<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07340035526049</udiDi>
    <basicUdiDi>73400355ASTXLU</basicUdiDi>
    <tradeName>07340035526049</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>404.091-96</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:35:50.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035526032</udiDi>
    <basicUdiDi>73400355ASTXLU</basicUdiDi>
    <tradeName>07340035526032</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>404.172-96</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:35:49.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035526025</udiDi>
    <basicUdiDi>73400355ASTXLU</basicUdiDi>
    <tradeName>07340035526025</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>404.171-96</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:35:47.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035526018</udiDi>
    <basicUdiDi>73400355ASTXLU</basicUdiDi>
    <tradeName>07340035526018</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>404.172-24</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:35:41.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035526001</udiDi>
    <basicUdiDi>73400355ASTXLU</basicUdiDi>
    <tradeName>07340035526001</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>404.171-24</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:35:40.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035525066</udiDi>
    <basicUdiDi>73400355QTYPE11TL</basicUdiDi>
    <tradeName>07340035525066</tradeName>
    <deviceName>QTYPE</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>201.701-03</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:35:39.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035525059</udiDi>
    <basicUdiDi>73400355QTYPE11TL</basicUdiDi>
    <tradeName>07340035525059</tradeName>
    <deviceName>QTYPE</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>201.701-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:35:38.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>10888234100812</udiDi>
    <basicUdiDi>88823412W01030403C00000YJ</basicUdiDi>
    <tradeName>MIA FORA NGS MFlex 6 HLA Typing Kit, 24 test</tradeName>
    <deviceName></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-800-10535-24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:13:45.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>10888234100829</udiDi>
    <basicUdiDi>88823412W01030403C00000YJ</basicUdiDi>
    <tradeName>MIA FORA NGS MFlex 11 HLA Typing Kit, 96 test</tradeName>
    <deviceName></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-800-10534-96</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:13:45.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>10888234100843</udiDi>
    <basicUdiDi>88823412W01030403C00000YJ</basicUdiDi>
    <tradeName>MIA FORA NGS MFlex 6 HLA Typing Kit, 96 test</tradeName>
    <deviceName></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-800-10535-96</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:13:45.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>10888234100850</udiDi>
    <basicUdiDi>88823412W01030403C00000YJ</basicUdiDi>
    <tradeName>MIA FORA NGS MFlex 11 HT HLA Typing Kit</tradeName>
    <deviceName></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-800-10534-1152</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:13:45.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>10888234100867</udiDi>
    <basicUdiDi>88823412W01030403C00000YJ</basicUdiDi>
    <tradeName>MIA FORA NGS MFlex 6 HT HLA Typing Kit</tradeName>
    <deviceName></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-800-10535-1152</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:13:45.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>10888234102441</udiDi>
    <basicUdiDi>88823412W01030403C00000YJ</basicUdiDi>
    <tradeName>MIA FORA NGS Software (LINUX)</tradeName>
    <deviceName></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-850-00043</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:13:45.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695022823</udiDi>
    <basicUdiDi>081469502SECGZ</basicUdiDi>
    <tradeName>SeCore™ A Locus Sequencing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22000D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695022830</udiDi>
    <basicUdiDi>081469502SECGZ</basicUdiDi>
    <tradeName>SeCore™ B Locus Sequencing Kit, Single Amplification</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22110D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695022854</udiDi>
    <basicUdiDi>081469502SECGZ</basicUdiDi>
    <tradeName>SeCore™ B Locus Sequencing Kit, Single Amplification</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5311025D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025268</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-ABCDRDQB1 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1054C-RLC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025299</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-ABCDRDQA1DQB1 384 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1550C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025312</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-ABCDRDQB1 384 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1551C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025336</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-ABCDRDQB1 384 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1554C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.435Z</lastUpdated>
  </row>
</eudamedExport>