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    <tradeName>SensiScreen</tradeName>
    <deviceName>SensiScreen® FFPE KRAS qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <udiDi>D-G2M708421G7</udiDi>
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    <tradeName>KRAS-Q Real-Time PCR Kit</tradeName>
    <deviceName>KRAS-Q Real-Time PCR Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
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    <udiDi>D-81649002AKRAS01JF42</udiDi>
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    <deviceName>KRAS Gene Mutation Detection Kit（Fluorescence PCR）</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
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    <deviceName>PNAClamp™ KRAS Mutation Detection Kit (Ver.4)</deviceName>
    <manufacturerName>HLB PANAGENE</manufacturerName>
    <manufacturerSrn>KR-MF-000042004</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNAC-1006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:46:09.281Z</lastUpdated>
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    <udiDi>06975977070100</udiDi>
    <basicUdiDi>B-06975977070100</basicUdiDi>
    <tradeName>06975977070100</tradeName>
    <deviceName>KRAS/NRAS/PIK3CA/BRAF  Mutations Detection Kit （Real-time PCR Assays）</deviceName>
    <manufacturerName>Gold Probe Diagnostic Biotechnology Inc. MF</manufacturerName>
    <manufacturerSrn>CN-MF-000031524</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>600010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:25.581Z</lastUpdated>
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    <udiDi>06974870710229</udiDi>
    <basicUdiDi>B-06974870710229</basicUdiDi>
    <tradeName>06974870710229</tradeName>
    <deviceName>TGS Human K-ras Gene Mutation Detection Kit</deviceName>
    <manufacturerName>Wuxi Ruiqi Gene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027697</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM150022</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:00:57.896Z</lastUpdated>
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    <udiDi>06974870710120</udiDi>
    <basicUdiDi>B-06974870710120</basicUdiDi>
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    <deviceName>Human K-ras Gene Mutation Detection Kit (PCR-Melting Curve Method)</deviceName>
    <manufacturerName>Wuxi Ruiqi Gene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027697</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>P112H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:00:29.016Z</lastUpdated>
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    <udiDi>06974689627312</udiDi>
    <basicUdiDi>B-06974689627312</basicUdiDi>
    <tradeName>KRAS mutation digital PCR detection kit</tradeName>
    <deviceName>KRAS mutation digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12541-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:54.680Z</lastUpdated>
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    <udiDi>06974689627053</udiDi>
    <basicUdiDi>B-06974689627053</basicUdiDi>
    <tradeName>KRAS/BRAF/NRAS/PIK3CA mutations digital PCR detection kit</tradeName>
    <deviceName>KRAS/BRAF/NRAS/PIK3CA mutations digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12608-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:07.537Z</lastUpdated>
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    <udiDi>06974689626582</udiDi>
    <basicUdiDi>B-06974689626582</basicUdiDi>
    <tradeName>KRAS mutation digital PCR detection kit</tradeName>
    <deviceName>KRAS mutation digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12541-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:26:11.348Z</lastUpdated>
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    <udiDi>06974689626063</udiDi>
    <basicUdiDi>B-06974689626063</basicUdiDi>
    <tradeName>KRAS/BRAF/NRAS/PIK3CA mutations digital PCR detection kit</tradeName>
    <deviceName>KRAS/BRAF/NRAS/PIK3CA mutations digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12608-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:04.576Z</lastUpdated>
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    <udiDi>06974604720005</udiDi>
    <basicUdiDi>B-06974604720005</basicUdiDi>
    <tradeName>06974604720005</tradeName>
    <deviceName>Human KRAS Gene Seven Mutation Detection Kit PCR-Fluorescence Method)</deviceName>
    <manufacturerName>Wuhan YZY Medical Science and Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036323</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YZYMT-001-CE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:00:58.726Z</lastUpdated>
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    <udiDi>06974323012634</udiDi>
    <basicUdiDi>B-06974323012634</basicUdiDi>
    <tradeName>06974323012634</tradeName>
    <deviceName>Detection Kit for Eight Mutations of Human K-ras Gene (Fluorescent PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:51:12.308Z</lastUpdated>
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    <udiDi>08800087700181</udiDi>
    <basicUdiDi>88000877KRV3CD021DR</basicUdiDi>
    <tradeName>Droplex KRAS Mutation Test v3</tradeName>
    <deviceName>Droplex KRAS Mutation Test v3</deviceName>
    <manufacturerName>Gencurix, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000034097</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD021</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:32:48.793Z</lastUpdated>
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    <udiDi>06959094210755</udiDi>
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    <tradeName>06959094210755</tradeName>
    <deviceName>AmoyDx® KRAS Mutation Detection Kit</deviceName>
    <manufacturerName>Amoy Diagnostics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021843</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.01.0003</reference>
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    <tradeName>06959094206154</tradeName>
    <deviceName>AmoyDx® KRAS Mutation Detection Kit</deviceName>
    <manufacturerName>Amoy Diagnostics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021843</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.01.0128</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:30:15.516Z</lastUpdated>
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