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<eudamedExport entity="devices">
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    <udiDi>D-PartNumber17562129</udiDi>
    <basicUdiDi>B-PartNumber17562129</basicUdiDi>
    <tradeName>LeukoSure Enumeration Kit</tradeName>
    <deviceName>LeukoSure Enumeration Kit</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>175621</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:12:18.237Z</lastUpdated>
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  <row>
    <udiDi>D-910201P3</udiDi>
    <basicUdiDi>B-910201P3</basicUdiDi>
    <tradeName>spinit®</tradeName>
    <deviceName>spinit® BC control</deviceName>
    <manufacturerName>biosurfit SA</manufacturerName>
    <manufacturerSrn>PT-MF-000033920</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080402</emdnCode>
    <emdnDescription>LEUCOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910201</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:55:21.390Z</lastUpdated>
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  <row>
    <udiDi>D-75470532Z</udiDi>
    <basicUdiDi>B-75470532Z</basicUdiDi>
    <tradeName>Flow-Count Fluorospheres</tradeName>
    <deviceName>Flow-Count Fluorospheres</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>AUXILIARY &amp; SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547053</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:42.865Z</lastUpdated>
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  <row>
    <udiDi>D-737664RU</udiDi>
    <basicUdiDi>B-737664RU</basicUdiDi>
    <tradeName>PC7 (770/488) SETUP KIT</tradeName>
    <deviceName>PC7 (770/488) SETUP KIT</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080401</emdnCode>
    <emdnDescription>SETUP BEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737664</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:14.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-737663RS</udiDi>
    <basicUdiDi>B-737663RS</basicUdiDi>
    <tradeName>APC (675/633) Setup Kit</tradeName>
    <deviceName>APC (675/633) Setup Kit</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080401</emdnCode>
    <emdnDescription>SETUP BEADS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737663</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:13.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-737662RQ</udiDi>
    <basicUdiDi>B-737662RQ</basicUdiDi>
    <tradeName>IOTest MslgG1-PC7</tradeName>
    <deviceName>IOTest MslgG1-PC7</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737662</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:08.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-737661RN</udiDi>
    <basicUdiDi>B-737661RN</basicUdiDi>
    <tradeName>IOTest CD8-PC7</tradeName>
    <deviceName>IOTest CD8-PC7</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737661</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:07.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-737660RL</udiDi>
    <basicUdiDi>B-737660RL</basicUdiDi>
    <tradeName>IOTest CD4-PC7</tradeName>
    <deviceName>IOTest CD4-PC7</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737660</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:06.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-737659S3</udiDi>
    <basicUdiDi>B-737659S3</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE CD8-ECD</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE CD8-ECD</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737659</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:06.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-737657RX</udiDi>
    <basicUdiDi>B-737657RX</basicUdiDi>
    <tradeName>IOTest CD3-PC7</tradeName>
    <deviceName>IOTest CD3-PC7</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737657</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:02.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-177018PM</udiDi>
    <basicUdiDi>B-177018PM</basicUdiDi>
    <tradeName>QuickComp 2 Kit</tradeName>
    <deviceName>QuickComp 2 Kit</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>AUXILIARY &amp; SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>177018</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:17:29.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-177017PK</udiDi>
    <basicUdiDi>B-177017PK</basicUdiDi>
    <tradeName>QuickComp 4 Kit</tradeName>
    <deviceName>QuickComp 4 Kit</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>AUXILIARY &amp; SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>177017</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:17:27.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-175658QH</udiDi>
    <basicUdiDi>B-175658QH</basicUdiDi>
    <tradeName>Leuko-Trol RBC Control Cells</tradeName>
    <deviceName>Leuko-Trol RBC Control Cells</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>175658</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:17:16.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-175651Q3</udiDi>
    <basicUdiDi>B-175651Q3</basicUdiDi>
    <tradeName>Leuko-Trol Platelet Control Cells</tradeName>
    <deviceName>Leuko-Trol Platelet Control Cells</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080403</emdnCode>
    <emdnDescription>LYMPHOCYTE SUBTYPING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>175651</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:17:15.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>15061002300019</udiDi>
    <basicUdiDi>B-15061002300019</basicUdiDi>
    <tradeName>VISITECT</tradeName>
    <deviceName>VISITECT® CD4 Advanced Disease</deviceName>
    <manufacturerName>AccuBio Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000041152</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080106</emdnCode>
    <emdnDescription>ANTIBODIES FOR LYMPHOCYTE SUBTYPING</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>AB376</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:33:29.670Z</lastUpdated>
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  <row>
    <udiDi>00860015684516</udiDi>
    <basicUdiDi>08600156845FIXPERMCEIVDRQ</basicUdiDi>
    <tradeName>FIX&amp;PERM® Kit 1000 Cell Fixation and Permeabilization kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vector Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057003</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>AUXILIARY &amp; SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAS-002-1-CE/IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:35:31.119Z</lastUpdated>
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    <udiDi>00860015684547</udiDi>
    <basicUdiDi>08600156845FIXPERMCEIVDRQ</basicUdiDi>
    <tradeName>FIX&amp;PERM® Sample Kit Cell Fixation and Permeabilization kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vector Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057003</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>AUXILIARY &amp; SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAS-002M-CE/IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:35:30.363Z</lastUpdated>
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    <udiDi>00860015684523</udiDi>
    <basicUdiDi>08600156845FIXPERMCEIVDRQ</basicUdiDi>
    <tradeName>FIX&amp;PERM® Solution A (Fix) Cell Fixation and Permeabilization kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vector Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000057003</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>AUXILIARY &amp; SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAS-002A-1-CE/IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:35:30.053Z</lastUpdated>
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  <row>
    <udiDi>08683555622495</udiDi>
    <basicUdiDi>B-08683555622495</basicUdiDi>
    <tradeName>Immunoglobulin A Kit</tradeName>
    <deviceName>Immunoglobulin A Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080202</emdnCode>
    <emdnDescription>IGA, IGD, IGM, IGG, IGE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B45190</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:53:30.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555619020</udiDi>
    <basicUdiDi>B-08683555619020</basicUdiDi>
    <tradeName>Immunoglobulin M Kit</tradeName>
    <deviceName>Immunoglobulin M Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080202</emdnCode>
    <emdnDescription>IGA, IGD, IGM, IGG, IGE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B28206</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:50:40.216Z</lastUpdated>
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