<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00382903411085</udiDi>
    <basicUdiDi>038290CDCIQDHQWB</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName>BD® Anti-Kappa (TB 28-2)</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>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>341108</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:27:00.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382903371662</udiDi>
    <basicUdiDi>038290AGTTMGMZA5</basicUdiDi>
    <tradeName>BD MULTITEST</tradeName>
    <deviceName>BD Multitest™ 6-Color TBNK with BD Trucount™ Tubes</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>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>337166</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:26:59.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382903358229</udiDi>
    <basicUdiDi>038290BTMGDARZ7V</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName>CD8 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>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>335822</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:26:58.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382903358212</udiDi>
    <basicUdiDi>038290AGGQCTDV2K</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName>CD2 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>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>335821</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:26:57.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382903410118</udiDi>
    <basicUdiDi>038290IPDFTPLRAP</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>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>341011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:27:36.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382903410248</udiDi>
    <basicUdiDi>038290AGGQCTDV2K</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>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>341024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:27:36.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382903457960</udiDi>
    <basicUdiDi>038290IPDFTPLRAP</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>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>345796</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:27:36.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382903474042</udiDi>
    <basicUdiDi>038290AGGQCTDV2K</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>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>347404</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:27:36.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382903474059</udiDi>
    <basicUdiDi>038290AGGQCTDV2K</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>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>347405</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T05:27:36.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972825500024</udiDi>
    <basicUdiDi>B-06972825500024</basicUdiDi>
    <tradeName>CD3 FITC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022880</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50T/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:06:59.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590391539</udiDi>
    <basicUdiDi>150995901LSANTIBODYREAQ2</basicUdiDi>
    <tradeName>IOTest CD4-PC7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737660</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:13:29.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590391546</udiDi>
    <basicUdiDi>150995901LSANTIBODYREAQ2</basicUdiDi>
    <tradeName>CD8-ECD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737659</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:13:29.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590391553</udiDi>
    <basicUdiDi>150995901LSANTIBODYREAQ2</basicUdiDi>
    <tradeName>IOTest CD3-PC7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>737657</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:13:29.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974501891037</udiDi>
    <basicUdiDi>69745018900C002401WA</basicUdiDi>
    <tradeName>06974501891037</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Agilent Biosciences (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013066</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8920012CE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:24:46.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974501891013</udiDi>
    <basicUdiDi>69745018900C002301W5</basicUdiDi>
    <tradeName>06974501891013</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Agilent Biosciences (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013066</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8920008CE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:24:46.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590686574</udiDi>
    <basicUdiDi>150995906B74074UC</basicUdiDi>
    <tradeName>ClearLLab Compensation Kit</tradeName>
    <deviceName>ClearLLab Compensation Kit</deviceName>
    <manufacturerName>Beckman Coulter India Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000010115</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B74074</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:08:33.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590686567</udiDi>
    <basicUdiDi>150995906B74073UA</basicUdiDi>
    <tradeName>ClearLLab LS Lymphoid Screen Reagent</tradeName>
    <deviceName>ClearLLab LS Lymphoid Screen Reagent</deviceName>
    <manufacturerName>Beckman Coulter India Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000010115</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B74073</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:08:31.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590701475</udiDi>
    <basicUdiDi>150995902CLEARLLABBP</basicUdiDi>
    <tradeName>ClearLLab Bcell tube</tradeName>
    <deviceName>ClearLLab Panels</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B96805</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:50:19.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590663650</udiDi>
    <basicUdiDi>150995902AQUIOSPLGPANELCT</basicUdiDi>
    <tradeName>AQUIOS PLG Panel 50 Test</tradeName>
    <deviceName>AQUIOS PLG</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B42535</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:49:26.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382906644534</udiDi>
    <basicUdiDi>038290YNAJNVPIJQ</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>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080101</emdnCode>
    <emdnDescription>ANTIBODIES FOR B AND T-CELL SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664453</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:38:39.295Z</lastUpdated>
  </row>
</eudamedExport>