<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800056336007</udiDi>
    <basicUdiDi>B-08800056336007</basicUdiDi>
    <tradeName>PowerChek™ Influenza A&amp;B, RSV Multiplex Real-time PCR Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IR3600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056355008</udiDi>
    <basicUdiDi>B-08800056355008</basicUdiDi>
    <tradeName>PowerChek™ ZIKV / DENV / CHIKV Multiplex Real-time PCR Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R5504</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056361030</udiDi>
    <basicUdiDi>B-08800056361030</basicUdiDi>
    <tradeName>PowerChek™ Adenovirus / Bocavirus Real-time PCR Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R6100T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056362037</udiDi>
    <basicUdiDi>B-08800056362037</basicUdiDi>
    <tradeName>PowerChek™ Parainfluenza Virus 1/2/3 Real-time PCR Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R6200T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056363034</udiDi>
    <basicUdiDi>B-08800056363034</basicUdiDi>
    <tradeName>PowerChek™ RSV A &amp; B/HMV Real-time PCR Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R6300T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056364031</udiDi>
    <basicUdiDi>B-08800056364031</basicUdiDi>
    <tradeName>PowerChek™ Coronavirus 229E / OC43 / NL63 / HKU1 Real-time PCR Kit Ver.1.0</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R6410TA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056369029</udiDi>
    <basicUdiDi>B-08800056369029</basicUdiDi>
    <tradeName>PowerChek™ SARS-CoV-2 Real-time PCR Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IR6902</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056369098</udiDi>
    <basicUdiDi>B-08800056369098</basicUdiDi>
    <tradeName>PowerChek™ SARS-CoV-2, Influenza A&amp;B, RSV Multiplex Real-time PCR Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IR6904</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056369104</udiDi>
    <basicUdiDi>B-08800056369104</basicUdiDi>
    <tradeName>PowerChek™ SARS-CoV-2 Advanced Real-time PCR Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IR6906</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056369234</udiDi>
    <basicUdiDi>B-08800056369234</basicUdiDi>
    <tradeName>PowerChek™ SARS-CoV-2, Influenza A&amp;B Multiplex Real-time PCR Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IR6903Q</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056369296</udiDi>
    <basicUdiDi>B-08800056369296</basicUdiDi>
    <tradeName>PowerChek™ SARS-CoV-2, Influenza A&amp;B, RSV Multiplex Real-time PCR Kit II</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R6905N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056369302</udiDi>
    <basicUdiDi>B-08800056369302</basicUdiDi>
    <tradeName>PowerChek™ SARS-CoV-2, Influenza A&amp;B, RSV Multiplex Real-time PCR Kit II</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R6905Q</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056369333</udiDi>
    <basicUdiDi>B-08800056369333</basicUdiDi>
    <tradeName>PowerChek™ SARS-CoV-2, Influenza A&amp;B Multiplex Real-time PCR Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IR6903N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.701Z</lastUpdated>
  </row>
</eudamedExport>