<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08718469369317</udiDi>
    <basicUdiDi>871846936ngsgo-ampxv2F4</basicUdiDi>
    <tradeName>NGSgo®-AmpX v2 HLA-DRB1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030499</emdnCode>
    <emdnDescription>TISSUE TYPING REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7970662</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:29:47.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>08718469369324</udiDi>
    <basicUdiDi>871846936ngsgo-ampxv2F4</basicUdiDi>
    <tradeName>NGSgo®-AmpX v2 HLA-DRB3/4/5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030499</emdnCode>
    <emdnDescription>TISSUE TYPING REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7970762</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:29:47.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>08718469369331</udiDi>
    <basicUdiDi>871846936ngsgo-ampxv2F4</basicUdiDi>
    <tradeName>NGSgo®-AmpX v2 HLA-DQB1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030499</emdnCode>
    <emdnDescription>TISSUE TYPING REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7970562</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:29:47.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>08718469369348</udiDi>
    <basicUdiDi>871846936ngsgo-ampxv2F4</basicUdiDi>
    <tradeName>NGSgo®-AmpX v2 HLA-DPB1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030499</emdnCode>
    <emdnDescription>TISSUE TYPING REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7970462</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:29:47.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>08718469369355</udiDi>
    <basicUdiDi>871846936ngsgo-ampxv2F4</basicUdiDi>
    <tradeName>NGSgo®-AmpX v2 HLA-DQA1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030499</emdnCode>
    <emdnDescription>TISSUE TYPING REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7970862</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:29:47.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>08718469369362</udiDi>
    <basicUdiDi>871846936ngsgo-ampxv2F4</basicUdiDi>
    <tradeName>NGSgo®-AmpX v2 HLA-DPA1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030499</emdnCode>
    <emdnDescription>TISSUE TYPING REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7970962</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:29:47.731Z</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>10888234500407</udiDi>
    <basicUdiDi>88823411W01030402C006BJS</basicUdiDi>
    <tradeName>Concentrated Wash</tradeName>
    <deviceName>Concentrated Wash</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>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403622</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:20:46.056Z</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>10888234400516</udiDi>
    <basicUdiDi>88823411W01030402C002HJS</basicUdiDi>
    <tradeName>LIFECODES Wash Buffer</tradeName>
    <deviceName>LIFECODES Wash Buffer</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>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>628211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:50.689Z</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>06976241370025</udiDi>
    <basicUdiDi>697624137002K3</basicUdiDi>
    <tradeName>SeekMate Tissue Dissociation Kit</tradeName>
    <deviceName>SeekMate Tissue Dissociation Kit</deviceName>
    <manufacturerName>Beijing SeekGene BioSciences Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000034144</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030499</emdnCode>
    <emdnDescription>TISSUE TYPING REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30 tests</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:54:05.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976241370018</udiDi>
    <basicUdiDi>697624137001JZ</basicUdiDi>
    <tradeName>SeekMate Tissue Dissociation Kit</tradeName>
    <deviceName>SeekMate Tissue Dissociation Kit</deviceName>
    <manufacturerName>Beijing SeekGene BioSciences Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000034144</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030499</emdnCode>
    <emdnDescription>TISSUE TYPING REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8 tests</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:54:01.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>03366160500482</udiDi>
    <basicUdiDi>3661605CMSMSLV7</basicUdiDi>
    <tradeName>Milieu de séparation des lymphocytes</tradeName>
    <deviceName>Milieu de séparation des lymphocytes</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030405</emdnCode>
    <emdnDescription>LYMPHOCYTE SEPARATION MEDIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMSMSL01-0U</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T10:22:42.977Z</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>