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    <basicUdiDi>426046567SROrange4T</basicUdiDi>
    <tradeName>Optitrol Orange</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11063</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.885Z</lastUpdated>
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    <udiDi>4260465670330</udiDi>
    <basicUdiDi>426046567SROrange4T</basicUdiDi>
    <tradeName>Optitrol Orange</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11069</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.867Z</lastUpdated>
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    <udiDi>4260465670385</udiDi>
    <basicUdiDi>426046567SRSeroNegZ5</basicUdiDi>
    <tradeName>Optitrol SeroNeg</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.824Z</lastUpdated>
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    <udiDi>4260465670392</udiDi>
    <basicUdiDi>426046567SRSeroNegZ5</basicUdiDi>
    <tradeName>Optitrol SeroNeg</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.801Z</lastUpdated>
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    <udiDi>4260465670439</udiDi>
    <basicUdiDi>426046567SRHEPRJK</basicUdiDi>
    <tradeName>Optitrol HEPR-1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR12047</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.759Z</lastUpdated>
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  <row>
    <udiDi>4260465670446</udiDi>
    <basicUdiDi>426046567SRHEPRJK</basicUdiDi>
    <tradeName>Optitrol HEPR-2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR12055</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.735Z</lastUpdated>
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    <udiDi>4260465670453</udiDi>
    <basicUdiDi>426046567SRHEPRJK</basicUdiDi>
    <tradeName>Optitrol HEPR-2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR12057</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.709Z</lastUpdated>
  </row>
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    <udiDi>4260465670477</udiDi>
    <basicUdiDi>426046567SRHEPAHH</basicUdiDi>
    <tradeName>Optitrol HEPA-1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR12027</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670484</udiDi>
    <basicUdiDi>426046567SRHEPAHH</basicUdiDi>
    <tradeName>Optitrol HEPA-2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR12035</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.644Z</lastUpdated>
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    <udiDi>4260465670491</udiDi>
    <basicUdiDi>426046567SRHEPAHH</basicUdiDi>
    <tradeName>Optitrol HEPA-2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR12037</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670514</udiDi>
    <basicUdiDi>426046567SRHIVp24DE</basicUdiDi>
    <tradeName>Optitrol HIVp24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.589Z</lastUpdated>
  </row>
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    <udiDi>4260465670521</udiDi>
    <basicUdiDi>426046567SRHIVp24DE</basicUdiDi>
    <tradeName>Optitrol HIVp24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11105</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.567Z</lastUpdated>
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    <udiDi>4260465670538</udiDi>
    <basicUdiDi>426046567SRHIVp24DE</basicUdiDi>
    <tradeName>Optitrol HIVp24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11107</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670552</udiDi>
    <basicUdiDi>426046567SRHIV2HT</basicUdiDi>
    <tradeName>Optitrol HIV 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11115</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.503Z</lastUpdated>
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    <udiDi>4260465670569</udiDi>
    <basicUdiDi>426046567SRHIV2HT</basicUdiDi>
    <tradeName>Optitrol HIV 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080803</emdnCode>
    <emdnDescription>RETROVIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11117</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.483Z</lastUpdated>
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    <udiDi>4260465670897</udiDi>
    <basicUdiDi>426046567NTHBVScrCV</basicUdiDi>
    <tradeName>Optitrol NAT  HBV Screening</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.449Z</lastUpdated>
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    <udiDi>4260465670910</udiDi>
    <basicUdiDi>426046567NTHBVVLSQ</basicUdiDi>
    <tradeName>Optitrol NAT HBV Viral Load</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.421Z</lastUpdated>
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    <udiDi>4260465670934</udiDi>
    <basicUdiDi>426046567NTHCVScrD8</basicUdiDi>
    <tradeName>Optitrol NAT HCV Screening</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.383Z</lastUpdated>
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    <udiDi>4260465670958</udiDi>
    <basicUdiDi>426046567NTHCVVLSX</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.346Z</lastUpdated>
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    <udiDi>4260465670972</udiDi>
    <basicUdiDi>426046567NTHIVScrFA</basicUdiDi>
    <tradeName>Optitrol NAT HIV Screening</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.308Z</lastUpdated>
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