<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>15099590665890</udiDi>
    <basicUdiDi>150995903B36297SH</basicUdiDi>
    <tradeName>15099590665890</tradeName>
    <deviceName>CD14-FITC</deviceName>
    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>B36297</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:55:52.332Z</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>15099590669300</udiDi>
    <basicUdiDi>150995903B36295SD</basicUdiDi>
    <tradeName>15099590669300</tradeName>
    <deviceName>CD11b-APC-Alexa Fluor 750</deviceName>
    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>B36295</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:49:58.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590665876</udiDi>
    <basicUdiDi>150995903B36294SB</basicUdiDi>
    <tradeName>CD45-Krome Orange</tradeName>
    <deviceName>CD45-Krome Orange</deviceName>
    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>B36294</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:49:40.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590665869</udiDi>
    <basicUdiDi>150995903B36293S9</basicUdiDi>
    <tradeName>CD22-APC-Alexa Fluor 700</tradeName>
    <deviceName>CD22-APC-Alexa Fluor 700</deviceName>
    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>B36293</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:49:39.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590665852</udiDi>
    <basicUdiDi>150995903B36292S7</basicUdiDi>
    <tradeName>CD16-Pacific Blue</tradeName>
    <deviceName>CD16-Pacific Blue</deviceName>
    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>B36292</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:49:39.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590665845</udiDi>
    <basicUdiDi>150995903B36291S5</basicUdiDi>
    <tradeName>Anti-HLA-DR-Pacific Blue</tradeName>
    <deviceName>Anti-HLA-DR-Pacific Blue</deviceName>
    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>B36291</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:49:38.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590665838</udiDi>
    <basicUdiDi>150995903B36290S3</basicUdiDi>
    <tradeName>CD7-APC-Alexa Fluor 700</tradeName>
    <deviceName>CD7-APC-Alexa Fluor 700</deviceName>
    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>B36290</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:49:34.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590665821</udiDi>
    <basicUdiDi>150995903B36289SJ</basicUdiDi>
    <tradeName>CD33-PC5.5</tradeName>
    <deviceName>CD33-PC5.5</deviceName>
    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>B36289</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:49:33.365Z</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>15099590663575</udiDi>
    <basicUdiDi>150995903B36286SC</basicUdiDi>
    <tradeName>CD13-ECD</tradeName>
    <deviceName>CD13-ECD</deviceName>
    <manufacturerName>IMMUNOTECH SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>B36286</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:49:25.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590540272</udiDi>
    <basicUdiDi>150995901LSMABEA</basicUdiDi>
    <tradeName>CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent</tradeName>
    <deviceName>CYTO-STAT tetraCHROME</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>IVDR 2017/746</legislation>
    <emdnCode>W0103080106</emdnCode>
    <emdnDescription>ANTIBODIES FOR LYMPHOCYTE SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6607073</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:38:34.920Z</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>
  <row>
    <udiDi>00382903411122</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>341112</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:42:35.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594208060116</udiDi>
    <basicUdiDi>859420806ED775074</basicUdiDi>
    <tradeName>08594208060116</tradeName>
    <deviceName>DryFlowEx PNH High-Sensitivity Assay Kit</deviceName>
    <manufacturerName>EXBIO Praha, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000033468</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>ED7750</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:46.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594208060055</udiDi>
    <basicUdiDi>859420806ED77367A</basicUdiDi>
    <tradeName>08594208060055</tradeName>
    <deviceName>DryFlowEx TBNK 6-color</deviceName>
    <manufacturerName>EXBIO Praha, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000033468</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>ED7736</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:44.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594208060031</udiDi>
    <basicUdiDi>859420806ED773578</basicUdiDi>
    <tradeName>08594208060031</tradeName>
    <deviceName>KOMBITEST B/NK Cell 4-color</deviceName>
    <manufacturerName>EXBIO Praha, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000033468</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080106</emdnCode>
    <emdnDescription>ANTIBODIES FOR LYMPHOCYTE SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED7735</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:37.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594208060024</udiDi>
    <basicUdiDi>859420806ED773476</basicUdiDi>
    <tradeName>08594208060024</tradeName>
    <deviceName>KOMBITEST T Cell 4-color</deviceName>
    <manufacturerName>EXBIO Praha, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000033468</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080106</emdnCode>
    <emdnDescription>ANTIBODIES FOR LYMPHOCYTE SUBTYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED7734</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:36.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594208060017</udiDi>
    <basicUdiDi>859420806ED773374</basicUdiDi>
    <tradeName>08594208060017</tradeName>
    <deviceName>KOMBITEST TBNK 6-color</deviceName>
    <manufacturerName>EXBIO Praha, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000033468</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>ED7733</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:35.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974501891419</udiDi>
    <basicUdiDi>69745018900C004301WK</basicUdiDi>
    <tradeName>06974501891419</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>W0103080105</emdnCode>
    <emdnDescription>ANTIBODIES FOR SUBTYPING OF LEUKEMIA (EXCEPT B-&amp;T-CELL TYPING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8930086CE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:28:16.303Z</lastUpdated>
  </row>
</eudamedExport>