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    <deviceName>SOX1-OT and HIST1H4F Methylation Real-time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
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    <reference>HBRT-BCDNAm</reference>
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    <lastUpdated>2026-07-06T09:59:58.706Z</lastUpdated>
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    <basicUdiDi>B-06927210914139</basicUdiDi>
    <tradeName>HER2/CEP17 Dual Color CISH Probe</tradeName>
    <deviceName>HER2/CEP17 Dual Color CISH Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <tradeName>HER2/CEP17 Dual Color CISH Probe</tradeName>
    <deviceName>HER2/CEP17 Dual Color CISH Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
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    <basicUdiDi>B-06927210914115</basicUdiDi>
    <tradeName>HER2/CEP17 Dual Color CISH Probe</tradeName>
    <deviceName>HER2/CEP17 Dual Color CISH Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0581</reference>
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    <udiDi>06927210914108</udiDi>
    <basicUdiDi>B-06927210914108</basicUdiDi>
    <tradeName>HER2/CEP17 Dual Color CISH Probe</tradeName>
    <deviceName>HER2/CEP17 Dual Color CISH Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0581</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:34.543Z</lastUpdated>
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    <udiDi>04251315808799</udiDi>
    <basicUdiDi>B-04251315808799</basicUdiDi>
    <tradeName>XL TCRA/D</tradeName>
    <deviceName>XL TCRA/D</deviceName>
    <manufacturerName>MetaSystems Probes GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006315</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>D-5106-100-OG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:43:36.951Z</lastUpdated>
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    <udiDi>04251315808515</udiDi>
    <basicUdiDi>B-04251315808515</basicUdiDi>
    <tradeName>04251315808515</tradeName>
    <deviceName>XL t(7;12) MNX1/ETV6</deviceName>
    <manufacturerName>MetaSystems Probes GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006315</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-5101-100-OG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:43:35.346Z</lastUpdated>
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    <basicUdiDi>B-04251315806108</basicUdiDi>
    <tradeName>XL Iso(17q)</tradeName>
    <deviceName>XL Iso(17q)</deviceName>
    <manufacturerName>MetaSystems Probes GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006315</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-5048-100-OG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:43:32.950Z</lastUpdated>
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    <udiDi>03770026953075</udiDi>
    <basicUdiDi>B-03770026953075</basicUdiDi>
    <tradeName>Genexpath</tradeName>
    <deviceName>SarcomaFusion 48U</deviceName>
    <manufacturerName>Genexpath</manufacturerName>
    <manufacturerSrn>FR-MF-000029325</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>GEP-SF48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:46.622Z</lastUpdated>
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    <udiDi>03770026953068</udiDi>
    <basicUdiDi>B-03770026953068</basicUdiDi>
    <tradeName>Genexpath</tradeName>
    <deviceName>SarcomaFusion 24U</deviceName>
    <manufacturerName>Genexpath</manufacturerName>
    <manufacturerSrn>FR-MF-000029325</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>GEP-SF24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:45.861Z</lastUpdated>
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    <udiDi>03770026953051</udiDi>
    <basicUdiDi>B-03770026953051</basicUdiDi>
    <tradeName>Genexpath</tradeName>
    <deviceName>SarcomaFusion 16U</deviceName>
    <manufacturerName>Genexpath</manufacturerName>
    <manufacturerSrn>FR-MF-000029325</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>GEP-SF16</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:45.035Z</lastUpdated>
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    <udiDi>03770026953044</udiDi>
    <basicUdiDi>B-03770026953044</basicUdiDi>
    <tradeName>Genexpath</tradeName>
    <deviceName>SarcomaFusion 8U</deviceName>
    <manufacturerName>Genexpath</manufacturerName>
    <manufacturerSrn>FR-MF-000029325</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>GEP-SF08</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:41.031Z</lastUpdated>
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    <udiDi>03770026953037</udiDi>
    <basicUdiDi>B-03770026953037</basicUdiDi>
    <tradeName>Genexpath</tradeName>
    <deviceName>LymphoSign 48U</deviceName>
    <manufacturerName>Genexpath</manufacturerName>
    <manufacturerSrn>FR-MF-000029325</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>GEP-LS48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:40.236Z</lastUpdated>
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    <udiDi>03770026953020</udiDi>
    <basicUdiDi>B-03770026953020</basicUdiDi>
    <tradeName>Genexpath</tradeName>
    <deviceName>LymphoSign 24U</deviceName>
    <manufacturerName>Genexpath</manufacturerName>
    <manufacturerSrn>FR-MF-000029325</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>GEP-LS24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:39.417Z</lastUpdated>
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    <basicUdiDi>B-03770026953013</basicUdiDi>
    <tradeName>Genexpath</tradeName>
    <deviceName>LymphoSign 16U</deviceName>
    <manufacturerName>Genexpath</manufacturerName>
    <manufacturerSrn>FR-MF-000029325</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:38.618Z</lastUpdated>
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    <basicUdiDi>B-03770026953006</basicUdiDi>
    <tradeName>Genexpath</tradeName>
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    <manufacturerName>Genexpath</manufacturerName>
    <manufacturerSrn>FR-MF-000029325</manufacturerSrn>
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    <reference>GEP-LS08</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:34.627Z</lastUpdated>
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    <basicUdiDi>B-00849811057137</basicUdiDi>
    <tradeName>OncoMate® 5C Matrix Standard</tradeName>
    <deviceName>OncoMate® 5C Matrix Standard</deviceName>
    <manufacturerName>Promega Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000034520</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD3850</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:50:47.110Z</lastUpdated>
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    <basicUdiDi>B-00849811057120</basicUdiDi>
    <tradeName>OncoMate® MSI Dx Analysis System</tradeName>
    <deviceName>OncoMate® MSI Dx Analysis System</deviceName>
    <manufacturerName>Promega Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000034520</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:50:43.114Z</lastUpdated>
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    <tradeName>TruSight™ Oncology Comprehensive (EU) kit</tradeName>
    <deviceName>TruSight Oncology Comprehensive (EU) kit</deviceName>
    <manufacturerName>Illumina, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013476</manufacturerSrn>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20063092</reference>
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    <tradeName>Human TEL-AML1 Fusion Gene Mutation Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Human TEL-AML1 Fusion Gene Mutation Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-TM016</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:15.731Z</lastUpdated>
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