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    <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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    <udiDi>D-AD06-96CE8V</udiDi>
    <basicUdiDi>B-AD06-96CE8V</basicUdiDi>
    <tradeName>IColohunter</tradeName>
    <deviceName>Plasma DNA Methylation Detection Kit for Colorectal Cancer (Real-Time PCR)</deviceName>
    <manufacturerName>Wuhan Ammunition Life-tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037251</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-12T18:28:32.418Z</lastUpdated>
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    <udiDi>D-AD06-24CE72</udiDi>
    <basicUdiDi>B-AD06-24CE72</basicUdiDi>
    <tradeName>IColohunter</tradeName>
    <deviceName>Plasma DNA Methylation Detection Kit for Colorectal Cancer (Real-Time PCR)</deviceName>
    <manufacturerName>Wuhan Ammunition Life-tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037251</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>D-AD01-96CE6U</udiDi>
    <basicUdiDi>B-AD01-96CE6U</basicUdiDi>
    <tradeName>IColocomf</tradeName>
    <deviceName>Stool DNA Methylation Detection Kit for Colorectal Cancer (Real-Time PCR)</deviceName>
    <manufacturerName>Wuhan Ammunition Life-tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037251</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD01-96CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:21.812Z</lastUpdated>
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    <udiDi>D-AD01-48CE63</udiDi>
    <basicUdiDi>B-AD01-48CE63</basicUdiDi>
    <tradeName>IColocomf</tradeName>
    <deviceName>Stool DNA Methylation Detection Kit for Colorectal Cancer (Real-Time PCR)</deviceName>
    <manufacturerName>Wuhan Ammunition Life-tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037251</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD01-48CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:20.204Z</lastUpdated>
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    <udiDi>D-AD01-24CE4Z</udiDi>
    <basicUdiDi>B-AD01-24CE4Z</basicUdiDi>
    <tradeName>IColocomf</tradeName>
    <deviceName>Stool DNA Methylation Detection Kit for Colorectal Cancer (Real-Time PCR)</deviceName>
    <manufacturerName>Wuhan Ammunition Life-tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037251</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD01-24CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:17.800Z</lastUpdated>
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    <udiDi>08885013956085</udiDi>
    <basicUdiDi>B-08885013956085</basicUdiDi>
    <tradeName>Sentosa SQ CRC Panel (4x8)</tradeName>
    <deviceName>Sentosa SQ CRC Panel (4x8)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>690012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:19:45.190Z</lastUpdated>
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    <udiDi>06975296640527</udiDi>
    <basicUdiDi>B-06975296640527</basicUdiDi>
    <tradeName>06975296640527</tradeName>
    <deviceName>MMR IHC 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>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU007A01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:26:47.177Z</lastUpdated>
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    <udiDi>06974968583186</udiDi>
    <basicUdiDi>B-06974968583186</basicUdiDi>
    <tradeName>DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes （Real-Time PCR）</tradeName>
    <deviceName>DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes （Real-Time PCR）</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000045;L000048</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:07:50.623Z</lastUpdated>
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    <udiDi>06974968583193</udiDi>
    <basicUdiDi>B-06974968583193</basicUdiDi>
    <tradeName>DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes （Real-Time PCR）</tradeName>
    <deviceName>DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes （Real-Time PCR）</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000048</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:07:47.495Z</lastUpdated>
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    <udiDi>06974870710212</udiDi>
    <basicUdiDi>B-06974870710212</basicUdiDi>
    <tradeName>06974870710212</tradeName>
    <deviceName>TGS Human B-raf Gene V600E 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>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM150021</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:00:57.087Z</lastUpdated>
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    <udiDi>06974870710113</udiDi>
    <basicUdiDi>B-06974870710113</basicUdiDi>
    <tradeName>06974870710113</tradeName>
    <deviceName>Human B-raf Gene V600E Mutation Detection Kit (Fluorescence PCR 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>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P111H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:00:26.628Z</lastUpdated>
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    <udiDi>06974689627206</udiDi>
    <basicUdiDi>B-06974689627206</basicUdiDi>
    <tradeName>MSI digital PCR detection kit</tradeName>
    <deviceName>MSI 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>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12690-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:35.463Z</lastUpdated>
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    <udiDi>05713915000441</udiDi>
    <basicUdiDi>5713915MS001SZ</basicUdiDi>
    <tradeName>MicroSight® MSI 1-Step HRM Analysis</tradeName>
    <deviceName>MicroSight® MSI 1-Step HRM Analysis</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7201</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:52:12.681Z</lastUpdated>
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    <udiDi>15415219001328</udiDi>
    <basicUdiDi>5415219A0220BV</basicUdiDi>
    <tradeName>Idylla™ CDx MSI Test</tradeName>
    <deviceName>Idylla™ CDx MSI Test</deviceName>
    <manufacturerName>Biocartis NV</manufacturerName>
    <manufacturerSrn>BE-MF-000003661</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0220/6</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:05:30.868Z</lastUpdated>
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    <udiDi>06970110910022</udiDi>
    <basicUdiDi>B-06970110910022</basicUdiDi>
    <tradeName>06970110910022</tradeName>
    <deviceName>Septin9 Gene Methylation Detection Kit for Human Colorectal Cancer (Real-Time PCR)</deviceName>
    <manufacturerName>BioChain (Beijing) Science &amp; Technology, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000038431</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-0002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:15:21.255Z</lastUpdated>
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