<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060242470622</udiDi>
    <basicUdiDi>B-05060242470622</basicUdiDi>
    <tradeName>ALBAclone® Anti-human C3</tradeName>
    <deviceName>ALBAclone® Anti-Human C3</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z360</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:23:59.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472602</udiDi>
    <basicUdiDi>0506024247FD313BAQ</basicUdiDi>
    <tradeName>ORTHOTM Elution Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6324445</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:42.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472299</udiDi>
    <basicUdiDi>B-05060242472299</basicUdiDi>
    <tradeName>ALBAclone® Anti-Fya</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z152</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:41.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472275</udiDi>
    <basicUdiDi>B-05060242472275</basicUdiDi>
    <tradeName>Anti-A1 LECTIN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z241</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:40.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472268</udiDi>
    <basicUdiDi>B-05060242472268</basicUdiDi>
    <tradeName>Monospecific Anti-Human IgG</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030305</emdnCode>
    <emdnDescription>MONOSPECIFIC ANTIHUMAN SERUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z356</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:39.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472251</udiDi>
    <basicUdiDi>B-05060242472251</basicUdiDi>
    <tradeName>Polyspecific Anti-Human Globulin Reagent</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030304</emdnCode>
    <emdnDescription>POLYSPECIFIC ANTIHUMAN SERUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z350</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:37.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472244</udiDi>
    <basicUdiDi>B-05060242472244</basicUdiDi>
    <tradeName>ALBAclone® Anti-Fyb</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z154</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:36.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472220</udiDi>
    <basicUdiDi>B-05060242472220</basicUdiDi>
    <tradeName>ALBAcyte® Reagent Red Cells B</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030101</emdnCode>
    <emdnDescription>ABO GROUPING CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z411</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:34.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472206</udiDi>
    <basicUdiDi>B-05060242472206</basicUdiDi>
    <tradeName>ALBAcyte® Reagent Red Cells A1</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030101</emdnCode>
    <emdnDescription>ABO GROUPING CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z401</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:33.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472183</udiDi>
    <basicUdiDi>B-05060242472183</basicUdiDi>
    <tradeName>ALBAcyte® IgG Sensitised Reagent Red Cells</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030401</emdnCode>
    <emdnDescription>COOMBS CONTROL CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z441</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:31.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472176</udiDi>
    <basicUdiDi>B-05060242472176</basicUdiDi>
    <tradeName>ALBAcyte® Reagent Red Cells O rr</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z421</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:31.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472169</udiDi>
    <basicUdiDi>B-05060242472169</basicUdiDi>
    <tradeName>ALBAcyte® Reagent Red Cells O R1r</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z416</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:29.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472152</udiDi>
    <basicUdiDi>B-05060242472152</basicUdiDi>
    <tradeName>ALBAcyte® Reagent Red Cells A2</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030101</emdnCode>
    <emdnDescription>ABO GROUPING CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z406</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:28.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472145</udiDi>
    <basicUdiDi>B-05060242472145</basicUdiDi>
    <tradeName>ALBAcheck® - BGS AB Serum (Human)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z281</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:26.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472138</udiDi>
    <basicUdiDi>B-05060242472138</basicUdiDi>
    <tradeName>ALBAcheck® - BGS Reagent Control for Anti-D</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z271</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:25.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472121</udiDi>
    <basicUdiDi>B-05060242472121</basicUdiDi>
    <tradeName>ALBAcheck® - BGS Anti-D 0.05 IU/mL</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z263</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:23.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242472114</udiDi>
    <basicUdiDi>B-05060242472114</basicUdiDi>
    <tradeName>ALBAcheck® - BGS Anti-D &lt;0.1 IU/mL</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z262</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:22.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242471995</udiDi>
    <basicUdiDi>B-05060242471995</basicUdiDi>
    <tradeName>ALBAclone® Anti-c</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030202</emdnCode>
    <emdnDescription>RHESUS PHENOTYPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z083</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:21.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242471988</udiDi>
    <basicUdiDi>B-05060242471988</basicUdiDi>
    <tradeName>ALBAclone® Anti-E</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030202</emdnCode>
    <emdnDescription>RHESUS PHENOTYPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z073</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:20.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242471964</udiDi>
    <basicUdiDi>B-05060242471964</basicUdiDi>
    <tradeName>ALBAclone® Anti-D blend Monoclonal IgM/IgG</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103030201</emdnCode>
    <emdnDescription>RHESUS D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z041</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:07:18.443Z</lastUpdated>
  </row>
</eudamedExport>