<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850081948636</udiDi>
    <basicUdiDi>08500819481PAJ</basicUdiDi>
    <tradeName>MIA FORA NGS MFlex 11 HT HLA Typing Kit</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-800-10534-1152</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:31:35.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025251</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-ABCDRDQB1 Typing Kit</tradeName>
    <deviceName>LinkSēq™ HLA Typing Kits</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-ABS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:18:09.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695021697</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>5300025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:18:06.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812117011042</udiDi>
    <basicUdiDi>081211701SSOAZ</basicUdiDi>
    <tradeName>LABType™ SSO Typing Test</tradeName>
    <deviceName>LABType™ SSO Class I A Locus Typing Test</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>RSSO1A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:24.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>+G2860150-</udiDi>
    <basicUdiDi>++G286HSeqDPBMG</basicUdiDi>
    <tradeName>H-Seq-DPB Sequenzierungskit für 48 Typisierungen</tradeName>
    <deviceName>H-Seq-DPB Sequenzierungskit für 48 Typisierungen</deviceName>
    <manufacturerName>Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018980</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>015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:22:52.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>+G2860080_</udiDi>
    <basicUdiDi>++G286HSeqDQBMK</basicUdiDi>
    <tradeName>H-Seq-DQB Sequenzierungskit für 48 Typisierungen</tradeName>
    <deviceName>H-Seq-DQB Sequenzierungskit für 48 Typisierungen</deviceName>
    <manufacturerName>Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018980</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>008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:22:50.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>+G2860030X</udiDi>
    <basicUdiDi>++G286HSeqDRHH</basicUdiDi>
    <tradeName>H-Seq-DR Sequenzierungskit für 48Typisierungen</tradeName>
    <deviceName>H-Seq-DR Sequenzierungskit für 48 Typisierungen</deviceName>
    <manufacturerName>Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018980</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>002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:22:48.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850081948742</udiDi>
    <basicUdiDi>08500819481PAJ</basicUdiDi>
    <tradeName>MIA FORA NGS MFlex 11 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-800-10534-24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:24.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850081948759</udiDi>
    <basicUdiDi>08500819481PAJ</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>2026-07-13T19:55:22.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850081948643</udiDi>
    <basicUdiDi>08500819481PAJ</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>2026-07-13T19:55:14.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850081948667</udiDi>
    <basicUdiDi>08500819481PAJ</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>2026-07-13T19:55:13.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850081948650</udiDi>
    <basicUdiDi>08500819481PAJ</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>2026-07-13T19:55:12.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850081948674</udiDi>
    <basicUdiDi>08500819481PAJ</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>2026-07-13T19:55:12.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>19358706000069</udiDi>
    <basicUdiDi>B-19358706000069</basicUdiDi>
    <tradeName>19358706000069</tradeName>
    <deviceName>AlloSeq Tx 9</deviceName>
    <manufacturerName>CareDx Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000046711</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASTX9.1(96)-B-IVD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:11:58.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>19358706000052</udiDi>
    <basicUdiDi>B-19358706000052</basicUdiDi>
    <tradeName>19358706000052</tradeName>
    <deviceName>AlloSeq Tx 9</deviceName>
    <manufacturerName>CareDx Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000046711</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASTX9.1(96)-A-IVD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:11:58.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>19358706000045</udiDi>
    <basicUdiDi>B-19358706000045</basicUdiDi>
    <tradeName>19358706000045</tradeName>
    <deviceName>AlloSeq Tx 17</deviceName>
    <manufacturerName>CareDx Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000046711</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASTX17.1(96)-B-IVD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:11:57.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>19358706000038</udiDi>
    <basicUdiDi>B-19358706000038</basicUdiDi>
    <tradeName>19358706000038</tradeName>
    <deviceName>AlloSeq Tx 17</deviceName>
    <manufacturerName>CareDx Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000046711</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASTX17.1(96)-A-IVD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:11:53.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>19358706000021</udiDi>
    <basicUdiDi>B-19358706000021</basicUdiDi>
    <tradeName>19358706000021</tradeName>
    <deviceName>AlloSeq Tx 17</deviceName>
    <manufacturerName>CareDx Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000046711</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASTX17.1(24)-B-IVD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:11:52.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>19358706000014</udiDi>
    <basicUdiDi>B-19358706000014</basicUdiDi>
    <tradeName>19358706000014</tradeName>
    <deviceName>AlloSeq Tx 17</deviceName>
    <manufacturerName>CareDx Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000046711</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASTX17.1(24)-IVD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:11:52.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035525035</udiDi>
    <basicUdiDi>B-07340035525035</basicUdiDi>
    <tradeName>07340035525035</tradeName>
    <deviceName>Olerup QTYPE LC480 II Cal Plate</deviceName>
    <manufacturerName>CareDx AB</manufacturerName>
    <manufacturerSrn>SE-MF-000040995</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030403</emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>203.501-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:12:13.095Z</lastUpdated>
  </row>
</eudamedExport>