<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-660379528</udiDi>
    <basicUdiDi>B-660379528</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE MsIgG1-RD1/MsIgG2a-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE MsIgG1-RD1/MsIgG2a-FITC</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>6603795</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:48.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-66037962A</udiDi>
    <basicUdiDi>B-66037962A</basicUdiDi>
    <tradeName>CYTO-STAT/COULTER CLONE MsIgG1-RD1/MsIgG1-FITC</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE MsIgG1-RD1/MsIgG1-FITC</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>6603796</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:46.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6603511YT</udiDi>
    <basicUdiDi>B-6603511YT</basicUdiDi>
    <tradeName>COULTER CLONE MY4-FITC</tradeName>
    <deviceName>COULTER CLONE MY4-FITC</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>6603511</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:32.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6603473ZC</udiDi>
    <basicUdiDi>B-6603473ZC</basicUdiDi>
    <tradeName>IMMUNO-BRITE Standards Kit</tradeName>
    <deviceName>IMMUNO-BRITE Standards 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>6603473</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:30.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6603446Z9</udiDi>
    <basicUdiDi>B-6603446Z9</basicUdiDi>
    <tradeName>COULTER CLONE B1-RD1</tradeName>
    <deviceName>COULTER CLONE B1-RD1</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>6603446</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:28.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6603274Z4</udiDi>
    <basicUdiDi>B-6603274Z4</basicUdiDi>
    <tradeName>COULTER CLONE T8-RD1</tradeName>
    <deviceName>COULTER CLONE T8-RD1</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>6603274</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:27.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6603262YV</udiDi>
    <basicUdiDi>B-6603262YV</basicUdiDi>
    <tradeName>COULTER CLONE MY4-RD1</tradeName>
    <deviceName>COULTER CLONE MY4-RD1</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>6602884</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:27.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6603024YB</udiDi>
    <basicUdiDi>B-6603024YB</basicUdiDi>
    <tradeName>CC B4-RD1</tradeName>
    <deviceName>CC B4-RD1</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>6603024</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:25.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6603020Y3</udiDi>
    <basicUdiDi>B-6603020Y3</basicUdiDi>
    <tradeName>COULTER CLONE T1-RD1 (CD5-RD1)</tradeName>
    <deviceName>COULTER CLONE T1-RD1 (CD5-RD1)</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>6603020</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:22.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6603012Y4</udiDi>
    <basicUdiDi>B-6603012Y4</basicUdiDi>
    <tradeName>COULTER CLONE B4-FITC</tradeName>
    <deviceName>COULTER CLONE B4-FITC</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>6603012</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:22.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6602928ZR</udiDi>
    <basicUdiDi>B-6602928ZR</basicUdiDi>
    <tradeName>COULTER Clone MsIgG1-FITC</tradeName>
    <deviceName>COULTER Clone MsIgG1-FITC</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>6602928</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:22.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-660286823</udiDi>
    <basicUdiDi>B-660286823</basicUdiDi>
    <tradeName>COULTER CLONE T11-RD1 (CD2-RD1)</tradeName>
    <deviceName>COULTER CLONE T11-RD1 (CD2-RD1)</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>6602868</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:18.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6602864ZQ</udiDi>
    <basicUdiDi>B-6602864ZQ</basicUdiDi>
    <tradeName>COULTER CLONE T4-RD1</tradeName>
    <deviceName>COULTER CLONE T4-RD1</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>6602864</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:15.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6602393Z6</udiDi>
    <basicUdiDi>B-6602393Z6</basicUdiDi>
    <tradeName>COULTER CLONE T4-FITC</tradeName>
    <deviceName>COULTER CLONE T4-FITC</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>6602393</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:15.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6602389ZF</udiDi>
    <basicUdiDi>B-6602389ZF</basicUdiDi>
    <tradeName>COULTER CLONE T11-FITC</tradeName>
    <deviceName>COULTER CLONE T11-FITC</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>6602389</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:15.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6602385Z7</udiDi>
    <basicUdiDi>B-6602385Z7</basicUdiDi>
    <tradeName>COULTER CLONE T8-FITC</tradeName>
    <deviceName>COULTER CLONE T8-FITC</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>6602385</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:13.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6602381YX</udiDi>
    <basicUdiDi>B-6602381YX</basicUdiDi>
    <tradeName>COULTER CLONE B1-FITC</tradeName>
    <deviceName>COULTER CLONE B1-FITC</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>6602381</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:44:08.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972227431995</udiDi>
    <basicUdiDi>B-06972227431995</basicUdiDi>
    <tradeName>06972227431995</tradeName>
    <deviceName>IL-1beta/IL-2/IL-4/IL-5/IL-6/IL-8/IL-10/IL-12p70/IL-17/IFN-gamma/TNF-alpha/IFN-alpha detection kit(Flow cytometry)</deviceName>
    <manufacturerName>Qingdao Raisecare Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033899</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080699</emdnCode>
    <emdnDescription>REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:10:41.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700575002465</udiDi>
    <basicUdiDi>570057R0301P3006C016201M4</basicUdiDi>
    <tradeName>Monoclonal Mouse Anti-Human Terminal Deoxynucleotidyl Transferase/ iFluor 700, Clone DAK-TDT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Agilent Technologies Singapore (International) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000014448</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080201</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR RECOGNIZING ENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF002</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:05:39.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860015684509</udiDi>
    <basicUdiDi>08600156845FIXPERMCEIVDRQ</basicUdiDi>
    <tradeName>FIX&amp;PERM® Cell Fixation and Permeabilization kit</tradeName>
    <deviceName>FIX&amp;PERM®</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-CE/IVD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:58:51.871Z</lastUpdated>
  </row>
</eudamedExport>