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<eudamedExport entity="devices">
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    <udiDi>00810022732557</udiDi>
    <basicUdiDi>081002273K41204314J</basicUdiDi>
    <tradeName>LeukoStrat CDx FLT3 Mutation Assay</tradeName>
    <deviceName>LeukoStrat CDx FLT3 Mutation Assay</deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000003774</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>Artık piyasada değil</deviceStatus>
    <reference>K4120431</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:50:37.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810022732595</udiDi>
    <basicUdiDi>081002273K41204314J</basicUdiDi>
    <tradeName>LeukoStrat CDx FLT3 Mutation Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000003774</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K4120431</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:00:43.684Z</lastUpdated>
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  <row>
    <udiDi>D-A071D6</udiDi>
    <basicUdiDi>B-A071D6</basicUdiDi>
    <tradeName>D-A071D6</tradeName>
    <deviceName>PHASIFY™ Endometrial Cancer Subtyping Kit</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHASIFY™ Endometrial Cancer Subtyping Kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-24T15:17:47.372Z</lastUpdated>
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  <row>
    <udiDi>15415219000550</udiDi>
    <basicUdiDi>B-15415219000550</basicUdiDi>
    <tradeName>Idylla™ MSI Test</tradeName>
    <deviceName>Idylla™ MSI Test</deviceName>
    <manufacturerName>Biocartis NV</manufacturerName>
    <manufacturerSrn>BE-MF-000003661</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0100/6</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:36:13.088Z</lastUpdated>
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  <row>
    <udiDi>D-A070D4</udiDi>
    <basicUdiDi>B-A070D4</basicUdiDi>
    <tradeName>D-A070D4</tradeName>
    <deviceName>PHASIFY™ Endometrial Cancer Methylation Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHASIFY™ Endometrial Cancer Methylation Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:26.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A068DH</udiDi>
    <basicUdiDi>B-A068DH</basicUdiDi>
    <tradeName>D-A068DH</tradeName>
    <deviceName>PHASIFY™ HPV PCR Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHASIFY™ HPV PCR Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:24.649Z</lastUpdated>
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  <row>
    <udiDi>D-A069DK</udiDi>
    <basicUdiDi>B-A069DK</basicUdiDi>
    <tradeName>D-A069DK</tradeName>
    <deviceName>PHASIFY™ ASCL1,LHX8 and SOX1 Genetic methylation PCR Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHASIFY™ ASCL1,LHX8 and SOX1 Genetic methylation PCR Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:24.567Z</lastUpdated>
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  <row>
    <udiDi>D-5713915SS014VCRK</udiDi>
    <basicUdiDi>B-5713915SS014VCRK</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® Liquid KIT qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5800; 5581</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:49:02.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5713915SS013VARA</udiDi>
    <basicUdiDi>B-5713915SS013VARA</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE KIT qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1154; 1846</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:49:01.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5713915SS010V4Q3</udiDi>
    <basicUdiDi>B-5713915SS010V4Q3</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® Liquid PIK3CA qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5585; 5586; 5587; 5590; 5591; 5592; 5600; 5601</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:49:01.366Z</lastUpdated>
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  <row>
    <udiDi>D-5713915SS007VFRZ</udiDi>
    <basicUdiDi>B-5713915SS007VFRZ</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE NRAS qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1771;-76,-81,86,96;1801,-11,-16,-21,-26;2000,-05,-10,-15,-25,-30,-40,-45,-50,-55</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:57.556Z</lastUpdated>
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  <row>
    <udiDi>D-5713915SS004V9QS</udiDi>
    <basicUdiDi>B-5713915SS004V9QS</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® Liquid EGFR qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5675;5686;5550;5366;5575;5391;5545;5361;5555;5371;5540;5351;5570;5386;5560;5376;5565;5381;3075;5408</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:57.400Z</lastUpdated>
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  <row>
    <udiDi>D-5713915SS005VBRF</udiDi>
    <basicUdiDi>B-5713915SS005VBRF</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE KRAS qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1900;1701;1905;1706;1910;1711;1915;1716;1925;1726;1930;1731;1940;1741;1945;1746;1955;1756;1960;1761</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:55.304Z</lastUpdated>
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  <row>
    <udiDi>D-5713915SS003V7QH</udiDi>
    <basicUdiDi>B-5713915SS003V7QH</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE EGFR qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5670;5681;2085;2081;3027;3071;2075;2071;2095;2091;2065;2061;3025;3021;3005;3001;3015;3011;3077;5398</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:55.237Z</lastUpdated>
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    <udiDi>D-5713915SS002V5Q8</udiDi>
    <basicUdiDi>B-5713915SS002V5Q8</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® Liquid BRAF qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5525; 5530; 5535; 5336; 5341; 5346</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:37.298Z</lastUpdated>
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    <udiDi>D-5713915SS001V3PX</udiDi>
    <basicUdiDi>B-5713915SS001V3PX</basicUdiDi>
    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE BRAF qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1398;1402;1400;1831;1836;1841</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:36.416Z</lastUpdated>
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  <row>
    <udiDi>07332940002282</udiDi>
    <basicUdiDi>B-07332940002282</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® Bladder Cancer Monitor</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXBLAD-CM-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:48.265Z</lastUpdated>
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  <row>
    <udiDi>07332940002268</udiDi>
    <basicUdiDi>B-07332940002268</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® Bladder Cancer Detection</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXBLAD-CD-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:45.786Z</lastUpdated>
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    <udiDi>D-06971808258440VM</udiDi>
    <basicUdiDi>B-06971808258440VM</basicUdiDi>
    <tradeName>Fast Fluorescence In Situ Hybridization Probe Kit</tradeName>
    <deviceName>MYC(8q24)/BCL6(3q27)/BCL2(18q21) gene break apart probe reagent</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-243-3</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:08:58.822Z</lastUpdated>
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    <udiDi>D-06971808257788WR</udiDi>
    <basicUdiDi>B-06971808257788WR</basicUdiDi>
    <tradeName>Fast Fluorescence In Situ Hybridization Probe Kit</tradeName>
    <deviceName>CCND1 (BCL1) gene break apart probe reagent</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-042</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:08:58.017Z</lastUpdated>
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</eudamedExport>