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    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <lastUpdated>2026-07-17T00:44:15.384Z</lastUpdated>
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    <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>
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    <udiDi>D-6602381YX</udiDi>
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    <tradeName>COULTER CLONE B1-FITC</tradeName>
    <deviceName>COULTER CLONE B1-FITC</deviceName>
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    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <udiDi>00382903457847</udiDi>
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    <tradeName>Not Applicable</tradeName>
    <deviceName>CD14 Single Color Reagents</deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
    <manufacturerSrn>US-MF-000017797</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>345784</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:43:32.704Z</lastUpdated>
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    <udiDi>00382903358304</udiDi>
    <basicUdiDi>038290WGOEVGIDG8</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName>ANTI-HLA-DR Single Color Reagents</deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
    <manufacturerSrn>US-MF-000017797</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>335830</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:43:08.302Z</lastUpdated>
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    <udiDi>00382903331383</udiDi>
    <basicUdiDi>038290TCGCKKCD62</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName>Anti-MPO Single Color Reagents</deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
    <manufacturerSrn>US-MF-000017797</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>333138</reference>
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    <lastUpdated>2026-07-15T20:42:57.653Z</lastUpdated>
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    <udiDi>00382903457984</udiDi>
    <basicUdiDi>038290LIUSEUOIHC</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName>CD33 Single Color Reagents</deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
    <manufacturerSrn>US-MF-000017797</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
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    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
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    <reference>345798</reference>
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    <lastUpdated>2026-07-15T20:33:33.709Z</lastUpdated>
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  <row>
    <udiDi>00382903384396</udiDi>
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    <tradeName>Not Applicable</tradeName>
    <deviceName>CD13 Single Color Reagents</deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
    <manufacturerSrn>US-MF-000017797</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>338439</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:33:28.118Z</lastUpdated>
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  <row>
    <udiDi>00382903331420</udiDi>
    <basicUdiDi>038290LHCUKGDF84</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName>CD11B Single Color Reagents</deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
    <manufacturerSrn>US-MF-000017797</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>333142</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:33:22.717Z</lastUpdated>
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  <row>
    <udiDi>00382903350391</udiDi>
    <basicUdiDi>038290BDTSKYDT9X</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName>CD45RA Single Color Reagents</deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
    <manufacturerSrn>US-MF-000017797</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>335039</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:26:53.756Z</lastUpdated>
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    <udiDi>D-PartNumber6603262SL</udiDi>
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    <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>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6603262</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:12:19.032Z</lastUpdated>
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    <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>
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    <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>
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    <udiDi>D-737659S3</udiDi>
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    <tradeName>CYTO-STAT/COULTER CLONE CD8-ECD</tradeName>
    <deviceName>CYTO-STAT/COULTER CLONE CD8-ECD</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
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    <reference>737659</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:06.129Z</lastUpdated>
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    <udiDi>D-737657RX</udiDi>
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    <tradeName>IOTest CD3-PC7</tradeName>
    <deviceName>IOTest CD3-PC7</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:02.131Z</lastUpdated>
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    <udiDi>00382903371860</udiDi>
    <basicUdiDi>038290BDTSKYDT9X</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
    <manufacturerSrn>US-MF-000017797</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>337186</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:27:36.787Z</lastUpdated>
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    <udiDi>00382906666741</udiDi>
    <basicUdiDi>038290BDTSKYDT9X</basicUdiDi>
    <tradeName>Horizon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
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    <reference>666674</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <deviceName></deviceName>
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    <emdnCode>W0103080199</emdnCode>
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