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    <tradeName>Fast Fluorescence In Situ Hybridization Probe Kit</tradeName>
    <deviceName>1p/19q deletion probe reagent</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
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    <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>
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    <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>
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    <tradeName>Fast Fluorescence In Situ Hybridization Probe Kit</tradeName>
    <deviceName>MDM2 gene amplification probe reagent</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
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    <tradeName>Fast Fluorescence In Situ Hybridization Probe Kit</tradeName>
    <deviceName>DDIT3 (12q13) gene rearrangement probe reagent</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <tradeName>Local Run Manager TruSight Oncology Comprehensive (EU) Analysis Module</tradeName>
    <deviceName>TruSight™ Oncology Comprehensive (EU)</deviceName>
    <manufacturerName>Illumina, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013476</manufacturerSrn>
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    <tradeName>TRUPCR® MPL Kit</tradeName>
    <deviceName>TRUPCR® MPL Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
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    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:12.130Z</lastUpdated>
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    <tradeName>Diagnostic Kit for Methylated Genes of Gastric Cancer（Real Time PCR）</tradeName>
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    <manufacturerName>Excellen Medical Technology Co.,Ltd.</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
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    <reference>Diagnostic Kit for Methylated Genes of Gastric Cancer（Real Time PCR）</reference>
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    <lastUpdated>2026-07-16T07:58:25.352Z</lastUpdated>
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    <tradeName>Diagnostic Kit for Methylated Genes of Breast Cancer（Real Time PCR）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Excellen Medical Technology Co.,Ltd.</manufacturerName>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BRC-PCR-30-CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:58:09.803Z</lastUpdated>
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    <tradeName>Diagnostic Kit for Methylated Genes of Colorectal Cancer（Real Time PCR）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Excellen Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010402</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <tradeName>Diagnostic Kit for Methylated Genes of Lung Cancer（Real Time PCR）</tradeName>
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    <manufacturerName>Excellen Medical Technology Co.,Ltd.</manufacturerName>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
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    <reference>Diagnostic Kit for Methylated Genes of Lung Cancer（Real Time PCR）</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:58:08.197Z</lastUpdated>
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    <tradeName>ipsogen JAK2 RGQ PCR Kit</tradeName>
    <deviceName>ipsogen JAK2 RGQ PCR Kit</deviceName>
    <manufacturerName>QIAGEN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>674623</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:31:44.279Z</lastUpdated>
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    <tradeName>PredicineCARE Assay</tradeName>
    <deviceName>PredicineCARE™ Assay</deviceName>
    <manufacturerName>Predicine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000031888</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
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    <reference>PD-CA9999KE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:55:10.888Z</lastUpdated>
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    <tradeName>Oncomine™ Dx Target Test (DNA and RNA Panel)</tradeName>
    <deviceName>Oncomine™ Dx Target Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A65534 （A65538)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:51:01.346Z</lastUpdated>
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    <tradeName>UROMONITOR</tradeName>
    <deviceName>UROMONITOR</deviceName>
    <manufacturerName>Infogene, Lda.</manufacturerName>
    <manufacturerSrn>PT-MF-000047847</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:54.537Z</lastUpdated>
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    <tradeName>Oncomine™ Dx Express Test Plasma cfTNA Control</tradeName>
    <deviceName>Oncomine™ Dx Express Test Plasma cfTNA Control, a part of Ion Torrent™ Oncomine™ Dx Express Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <tradeName>Oncomine™ Dx Express Test FFPE RNA Control</tradeName>
    <deviceName>Oncomine™ Dx Express Test FFPE RNA Control, a part of Ion Torrent™ Oncomine™ Dx Express Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
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    <manufacturerName>Life Technologies Corporation</manufacturerName>
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