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<eudamedExport entity="devices">
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    <udiDi>05032384127825</udiDi>
    <basicUdiDi>5032384MicrobactVPQE</basicUdiDi>
    <tradeName>MICROBACT REAGENT VP II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB0184A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:13.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384127832</udiDi>
    <basicUdiDi>5032384MicrobactNitrateED</basicUdiDi>
    <tradeName>MICROBACT REAGENT NITRATE A</tradeName>
    <deviceName>MICROBACT REAGENT NITRATE</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB0186A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:13.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384127849</udiDi>
    <basicUdiDi>5032384MicrobactNitrateED</basicUdiDi>
    <tradeName>MICROBACT REAGENT NITRATE B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB0187A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:13.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384127856</udiDi>
    <basicUdiDi>5032384MicrobactIndoleNE</basicUdiDi>
    <tradeName>MICROBACT INDOLE KOVACS</tradeName>
    <deviceName>MICROBACT INDOLE KOVACS</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB0209A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:13.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384127917</udiDi>
    <basicUdiDi>5032384MicrobactReagent6X</basicUdiDi>
    <tradeName>MICROBACT REAGENT SET D</tradeName>
    <deviceName>MICROBACT REAGENT SET D</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB1082A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:13.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060536830675</udiDi>
    <basicUdiDi>506053683BCK055</basicUdiDi>
    <tradeName>Bisulfite Conversion Kit</tradeName>
    <deviceName>Bisulfite Conversion Kit</deviceName>
    <manufacturerName>EntroGen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022721</manufacturerSrn>
    <authorisedRepresentativeName>TANJA TOPOVSEK S.P.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000022518</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCK-RT50</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:48:00.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060536830583</udiDi>
    <basicUdiDi>506053683GDNA01ZD</basicUdiDi>
    <tradeName>pureNA® Genomic DNA Isolation Kit</tradeName>
    <deviceName>pureNA® Genomic DNA Isolation Kit</deviceName>
    <manufacturerName>EntroGen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022721</manufacturerSrn>
    <authorisedRepresentativeName>TANJA TOPOVSEK S.P.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000022518</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDNA-50</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:47:59.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060536830576</udiDi>
    <basicUdiDi>506053683CFDNA1ZS</basicUdiDi>
    <tradeName>pureNA® Cell-Free DNA Isolation Kit</tradeName>
    <deviceName>pureNA® Cell-Free DNA Isolation Kit</deviceName>
    <manufacturerName>EntroGen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022721</manufacturerSrn>
    <authorisedRepresentativeName>TANJA TOPOVSEK S.P.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000022518</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFDNA-50</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:47:55.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273207002</udiDi>
    <basicUdiDi>50552732AZNDPSN050X4</basicUdiDi>
    <tradeName>ZINC DEPROTEINIZING SOLUTION (Zn)</tradeName>
    <deviceName>ZINC DEPROTEINIZING SOLUTION (Zn)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZN2607</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:46.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273206142</udiDi>
    <basicUdiDi>50552732ARANDIL045EE</basicUdiDi>
    <tradeName>RANSOD DILUENT (RANSOD DIL)</tradeName>
    <deviceName>RANSOD DILUENT (RANSOD DIL)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD124</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:40.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273206111</udiDi>
    <basicUdiDi>50552732ASALDIL007DT</basicUdiDi>
    <tradeName>NORMAL SALINE (NS)</tradeName>
    <deviceName>SALINE DILUENT</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA3854</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:39.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273205961</udiDi>
    <basicUdiDi>50552732AISEDIL005DG</basicUdiDi>
    <tradeName>I.S.E. URINE DILUENT (ISE DIL URN)</tradeName>
    <deviceName>I.S.E. URINE DILUENT (ISE DIL URN)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX3950</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:33.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273204667</udiDi>
    <basicUdiDi>50552732ASERDIL048KT</basicUdiDi>
    <tradeName>SERUM DILUENT (DIL SM)</tradeName>
    <deviceName>SERUM DILUENT (DIL SM)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS5007</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:28.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562433926</udiDi>
    <basicUdiDi>4987562UF-CELLSHEATHLK</basicUdiDi>
    <tradeName>UF-CELLSHEATH</tradeName>
    <deviceName>UF-CELLSHEATH</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BY-074-501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:41:28.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486043768</udiDi>
    <basicUdiDi>4987486BC0109274HC</basicUdiDi>
    <tradeName>Hemolysis Solution</tradeName>
    <deviceName>Hemolysis Solution</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109274</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:56.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033776</udiDi>
    <basicUdiDi>4987486BC0107378HB</basicUdiDi>
    <tradeName>HEMOLYSIS WASHING SOLUTION Lite H</tradeName>
    <deviceName>HEMOLYSIS WASHING SOLUTION Lite H</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107378</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:34.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033745</udiDi>
    <basicUdiDi>4987486BC0107375H5</basicUdiDi>
    <tradeName>DILUENT 90</tradeName>
    <deviceName>DILUENT 90</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107375</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:15.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033738</udiDi>
    <basicUdiDi>4987486BC0107374H3</basicUdiDi>
    <tradeName>HEMOLYSIS WASHING SOLUTION 90H</tradeName>
    <deviceName>HEMOLYSIS WASHING SOLUTION 90H</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107374</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:14.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033554</udiDi>
    <basicUdiDi>4987486BC0107350GM</basicUdiDi>
    <tradeName>CONTROL DILUTION SET 80</tradeName>
    <deviceName>CONTROL DILUTION SET 80</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107350</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:07.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486033547</udiDi>
    <basicUdiDi>4987486BC0107349H4</basicUdiDi>
    <tradeName>HEMOLYSIS WASHING SOLUTION 80H</tradeName>
    <deviceName>HEMOLYSIS WASHING SOLUTION 80H</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107349</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:03.512Z</lastUpdated>
  </row>
</eudamedExport>