicUdiDi>B-06955792731486</basicUdiDi>
    <tradeName>06955792731486</tradeName>
    <deviceName>Monkeypox virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3352E-12-P</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:31:11.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937044500804</udiDi>
    <basicUdiDi>B-06937044500804</basicUdiDi>
    <tradeName>06937044500804</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XC32033</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:51:22.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937044500798</udiDi>
    <basicUdiDi>B-06937044500798</basicUdiDi>
    <tradeName>06937044500798</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XC15033</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:51:21.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937044500392</udiDi>
    <basicUdiDi>B-06937044500392</basicUdiDi>
    <tradeName>06937044500392</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XC123</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:51:00.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937044500361</udiDi>
    <basicUdiDi>B-06937044500361</basicUdiDi>
    <tradeName>06937044500361</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XC101</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:55.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937044500354</udiDi>
    <basicUdiDi>B-06937044500354</basicUdiDi>
    <tradeName>06937044500354</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XC98</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:54.712Z</lastUpdated>
  </row>
</eudamedExport>