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    <udiDi>08800056348000</udiDi>
    <basicUdiDi>88000563KE48005Y</basicUdiDi>
    <tradeName>PowerEXP™ 48LH</tradeName>
    <deviceName>PowerEXP™ 48LH</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KE4800</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:44.555Z</lastUpdated>
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    <udiDi>08800056300060</udiDi>
    <basicUdiDi>88000563E00195H</basicUdiDi>
    <tradeName>PowerPrep™ Pathogen NA Extraction Kit EXP</tradeName>
    <deviceName>PowerPrep™ Pathogen NA Extraction Kit EXP</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E0019</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:40.548Z</lastUpdated>
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    <udiDi>08800056300046</udiDi>
    <basicUdiDi>88000563E00185F</basicUdiDi>
    <tradeName>PowerPrep™ Whole blood NA Extraction Kit EXP</tradeName>
    <deviceName>PowerPrep™ Whole blood NA Extraction Kit EXP</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E0018</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:39.778Z</lastUpdated>
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    <udiDi>08800056300022</udiDi>
    <basicUdiDi>88000563E00175D</basicUdiDi>
    <tradeName>PowerPrep™ Viral NA Extraction Kit EXP</tradeName>
    <deviceName>PowerPrep™ Viral NA Extraction Kit EXP</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E0017</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:39.076Z</lastUpdated>
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  <row>
    <udiDi>08800056300015</udiDi>
    <basicUdiDi>88000563E00165B</basicUdiDi>
    <tradeName>PowerPrep™ Viral DNA/RNA Extraction Kit Ver.1.0</tradeName>
    <deviceName>PowerPrep™ Viral DNA/RNA Extraction Kit Ver.1.0</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E0016</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:26:37.356Z</lastUpdated>
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  <row>
    <udiDi>08800056300039</udiDi>
    <basicUdiDi>88000563E00175D</basicUdiDi>
    <tradeName>PowerPrep™ Viral NA Extraction Kit EXP</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E0017S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:51.199Z</lastUpdated>
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  <row>
    <udiDi>08800056300053</udiDi>
    <basicUdiDi>88000563E00185F</basicUdiDi>
    <tradeName>PowerPrep™ Whole blood NA Extraction Kit EXP</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E0018S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:51.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056300091</udiDi>
    <basicUdiDi>88000563E00195H</basicUdiDi>
    <tradeName>PowerPrep™ Pathogen NA Extraction Kit EXP</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E0019S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:51.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056301005</udiDi>
    <basicUdiDi>B-08800056301005</basicUdiDi>
    <tradeName>PowerChek™ MTB/NTM 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>IR0120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:51.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056301159</udiDi>
    <basicUdiDi>B-08800056301159</basicUdiDi>
    <tradeName>PowerChek™ Salmonella Triplex 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>R0152E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:51.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056302002</udiDi>
    <basicUdiDi>B-08800056302002</basicUdiDi>
    <tradeName>PowerChek™ Norovirus GI / GII 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>R0210E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:51.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056302019</udiDi>
    <basicUdiDi>B-08800056302019</basicUdiDi>
    <tradeName>PowerChek™ Adeno / Astro / Rota 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>R0211E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:51.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056313008</udiDi>
    <basicUdiDi>B-08800056313008</basicUdiDi>
    <tradeName>PowerChek™ 18 RV Panel 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>CQ13TTO6002Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:51.056Z</lastUpdated>
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  <row>
    <udiDi>08800056315002</udiDi>
    <basicUdiDi>B-08800056315002</basicUdiDi>
    <tradeName>PowerChek™ 20 Bacterial Panel 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>R1501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:51.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056319017</udiDi>
    <basicUdiDi>B-08800056319017</basicUdiDi>
    <tradeName>PowerChek™ STI Multiplex Real-time PCR KitⅡ</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>CQ19TTO0002Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:51.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056319024</udiDi>
    <basicUdiDi>B-08800056319024</basicUdiDi>
    <tradeName>PowerChek™ STI Multiplex Real-time PCR Kit Ⅲ</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>CQ19TTO0003Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:51.019Z</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></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>R3013TA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:51.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056331002</udiDi>
    <basicUdiDi>B-08800056331002</basicUdiDi>
    <tradeName>PowerChek™ MeV / MeVA 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>R3136TA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056331019</udiDi>
    <basicUdiDi>B-08800056331019</basicUdiDi>
    <tradeName>PowerChek™ Mumps Real-time PCR Kit Ver.1.1</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>R3110TA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056331026</udiDi>
    <basicUdiDi>B-08800056331026</basicUdiDi>
    <tradeName>PowerChek™ Measles virus 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>R3130TA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T13:19:50.971Z</lastUpdated>
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