<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060242472251</udiDi>
    <basicUdiDi>B-05060242472251</basicUdiDi>
    <tradeName>Polyspecific Anti-Human Globulin Reagent</tradeName>
    <deviceName>Polyspecific Anti-Human Globulin Reagent</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030304</emdnCode>
    <emdnDescription>POLYSPECIFIC ANTIHUMAN SERUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z350</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:35.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472244</udiDi>
    <basicUdiDi>B-05060242472244</basicUdiDi>
    <tradeName>ALBAclone® Anti-Fyb</tradeName>
    <deviceName>ALBAclone® Anti-Fyb</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z154</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:35.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472220</udiDi>
    <basicUdiDi>B-05060242472220</basicUdiDi>
    <tradeName>ALBAcyte® Reagent Red Cells B</tradeName>
    <deviceName>ALBAcyte® Reagent Red Cells B</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030101</emdnCode>
    <emdnDescription>ABO GROUPING CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z411</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:33.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472206</udiDi>
    <basicUdiDi>B-05060242472206</basicUdiDi>
    <tradeName>ALBAcyte® Reagent Red Cells A1</tradeName>
    <deviceName>ALBAcyte® Reagent Red Cells A1</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030101</emdnCode>
    <emdnDescription>ABO GROUPING CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z401</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:31.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472183</udiDi>
    <basicUdiDi>B-05060242472183</basicUdiDi>
    <tradeName>ALBAcyte® IgG Sensitised Reagent Red Cells</tradeName>
    <deviceName>ALBAcyte® IgG Sensitised Reagent Red Cells</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030401</emdnCode>
    <emdnDescription>COOMBS CONTROL CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z441</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:29.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472176</udiDi>
    <basicUdiDi>B-05060242472176</basicUdiDi>
    <tradeName>ALBAcyte® Reagent Red Cells O rr</tradeName>
    <deviceName>ALBAcyte® Reagent Red Cells O rr</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z421</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:28.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472169</udiDi>
    <basicUdiDi>B-05060242472169</basicUdiDi>
    <tradeName>ALBAcyte® Reagent Red Cells O R1r</tradeName>
    <deviceName>ALBAcyte® Reagent Red Cells O R1r</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z416</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:27.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472152</udiDi>
    <basicUdiDi>B-05060242472152</basicUdiDi>
    <tradeName>ALBAcyte® Reagent Red Cells A2</tradeName>
    <deviceName>ALBAcyte® Reagent Red Cells A2</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030101</emdnCode>
    <emdnDescription>ABO GROUPING CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z406</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:23.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472145</udiDi>
    <basicUdiDi>B-05060242472145</basicUdiDi>
    <tradeName>ALBAcheck® - BGS AB Serum (Human)</tradeName>
    <deviceName>ALBAcheck® - BGS AB Serum (Human)</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z281</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:22.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472138</udiDi>
    <basicUdiDi>B-05060242472138</basicUdiDi>
    <tradeName>ALBAcheck® - BGS Reagent Control for Anti-D</tradeName>
    <deviceName>ALBAcheck® - BGS Reagent Control for Anti-D</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z271</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:21.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472121</udiDi>
    <basicUdiDi>B-05060242472121</basicUdiDi>
    <tradeName>ALBAcheck® - BGS Anti-D 0.05 IU/mL</tradeName>
    <deviceName>ALBAcheck® - BGS Anti-D 0.05 IU/mL</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z263</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:19.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472114</udiDi>
    <basicUdiDi>B-05060242472114</basicUdiDi>
    <tradeName>ALBAcheck® - BGS Anti-D &lt;0.1 IU/mL</tradeName>
    <deviceName>ALBAcheck® - BGS Anti-D &lt;0.1 IU/mL</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z262</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:17.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242471995</udiDi>
    <basicUdiDi>B-05060242471995</basicUdiDi>
    <tradeName>ALBAclone® Anti-c</tradeName>
    <deviceName>ALBAclone® Anti-c</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030202</emdnCode>
    <emdnDescription>RHESUS PHENOTYPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z083</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:15.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242471988</udiDi>
    <basicUdiDi>B-05060242471988</basicUdiDi>
    <tradeName>ALBAclone® Anti-E</tradeName>
    <deviceName>ALBAclone® Anti-E</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030202</emdnCode>
    <emdnDescription>RHESUS PHENOTYPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z073</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:15.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242471964</udiDi>
    <basicUdiDi>B-05060242471964</basicUdiDi>
    <tradeName>ALBAclone® Anti-D blend Monoclonal IgM/IgG</tradeName>
    <deviceName>ALBAclone® Anti-D blend</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030201</emdnCode>
    <emdnDescription>RHESUS D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z041</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:13.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242471957</udiDi>
    <basicUdiDi>B-05060242471957</basicUdiDi>
    <tradeName>ALBAclone® Anti-D optimum</tradeName>
    <deviceName>ALBAclone® Anti-D optimum</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030201</emdnCode>
    <emdnDescription>RHESUS D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z039</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:11.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242471933</udiDi>
    <basicUdiDi>B-05060242471933</basicUdiDi>
    <tradeName>ALBAclone® Anti-D alpha</tradeName>
    <deviceName>ALBAclone® Anti-D alpha</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030201</emdnCode>
    <emdnDescription>RHESUS D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z031</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:09.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242471926</udiDi>
    <basicUdiDi>B-05060242471926</basicUdiDi>
    <tradeName>ALBAclone® Anti-A,B</tradeName>
    <deviceName>ALBAclone® Anti-A,B</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030102</emdnCode>
    <emdnDescription>ABO SERA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z021</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:08.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242471919</udiDi>
    <basicUdiDi>B-05060242471919</basicUdiDi>
    <tradeName>ALBAclone® Anti-B</tradeName>
    <deviceName>ALBAclone® Anti-B</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030102</emdnCode>
    <emdnDescription>ABO SERA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z011</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:07.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242471902</udiDi>
    <basicUdiDi>B-05060242471902</basicUdiDi>
    <tradeName>ALBAclone® Anti-A</tradeName>
    <deviceName>ALBAclone® Anti-A</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030102</emdnCode>
    <emdnDescription>ABO SERA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:17:05.355Z</lastUpdated>
  </row>
</eudamedExport>