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    <udiDi>06975760470179</udiDi>
    <basicUdiDi>B-06975760470179</basicUdiDi>
    <tradeName>Human JAK2 Gene V617F Mutation Detection Kit (Digital PCR Method)</tradeName>
    <deviceName>Human JAK2 Gene V617F Mutation Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Suzhou Precigenome Ltd, Co;</manufacturerName>
    <manufacturerSrn>CN-MF-000024105</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</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>3.02.03.0006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:11:20.520Z</lastUpdated>
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    <udiDi>06975296640503</udiDi>
    <basicUdiDi>B-06975296640503</basicUdiDi>
    <tradeName>06975296640503</tradeName>
    <deviceName>Pan MPN qPCR Panel</deviceName>
    <manufacturerName>MEDx (Suzhou) Translational Medicine Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028603</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>EU005A01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:26:42.342Z</lastUpdated>
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    <udiDi>06975296640497</udiDi>
    <basicUdiDi>B-06975296640497</basicUdiDi>
    <tradeName>06975296640497</tradeName>
    <deviceName>c-MET Exon 14 Skipping RT-qPCR Test</deviceName>
    <manufacturerName>MEDx (Suzhou) Translational Medicine Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028603</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>EU001A01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:26:41.548Z</lastUpdated>
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    <udiDi>06975296640459</udiDi>
    <basicUdiDi>B-06975296640459</basicUdiDi>
    <tradeName>06975296640459</tradeName>
    <deviceName>B cell Receptor (BCR) Sequencing Panel</deviceName>
    <manufacturerName>MEDx (Suzhou) Translational Medicine Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028603</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>EU004A01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:26:35.951Z</lastUpdated>
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    <udiDi>06975240820173</udiDi>
    <basicUdiDi>B-06975240820173</basicUdiDi>
    <tradeName>06975240820173</tradeName>
    <deviceName>PulmoSeek® Early Lung Cancer Assay Kit</deviceName>
    <manufacturerName>AnchorDx Medical Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054821</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>96 Tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:59.714Z</lastUpdated>
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  <row>
    <udiDi>06975240820166</udiDi>
    <basicUdiDi>B-06975240820166</basicUdiDi>
    <tradeName>06975240820166</tradeName>
    <deviceName>Gastromia® Gastric Cancer Assay Kit</deviceName>
    <manufacturerName>AnchorDx Medical Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054821</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>40 Tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:55.715Z</lastUpdated>
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    <udiDi>06975029660402</udiDi>
    <basicUdiDi>B-06975029660402</basicUdiDi>
    <tradeName>Onco PanScan™ Gene Mutation Detection Kit</tradeName>
    <deviceName>Onco PanScan™ Gene Mutation Detection Kit</deviceName>
    <manufacturerName>Genetron Health (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046433</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>RSN042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:56.295Z</lastUpdated>
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  <row>
    <udiDi>06975029660396</udiDi>
    <basicUdiDi>B-06975029660396</basicUdiDi>
    <tradeName>Onco PanScan™ Gene Mutation Detection Kit</tradeName>
    <deviceName>Onco PanScan™ Gene Mutation Detection Kit</deviceName>
    <manufacturerName>Genetron Health (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046433</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>RSN041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:52.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975029660297</udiDi>
    <basicUdiDi>B-06975029660297</basicUdiDi>
    <tradeName>Lung Basic Mutations Detection Kit</tradeName>
    <deviceName>Lung Basic Mutations Detection Kit</deviceName>
    <manufacturerName>Genetron Health (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046433</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>RSN133</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:51.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975029660280</udiDi>
    <basicUdiDi>B-06975029660280</basicUdiDi>
    <tradeName>Onco PanScan™ Gene Mutation Detection Kit</tradeName>
    <deviceName>Onco PanScan™ Gene Mutation Detection Kit</deviceName>
    <manufacturerName>Genetron Health (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046433</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>RSN043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:50.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975029660389</udiDi>
    <basicUdiDi>B-06975029660389</basicUdiDi>
    <tradeName>Human B Lymphocyte Minimal Residual Disease Detection Kit</tradeName>
    <deviceName>Human B Lymphocyte Minimal Residual Disease Detection Kit</deviceName>
    <manufacturerName>Genetron Health (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046433</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>RSN040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:49.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975029660273</udiDi>
    <basicUdiDi>B-06975029660273</basicUdiDi>
    <tradeName>Onco PanScanTM Gene Mutation Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genetron Health (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046433</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSN042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:34.587Z</lastUpdated>
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  <row>
    <udiDi>06975029660266</udiDi>
    <basicUdiDi>B-06975029660266</basicUdiDi>
    <tradeName>Onco PanScanTM Gene Mutation Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genetron Health (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046433</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSN041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:32.187Z</lastUpdated>
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  <row>
    <udiDi>06975029660259</udiDi>
    <basicUdiDi>B-06975029660259</basicUdiDi>
    <tradeName>Human B Lymphocyte Minimal Residual Disease Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genetron Health (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046433</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSN040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:30.587Z</lastUpdated>
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  <row>
    <udiDi>06975029660211</udiDi>
    <basicUdiDi>B-06975029660211</basicUdiDi>
    <tradeName>Human B Lymphocyte Minimal Residual Disease Detection Kit</tradeName>
    <deviceName>Human B Lymphocyte Minimal Residual Disease Detection Kit</deviceName>
    <manufacturerName>Genetron Health (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046433</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>RSN039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:25.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975029660181</udiDi>
    <basicUdiDi>B-06975029660181</basicUdiDi>
    <tradeName>Human IDH1 Mutations Detection Kit (Real-Time PCR)</tradeName>
    <deviceName>Human IDH1 Mutations Detection Kit (Real-Time PCR)</deviceName>
    <manufacturerName>Genetron Health (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046433</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</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>RPQ005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:24.189Z</lastUpdated>
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  <row>
    <udiDi>06975029660174</udiDi>
    <basicUdiDi>B-06975029660174</basicUdiDi>
    <tradeName>Human TERT Promoter Mutations Detection Kit (Real-Time PCR)</tradeName>
    <deviceName>Human TERT Promoter Mutations Detection Kit (Real-Time PCR）</deviceName>
    <manufacturerName>Genetron Health (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046433</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</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>RPQ008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:29:23.384Z</lastUpdated>
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  <row>
    <udiDi>06974968584053</udiDi>
    <basicUdiDi>B-06974968584053</basicUdiDi>
    <tradeName>GeneMind</tradeName>
    <deviceName>Lung Cancer Circulating Tumor DNA Multi-gene Mutation Combined Detection Kit ( Reversible Terminator Sequencing)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</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>L000180</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:08:13.835Z</lastUpdated>
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  <row>
    <udiDi>06974968584046</udiDi>
    <basicUdiDi>B-06974968584046</basicUdiDi>
    <tradeName>GeneMind</tradeName>
    <deviceName>Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencing)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</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>L000179</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:08:12.215Z</lastUpdated>
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  <row>
    <udiDi>06974968583209</udiDi>
    <basicUdiDi>B-06974968583209</basicUdiDi>
    <tradeName>Lung Cancer Circulating Tumor DNA Multi-gene Mutation Combined Detection Kit ( Reversible Terminator Sequencing)</tradeName>
    <deviceName>Lung Cancer Circulating Tumor DNA Multi-gene Mutation Combined Detection Kit ( Reversible Terminator Sequencing)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</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>L000046</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:07:48.209Z</lastUpdated>
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