<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08684387215473</udiDi>
    <basicUdiDi>B-08684387215473</basicUdiDi>
    <tradeName>RevoDx HLA B27 Direct qPCR Kit (Extraction-free)</tradeName>
    <deviceName>RevoDx HLA B27 Direct qPCR Kit (Extraction-free)</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030499</emdnCode>
    <emdnDescription>TISSUE TYPING REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202425-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:05:05.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215466</udiDi>
    <basicUdiDi>B-08684387215466</basicUdiDi>
    <tradeName>RevoDx HLA B27 Direct qPCR Kit (Extraction-free)</tradeName>
    <deviceName>RevoDx HLA B27 Direct qPCR Kit (Extraction-free)</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030499</emdnCode>
    <emdnDescription>TISSUE TYPING REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202425-50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:05:04.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215435</udiDi>
    <basicUdiDi>B-08684387215435</basicUdiDi>
    <tradeName>RevoDx HLA B27 qPCR Kit</tradeName>
    <deviceName>RevoDx HLA B27 qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030499</emdnCode>
    <emdnDescription>TISSUE TYPING REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202410-500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:04:58.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215428</udiDi>
    <basicUdiDi>B-08684387215428</basicUdiDi>
    <tradeName>RevoDx HLA B27 qPCR Kit</tradeName>
    <deviceName>RevoDx HLA B27 qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030499</emdnCode>
    <emdnDescription>TISSUE TYPING REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202410-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:04:57.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215411</udiDi>
    <basicUdiDi>B-08684387215411</basicUdiDi>
    <tradeName>RevoDx HLA B27 qPCR Kit</tradeName>
    <deviceName>RevoDx HLA B27 qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030499</emdnCode>
    <emdnDescription>TISSUE TYPING REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202410-50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:04:56.867Z</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>
  <row>
    <udiDi>07340035525011</udiDi>
    <basicUdiDi>B-07340035525011</basicUdiDi>
    <tradeName>07340035525011</tradeName>
    <deviceName>Olerup QTYPE 11</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>201.701-03</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:12:12.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035525004</udiDi>
    <basicUdiDi>B-07340035525004</basicUdiDi>
    <tradeName>07340035525004</tradeName>
    <deviceName>Olerup QTYPE 11</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>201.701-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:12:10.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035508083</udiDi>
    <basicUdiDi>B-07340035508083</basicUdiDi>
    <tradeName>07340035508083</tradeName>
    <deviceName>SSP KIR Ligand</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>104.201-12u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:12:06.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035508069</udiDi>
    <basicUdiDi>B-07340035508069</basicUdiDi>
    <tradeName>07340035508069</tradeName>
    <deviceName>SSP KIR Genotyping</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>104.101-12u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:12:05.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035508021</udiDi>
    <basicUdiDi>B-07340035508021</basicUdiDi>
    <tradeName>07340035508021</tradeName>
    <deviceName>HLA Wipe Test</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>102.101-01u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:12:04.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035507147</udiDi>
    <basicUdiDi>B-07340035507147</basicUdiDi>
    <tradeName>07340035507147</tradeName>
    <deviceName>SSP A-B-DR-DQ</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>101.708-24u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:12:01.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035507109</udiDi>
    <basicUdiDi>B-07340035507109</basicUdiDi>
    <tradeName>07340035507109</tradeName>
    <deviceName>SSP DQ-DR</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>101.704-48u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:12:00.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035507086</udiDi>
    <basicUdiDi>B-07340035507086</basicUdiDi>
    <tradeName>07340035507086</tradeName>
    <deviceName>SSP A-B-C</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>101.702-06u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:11:59.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035507123</udiDi>
    <basicUdiDi>B-07340035507123</basicUdiDi>
    <tradeName>07340035507123</tradeName>
    <deviceName>SSP DQ-DR</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>101.704-12u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:11:57.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035507062</udiDi>
    <basicUdiDi>B-07340035507062</basicUdiDi>
    <tradeName>07340035507062</tradeName>
    <deviceName>SSP A-B-C</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>101.702-24u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:11:55.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035507048</udiDi>
    <basicUdiDi>B-07340035507048</basicUdiDi>
    <tradeName>07340035507048</tradeName>
    <deviceName>SSP A-B-DR</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>101.701-06u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:11:40.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035507024</udiDi>
    <basicUdiDi>B-07340035507024</basicUdiDi>
    <tradeName>07340035507024</tradeName>
    <deviceName>SSP A-B-DR</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>101.701-24u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:11:39.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035506522</udiDi>
    <basicUdiDi>B-07340035506522</basicUdiDi>
    <tradeName>07340035506522</tradeName>
    <deviceName>SSP HLA-C low Screening</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>101.603-12u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:11:38.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340035506508</udiDi>
    <basicUdiDi>B-07340035506508</basicUdiDi>
    <tradeName>07340035506508</tradeName>
    <deviceName>SSP HLA-C low Screening</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>101.603-24u</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:11:37.799Z</lastUpdated>
  </row>
</eudamedExport>