<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07340035500223</udiDi>
    <basicUdiDi>B-07340035500223</basicUdiDi>
    <tradeName>07340035500223</tradeName>
    <deviceName>SSP DRB1*04</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101.114-24u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:43.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035500209</udiDi>
    <basicUdiDi>B-07340035500209</basicUdiDi>
    <tradeName>07340035500209</tradeName>
    <deviceName>SSP DRB1*03</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101.113-04u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:42.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035500186</udiDi>
    <basicUdiDi>B-07340035500186</basicUdiDi>
    <tradeName>07340035500186</tradeName>
    <deviceName>SSP DRB1*03</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101.113-24u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:41.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035500162</udiDi>
    <basicUdiDi>B-07340035500162</basicUdiDi>
    <tradeName>07340035500162</tradeName>
    <deviceName>SSP DRB1*16</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101.126-12u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:40.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035500148</udiDi>
    <basicUdiDi>B-07340035500148</basicUdiDi>
    <tradeName>07340035500148</tradeName>
    <deviceName>SSP DRB1*15</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101.125-06u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:36.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035500124</udiDi>
    <basicUdiDi>B-07340035500124</basicUdiDi>
    <tradeName>07340035500124</tradeName>
    <deviceName>SSP DRB1*15</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101.125-24u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:35.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035500100</udiDi>
    <basicUdiDi>B-07340035500100</basicUdiDi>
    <tradeName>07340035500100</tradeName>
    <deviceName>SSP DRB1*01</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101.111-06u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:34.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035500087</udiDi>
    <basicUdiDi>B-07340035500087</basicUdiDi>
    <tradeName>07340035500087</tradeName>
    <deviceName>SSP DRB1*01</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101.111-24u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:33.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035500049</udiDi>
    <basicUdiDi>B-07340035500049</basicUdiDi>
    <tradeName>07340035500049</tradeName>
    <deviceName>SSP DR low</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101.101-12u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:30.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035500025</udiDi>
    <basicUdiDi>B-07340035500025</basicUdiDi>
    <tradeName>07340035500025</tradeName>
    <deviceName>SSP DR low</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101.101-48u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:29.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760369290371</udiDi>
    <basicUdiDi>B-03760369290371</basicUdiDi>
    <tradeName>Trousse NG-Mix Multiloci</tradeName>
    <deviceName>Trousse NG-Mix Multiloci pour le génotypage des allèles HLA en haute résolution par la méthode Nouvelle Génération de Séquençage (NGS)</deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>265857</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:19:44.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>10888234500827</udiDi>
    <basicUdiDi>88823411W01030403C004JKH</basicUdiDi>
    <tradeName>Dilution Solution</tradeName>
    <deviceName>Dilution Solution</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000020921</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>628515UDI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:46.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>10888234400677</udiDi>
    <basicUdiDi>88823411W01030403C004KKK</basicUdiDi>
    <tradeName>Streptavidin-PE</tradeName>
    <deviceName>Streptavidin-PE</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000020921</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>628511</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:42.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>10888234400448</udiDi>
    <basicUdiDi>88823411W01030403C004LKM</basicUdiDi>
    <tradeName>Nuclease-Free Water</tradeName>
    <deviceName>Nuclease-Free Water</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000020921</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>757003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:41.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>10888234400134</udiDi>
    <basicUdiDi>88823411W01030403C004IKF</basicUdiDi>
    <tradeName>LIFECODES Taq Polymerase</tradeName>
    <deviceName>LIFECODES Taq Polymerase</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000020921</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>628075</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:40.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>10888234100805</udiDi>
    <basicUdiDi>88823412W01030403C00000YJ</basicUdiDi>
    <tradeName>MIA FORA NGS MFlex 11 HLA Typing Kit, 24 test</tradeName>
    <deviceName>MIA FORA NGS MFlex HLA Typing Kit &amp; Software</deviceName>
    <manufacturerName>BioArray Solutions Ltd</manufacturerName>
    <manufacturerSrn>US-MF-000022068</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR-800-10534-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:39.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035525073</udiDi>
    <basicUdiDi>73400355QTYPECCW9</basicUdiDi>
    <tradeName>07340035525073</tradeName>
    <deviceName>QTYPE Colour Compensation Plate</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>203.501-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:37:14.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035526148</udiDi>
    <basicUdiDi>73400355ASTXLU</basicUdiDi>
    <tradeName>07340035526148</tradeName>
    <deviceName>AlloSeq Tx</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404.112-96</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:35:58.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035526124</udiDi>
    <basicUdiDi>73400355ASTXLU</basicUdiDi>
    <tradeName>07340035526124</tradeName>
    <deviceName>AlloSeq Tx</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404.111-96</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:35:57.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035526056</udiDi>
    <basicUdiDi>73400355ASTXLU</basicUdiDi>
    <tradeName>07340035526056</tradeName>
    <deviceName>AlloSeq Tx</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404.092-96</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:35:51.438Z</lastUpdated>
  </row>
</eudamedExport>