<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060242470196</udiDi>
    <basicUdiDi>B-05060242470196</basicUdiDi>
    <tradeName>ALBAclone® Anti-Jkb</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>Z166</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:06:42.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242470189</udiDi>
    <basicUdiDi>B-05060242470189</basicUdiDi>
    <tradeName>ALBAclone® Anti-Jka</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>Z162</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:06:40.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242470141</udiDi>
    <basicUdiDi>B-05060242470141</basicUdiDi>
    <tradeName>ALBAclone® Anti-k (cellano)</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>Z137</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:06:39.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Z257K5</udiDi>
    <basicUdiDi>B-Z257K5</basicUdiDi>
    <tradeName>ALBAcheck® - BGS High Titre Control 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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z257</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:14.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750013135</udiDi>
    <basicUdiDi>B-10758750013135</basicUdiDi>
    <tradeName>ORTHO™ Sera 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:52:30.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750013159</udiDi>
    <basicUdiDi>B-10758750013159</basicUdiDi>
    <tradeName>ORTHO™ Sera Anti-Jka</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:52:30.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750013173</udiDi>
    <basicUdiDi>B-10758750013173</basicUdiDi>
    <tradeName>ORTHO™ Anti-S</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:52:30.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750013180</udiDi>
    <basicUdiDi>B-10758750013180</basicUdiDi>
    <tradeName>ORTHO™ Anti-s</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:52:30.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750013203</udiDi>
    <basicUdiDi>B-10758750013203</basicUdiDi>
    <tradeName>ORTHO™ Sera Anti-K</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:52:30.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750013210</udiDi>
    <basicUdiDi>B-10758750013210</basicUdiDi>
    <tradeName>ORTHO™ Sera Anti-M</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:52:30.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750013227</udiDi>
    <basicUdiDi>B-10758750013227</basicUdiDi>
    <tradeName>ORTHO™ Anti-N</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:52:30.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750013234</udiDi>
    <basicUdiDi>B-10758750013234</basicUdiDi>
    <tradeName>ORTHO™ Anti-Lea</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:52:30.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750013258</udiDi>
    <basicUdiDi>B-10758750013258</basicUdiDi>
    <tradeName>ORTHO™ Anti-P1</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T13:52:30.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750031566</udiDi>
    <basicUdiDi>B-10758750031566</basicUdiDi>
    <tradeName>ORTHO™ Sera Reagent Control</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T02:37:16.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750012862</udiDi>
    <basicUdiDi>B-10758750012862</basicUdiDi>
    <tradeName>ORTHO CONFIDENCE™</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T22:36:43.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750013197</udiDi>
    <basicUdiDi>B-10758750013197</basicUdiDi>
    <tradeName>ORTHO™ Sera Anti-D (IAT)</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T22:36:43.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750030170</udiDi>
    <basicUdiDi>B-10758750030170</basicUdiDi>
    <tradeName>ORTHO™ Sera Anti-D (DVI)</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T22:36:43.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750013241</udiDi>
    <basicUdiDi>B-10758750013241</basicUdiDi>
    <tradeName>ORTHO™ Anti-Leb</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></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:29:41.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750013166</udiDi>
    <basicUdiDi>B-10758750013166</basicUdiDi>
    <tradeName>ORTHO™ Sera Anti-Jkb</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></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:29:40.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>10758750013142</udiDi>
    <basicUdiDi>B-10758750013142</basicUdiDi>
    <tradeName>ORTHO™ Sera 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></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:29:39.025Z</lastUpdated>
  </row>
</eudamedExport>