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<eudamedExport entity="devices">
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    <udiDi>08800111722219</udiDi>
    <basicUdiDi>88001117IPCA01MA22XG</basicUdiDi>
    <tradeName>STANDARD™ M10 MRSA/SA</tradeName>
    <deviceName>STANDARD™ M10 MRSA/SA</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11MSS10A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:33:09.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045510449</udiDi>
    <basicUdiDi>54200455DIAGPFMRSADE</basicUdiDi>
    <tradeName>Panther Fusion MRSA Assay Controls</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04805</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:16.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022241</udiDi>
    <basicUdiDi>8488380CoagulasePlasmaLJ</basicUdiDi>
    <tradeName>COAGULASE PLASMA 15ML</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011299</emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21051</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022258</udiDi>
    <basicUdiDi>8488380CoagulasePlasmaLJ</basicUdiDi>
    <tradeName>COAGULASE PLASMA 25ML</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011299</emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21052</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022265</udiDi>
    <basicUdiDi>8488380CoagulasePlasmaLJ</basicUdiDi>
    <tradeName>COAGULASE PLASMA 5ML PK/6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011299</emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658550081</udiDi>
    <basicUdiDi>B-04260658550081</basicUdiDi>
    <tradeName>Atlas Staphylococcus Latex , 100 Tests</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011299</emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.12.0.0100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:33:26.230Z</lastUpdated>
  </row>
</eudamedExport>