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    <udiDi>D-BS0121ILLCSMY08-323Q</udiDi>
    <basicUdiDi>B-BS0121ILLCSMY08-323Q</basicUdiDi>
    <tradeName>D-BS0121ILLCSMY08-323Q</tradeName>
    <deviceName>SOPHiA DDM DX Homologous Recombination Deficiency Solution</deviceName>
    <manufacturerName>SOPHiA GENETICS SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025221</manufacturerSrn>
    <authorisedRepresentativeName>SOPHiA GENETICS SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000022214</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>BS0121ILLCSMY08-32</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:18.984Z</lastUpdated>
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    <udiDi>D-BS0119ILLCSRY07-32F3</udiDi>
    <basicUdiDi>B-BS0119ILLCSRY07-32F3</basicUdiDi>
    <tradeName>D-BS0119ILLCSRY07-32F3</tradeName>
    <deviceName>SOPHiA DDM Dx RNAtarget Oncology Solution</deviceName>
    <manufacturerName>SOPHiA GENETICS SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025221</manufacturerSrn>
    <authorisedRepresentativeName>SOPHiA GENETICS SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000022214</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>BS0119ILLCSRY07-32</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:18.150Z</lastUpdated>
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    <udiDi>D-BS0105ILLCSML03ZJ</udiDi>
    <basicUdiDi>B-BS0105ILLCSML03ZJ</basicUdiDi>
    <tradeName>D-BS0105ILLCSML03ZJ</tradeName>
    <deviceName>SOPHiA DDM Dx Solid Tumor Solution</deviceName>
    <manufacturerName>SOPHiA GENETICS SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025221</manufacturerSrn>
    <authorisedRepresentativeName>SOPHiA GENETICS SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000022214</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>BS0105ILLCSML03</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:14.149Z</lastUpdated>
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    <udiDi>D-BS0103ILLCSML01XL</udiDi>
    <basicUdiDi>B-BS0103ILLCSML01XL</basicUdiDi>
    <tradeName>D-BS0103ILLCSML01XL</tradeName>
    <deviceName>SOPHiA DDM Dx Myeloid Solution</deviceName>
    <manufacturerName>SOPHiA GENETICS SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025221</manufacturerSrn>
    <authorisedRepresentativeName>SOPHiA GENETICS SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000022214</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>BS0103ILLCSML01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:13.348Z</lastUpdated>
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    <udiDi>D-BS0102ILLCGLL01-096AG</udiDi>
    <basicUdiDi>B-BS0102ILLCGLL01-096AG</basicUdiDi>
    <tradeName>D-BS0102ILLCGLL01-096AG</tradeName>
    <deviceName>SOPHiA DDM Dx Hereditary Cancer Solution</deviceName>
    <manufacturerName>SOPHiA GENETICS SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025221</manufacturerSrn>
    <authorisedRepresentativeName>SOPHiA GENETICS SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000022214</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>BS0102ILLCGLL01-096</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:12.547Z</lastUpdated>
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    <udiDi>D-BS0102ILLCGLL01-048A5</udiDi>
    <basicUdiDi>B-BS0102ILLCGLL01-048A5</basicUdiDi>
    <tradeName>D-BS0102ILLCGLL01-048A5</tradeName>
    <deviceName>SOPHiA DDM Dx Hereditary Cancer Solution</deviceName>
    <manufacturerName>SOPHiA GENETICS SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025221</manufacturerSrn>
    <authorisedRepresentativeName>SOPHiA GENETICS SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000022214</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>BS0102ILLCGLL01-048</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:11.758Z</lastUpdated>
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    <udiDi>D-BS0102ILLCGLL01-0329N</udiDi>
    <basicUdiDi>B-BS0102ILLCGLL01-0329N</basicUdiDi>
    <tradeName>D-BS0102ILLCGLL01-0329N</tradeName>
    <deviceName>SOPHiA DDM Dx Hereditary Cancer Solution</deviceName>
    <manufacturerName>SOPHiA GENETICS SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025221</manufacturerSrn>
    <authorisedRepresentativeName>SOPHiA GENETICS SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000022214</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>BS0102ILLCGLL01-032</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:07.746Z</lastUpdated>
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    <udiDi>D-BS0102ILLCGLL01-0169Q</udiDi>
    <basicUdiDi>B-BS0102ILLCGLL01-0169Q</basicUdiDi>
    <tradeName>D-BS0102ILLCGLL01-0169Q</tradeName>
    <deviceName>SOPHiA DDM Dx Hereditary Cancer Solution</deviceName>
    <manufacturerName>SOPHiA GENETICS SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025221</manufacturerSrn>
    <authorisedRepresentativeName>SOPHiA GENETICS SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000022214</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>BS0102ILLCGLL01-016</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:05.346Z</lastUpdated>
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  <row>
    <udiDi>D-AD10-96CE6Y</udiDi>
    <basicUdiDi>B-AD10-96CE6Y</basicUdiDi>
    <tradeName>Iesohunter</tradeName>
    <deviceName>Plasma DNA Methylation Detection Kit for Esophageal 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD10-96CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:37.807Z</lastUpdated>
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    <udiDi>D-AD10-24CE55</udiDi>
    <basicUdiDi>B-AD10-24CE55</basicUdiDi>
    <tradeName>IEsohunter</tradeName>
    <deviceName>Plasma DNA Methylation Detection Kit for Esophageal 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD10-24CE,</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:36.205Z</lastUpdated>
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    <udiDi>D-AD07-96CE9A</udiDi>
    <basicUdiDi>B-AD07-96CE9A</basicUdiDi>
    <tradeName>IHepcomf</tradeName>
    <deviceName>Plasma DNA Methylation Detection Kit for Liver 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD07-96CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:35.466Z</lastUpdated>
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    <udiDi>D-AD07-24CE7F</udiDi>
    <basicUdiDi>B-AD07-24CE7F</basicUdiDi>
    <tradeName>IHepcomf</tradeName>
    <deviceName>Plasma DNA Methylation Detection Kit for Liver 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD07-24CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:33.809Z</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>
    <reference>AD06-96CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <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>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD06-24CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:31.107Z</lastUpdated>
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    <udiDi>D-AD03-96CE7N</udiDi>
    <basicUdiDi>B-AD03-96CE7N</basicUdiDi>
    <tradeName>IUterusure</tradeName>
    <deviceName>DNA Methylation Detection Kit for Endometrial 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD03-96CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:29.320Z</lastUpdated>
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    <udiDi>D-AD03-24CE5T</udiDi>
    <basicUdiDi>B-AD03-24CE5T</basicUdiDi>
    <tradeName>IUterusure</tradeName>
    <deviceName>DNA Methylation Detection Kit for Endometrial 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD03-24CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:27.397Z</lastUpdated>
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    <udiDi>D-AD02-96CE79</udiDi>
    <basicUdiDi>B-AD02-96CE79</basicUdiDi>
    <tradeName>ICervsure</tradeName>
    <deviceName>DNA Methylation Detection Kit for Cervical 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD02-96CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:24.205Z</lastUpdated>
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    <udiDi>D-AD02-48CE6G</udiDi>
    <basicUdiDi>B-AD02-48CE6G</basicUdiDi>
    <tradeName>ICervsure</tradeName>
    <deviceName>DNA Methylation Detection Kit for Cervical 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>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD02-48CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:22.602Z</lastUpdated>
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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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