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<eudamedExport entity="devices">
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    <udiDi>D-L11-SCD01C4XB</udiDi>
    <basicUdiDi>B-L11-SCD01C4XB</basicUdiDi>
    <tradeName>One Step Sickle cell Test</tradeName>
    <deviceName>One Step Sickle cell Test</deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010109</emdnCode>
    <emdnDescription>SICKLE CELL ANEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L11-SCD01C4</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:50:02.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000054278BMCXJ020HP</udiDi>
    <basicUdiDi>B-USMF000054278BMCXJ020HP</basicUdiDi>
    <tradeName>Sickle SCAN Test</tradeName>
    <deviceName>Sickle SCAN Test</deviceName>
    <manufacturerName>BioMedomics</manufacturerName>
    <manufacturerSrn>US-MF-000054278</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010109</emdnCode>
    <emdnDescription>SICKLE CELL ANEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CXJ020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:09:35.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M803221F7</udiDi>
    <basicUdiDi>B-G2M803221F7</basicUdiDi>
    <tradeName>SCA-Q Real Time PCR Kit (Sickle Cell Anemia)</tradeName>
    <deviceName>SCA-Q Real Time PCR Kit (Sickle Cell Anemia)</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010109</emdnCode>
    <emdnDescription>SICKLE CELL ANEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M803221,G2M803221R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:07.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548257895</udiDi>
    <basicUdiDi>B-08683548257895</basicUdiDi>
    <tradeName>ChainFor Sickle Cell Disease Detection qPCR Kit</tradeName>
    <deviceName>Sickle Cell Disease Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010109</emdnCode>
    <emdnDescription>SICKLE CELL ANEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP92</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:17:29.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548252036</udiDi>
    <basicUdiDi>B-08683548252036</basicUdiDi>
    <tradeName>RapidFor™ Sickle Cell Rapid Test Kit</tradeName>
    <deviceName>Sickle Cell Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010109</emdnCode>
    <emdnDescription>SICKLE CELL ANEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD72</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:13:31.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850031753020</udiDi>
    <basicUdiDi>B-00850031753020</basicUdiDi>
    <tradeName>HemoTypeSC</tradeName>
    <deviceName>HemoTypeSC™ Test Kit – In Vitro Diagnostic – Pack of 50 Tests</deviceName>
    <manufacturerName>Silver Lake Research Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000027373</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010109</emdnCode>
    <emdnDescription>SICKLE CELL ANEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:55.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658552733</udiDi>
    <basicUdiDi>B-04260658552733</basicUdiDi>
    <tradeName>Atlas</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>W0106010109</emdnCode>
    <emdnDescription>SICKLE CELL ANEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.02.67.0.0100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:57.848Z</lastUpdated>
  </row>
</eudamedExport>