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<eudamedExport entity="devices">
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    <tradeName>Idylla™ EGFR Mutation Test</tradeName>
    <deviceName>Idylla™ EGFR Mutation Test</deviceName>
    <manufacturerName>Biocartis NV</manufacturerName>
    <manufacturerSrn>BE-MF-000003661</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0270/6</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:53:25.662Z</lastUpdated>
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    <udiDi>05298004820198</udiDi>
    <basicUdiDi>52980048MULTITN</basicUdiDi>
    <tradeName>TarCET Kit Metabolic Panel</tradeName>
    <deviceName>TarCET Kit</deviceName>
    <manufacturerName>MEDICOVER GENETICS LIMITED</manufacturerName>
    <manufacturerSrn>CY-MF-000009381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ET201-00-2016</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:49:42.780Z</lastUpdated>
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    <udiDi>05298004820150</udiDi>
    <basicUdiDi>52980048ULTRAUZ</basicUdiDi>
    <tradeName>UltraVerse Index Oligos (Type A)</tradeName>
    <deviceName>UltraVerse Index Oligos</deviceName>
    <manufacturerName>MEDICOVER GENETICS LIMITED</manufacturerName>
    <manufacturerSrn>CY-MF-000009381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU100-00-100A</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:49:41.989Z</lastUpdated>
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    <udiDi>05298004820075</udiDi>
    <basicUdiDi>52980048PGTZB</basicUdiDi>
    <tradeName>TarCET PGT</tradeName>
    <deviceName>TarCET PGT</deviceName>
    <manufacturerName>MEDICOVER GENETICS LIMITED</manufacturerName>
    <manufacturerSrn>CY-MF-000009381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ET202-00-2016</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:49:37.175Z</lastUpdated>
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    <udiDi>05298004820013</udiDi>
    <basicUdiDi>52980048NIPTTJ</basicUdiDi>
    <tradeName>VERACITY Advance</tradeName>
    <deviceName>VERACITY NIPT Solution</deviceName>
    <manufacturerName>MEDICOVER GENETICS LIMITED</manufacturerName>
    <manufacturerSrn>CY-MF-000009381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010306</emdnCode>
    <emdnDescription>MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV101-00-2096</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:49:36.379Z</lastUpdated>
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    <udiDi>05060536830415</udiDi>
    <basicUdiDi>506053683LIBQ0154</basicUdiDi>
    <tradeName>Library Quantification for Illumina®</tradeName>
    <deviceName>Library Quantification for Illumina®</deviceName>
    <manufacturerName>EntroGen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022721</manufacturerSrn>
    <authorisedRepresentativeName>TANJA TOPOVSEK S.P.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000022518</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LIBQ-NGS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:47:54.831Z</lastUpdated>
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    <udiDi>05060536830262</udiDi>
    <basicUdiDi>506053683IQCA014C</basicUdiDi>
    <tradeName>Internal Quality Control Assay</tradeName>
    <deviceName>Internal Quality Control Assay</deviceName>
    <manufacturerName>EntroGen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022721</manufacturerSrn>
    <authorisedRepresentativeName>TANJA TOPOVSEK S.P.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000022518</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IQCA-RT50</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:47:54.021Z</lastUpdated>
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    <udiDi>05060402680076</udiDi>
    <basicUdiDi>506040268ANM3</basicUdiDi>
    <tradeName>Yourgene® QST*R Base</tradeName>
    <deviceName>Yourgene® QST*R</deviceName>
    <manufacturerName>Yourgene Health UK Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000024810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010306</emdnCode>
    <emdnDescription>MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN0PLB2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:43:11.978Z</lastUpdated>
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    <udiDi>05060402680007</udiDi>
    <basicUdiDi>506040268CFLR</basicUdiDi>
    <tradeName>Yourgene® Cystic Fibrosis Base</tradeName>
    <deviceName>Yourgene® Cystic Fibrosis</deviceName>
    <manufacturerName>Yourgene Health UK Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000024810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CF2EUB2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:43:09.588Z</lastUpdated>
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    <udiDi>05055844906822</udiDi>
    <basicUdiDi>50558449LPH108JL</basicUdiDi>
    <tradeName>IGH/MAF Plus v2 Translocation, Dual Fusion Probe</tradeName>
    <deviceName>IGH/MAF Plus v2 Translocation, Dual Fusion Probe</deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 108</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:29.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906761</udiDi>
    <basicUdiDi>50558449LPH089K9</basicUdiDi>
    <tradeName>CBFB Breakapart Probe</tradeName>
    <deviceName>CBFB Breakapart Probe</deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 089</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:27.763Z</lastUpdated>
  </row>
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    <udiDi>05055844906600</udiDi>
    <basicUdiDi>50558449LPH064JR</basicUdiDi>
    <tradeName>FAST PML/RARα (RARA) Translocation, Dual Fusion Probe</tradeName>
    <deviceName>FAST PML/RARα (RARA) Translocation, Dual Fusion Probe</deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 064</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:27.308Z</lastUpdated>
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  <row>
    <udiDi>05055844906587</udiDi>
    <basicUdiDi>50558449LPH052JJ</basicUdiDi>
    <tradeName>P53 (TP53)/ATM Combination Deletion Probe</tradeName>
    <deviceName>P53 (TP53)/ATM Combination Deletion Probe</deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060201</emdnCode>
    <emdnDescription>P53</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:25.361Z</lastUpdated>
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    <udiDi>05055844906525</udiDi>
    <basicUdiDi>50558449LPH039JS</basicUdiDi>
    <tradeName>CKS1B/CDKN2C (P18) Amplification/Deletion Probe</tradeName>
    <deviceName>CKS1B/CDKN2C (P18) Amplification/Deletion Probe</deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:22.941Z</lastUpdated>
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    <udiDi>05055844906518</udiDi>
    <basicUdiDi>50558449LPH038JQ</basicUdiDi>
    <tradeName>BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe</tradeName>
    <deviceName>BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe</deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 038-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:21.341Z</lastUpdated>
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    <udiDi>05055844906488</udiDi>
    <basicUdiDi>50558449LPH036JL</basicUdiDi>
    <tradeName>EVI1 (MECOM) Breakapart Probe</tradeName>
    <deviceName>EVI1 (MECOM) Breakapart Probe</deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:20.564Z</lastUpdated>
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    <udiDi>05055844906426</udiDi>
    <basicUdiDi>50558449LPH027JK</basicUdiDi>
    <tradeName>AML1 (RUNX1) Breakapart Probe</tradeName>
    <deviceName>AML1 (RUNX1) Breakapart Probe</deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 027</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:18.943Z</lastUpdated>
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    <udiDi>05055844906402</udiDi>
    <basicUdiDi>50558449LPH026JH</basicUdiDi>
    <tradeName>AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion Probe</tradeName>
    <deviceName>AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion Probe</deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 026</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:16.554Z</lastUpdated>
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    <udiDi>05055844906389</udiDi>
    <basicUdiDi>50558449LPH025JF</basicUdiDi>
    <tradeName>Del(7q) Deletion Probe</tradeName>
    <deviceName>Del(7q) Deletion Probe</deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE- LPH 025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:14.947Z</lastUpdated>
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    <udiDi>05055844906365</udiDi>
    <basicUdiDi>50558449LPH024JD</basicUdiDi>
    <tradeName>Del(5q) Deletion Probe</tradeName>
    <deviceName>Del(5q) Deletion Probe</deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:14.155Z</lastUpdated>
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