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    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T7 App-D FCL PE150</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-001450-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:53:24.820Z</lastUpdated>
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    <udiDi>06975352996254</udiDi>
    <basicUdiDi>B-06975352996254</basicUdiDi>
    <tradeName>Circulating Tumour DNA 1021-Gene Variant Assay</tradeName>
    <deviceName>Circulating Tumour DNA 1021-Gene Variant Assay</deviceName>
    <manufacturerName>Suzhou GenePlus Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035774</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T19:29:29.016Z</lastUpdated>
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    <basicUdiDi>B-06975352996216</basicUdiDi>
    <tradeName>Oncology 188-Gene Variant Assay (HT)</tradeName>
    <deviceName>Oncology 188-Gene Variant Assay (HT)</deviceName>
    <manufacturerName>Suzhou GenePlus Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035774</manufacturerSrn>
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    <legislation>IVDD</legislation>
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    <udiDi>06975352996193</udiDi>
    <basicUdiDi>B-06975352996193</basicUdiDi>
    <tradeName>Oncology 188-Gene Variant Assay (M)</tradeName>
    <deviceName>Oncology 188-Gene Variant Assay (M)</deviceName>
    <manufacturerName>Suzhou GenePlus Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035774</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102121303</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:08.952Z</lastUpdated>
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    <udiDi>06975352996179</udiDi>
    <basicUdiDi>B-06975352996179</basicUdiDi>
    <tradeName>Comprehensive Multi-Gene Variant Assay</tradeName>
    <deviceName>Comprehensive Multi-Gene Variant Assay</deviceName>
    <manufacturerName>Suzhou GenePlus Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035774</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103122301</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:08.157Z</lastUpdated>
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    <udiDi>06975352996155</udiDi>
    <basicUdiDi>B-06975352996155</basicUdiDi>
    <tradeName>Comprehensive Genomic Profiling Based MRD Detection Assay (M)</tradeName>
    <deviceName>Comprehensive Genomic Profiling Based MRD Detection Assay (M)</deviceName>
    <manufacturerName>Suzhou GenePlus Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035774</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106021302</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:04.178Z</lastUpdated>
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    <udiDi>06975352996117</udiDi>
    <basicUdiDi>B-06975352996117</basicUdiDi>
    <tradeName>Oncology HRD Assay (M)</tradeName>
    <deviceName>Oncology HRD Assay (M)</deviceName>
    <manufacturerName>Suzhou GenePlus Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035774</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>115021301</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:03.359Z</lastUpdated>
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    <udiDi>06975352996094</udiDi>
    <basicUdiDi>B-06975352996094</basicUdiDi>
    <tradeName>Oncology Fusion-Gene Variant Assay</tradeName>
    <deviceName>Oncology Fusion-Gene Variant Assay</deviceName>
    <manufacturerName>Suzhou GenePlus Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035774</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>117122301</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:02.550Z</lastUpdated>
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    <udiDi>06975352996070</udiDi>
    <basicUdiDi>B-06975352996070</basicUdiDi>
    <tradeName>Oncology 188-Gene Variant Assay</tradeName>
    <deviceName>Oncology 188-Gene Variant Assay</deviceName>
    <manufacturerName>Suzhou GenePlus Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035774</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102122401</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:01.763Z</lastUpdated>
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    <udiDi>06975352996056</udiDi>
    <basicUdiDi>B-06975352996056</basicUdiDi>
    <tradeName>Oncology Fusion-Gene Variant Assay (M)</tradeName>
    <deviceName>Oncology Fusion-Gene Variant Assay (M)</deviceName>
    <manufacturerName>Suzhou GenePlus Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035774</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>117121302</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:28:57.745Z</lastUpdated>
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    <udiDi>06975352996032</udiDi>
    <basicUdiDi>B-06975352996032</basicUdiDi>
    <tradeName>Oncology 59-Gene Variant Assay</tradeName>
    <deviceName>Oncology 59-Gene Variant Assay</deviceName>
    <manufacturerName>Suzhou GenePlus Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035774</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KB5005048</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:28:56.961Z</lastUpdated>
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    <udiDi>06975352996025</udiDi>
    <basicUdiDi>B-06975352996025</basicUdiDi>
    <tradeName>Oncology Multi-Gene Variant Assay</tradeName>
    <deviceName>Oncology Multi-Gene Variant Assay</deviceName>
    <manufacturerName>Suzhou GenePlus Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035774</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KB5002048</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:28:56.161Z</lastUpdated>
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    <udiDi>06975139678229</udiDi>
    <basicUdiDi>B-06975139678229</basicUdiDi>
    <tradeName>CISOVA®</tradeName>
    <deviceName>Human CDO1 and HOXA9 Gene Methylation Detection kit（Real-time PCR）</deviceName>
    <manufacturerName>Beijing OriginPoly Bio-Tec Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:24.218Z</lastUpdated>
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    <udiDi>06975139678212</udiDi>
    <basicUdiDi>B-06975139678212</basicUdiDi>
    <tradeName>CISOVA®</tradeName>
    <deviceName>Human CDO1 and HOXA9 Gene Methylation Detection kit（Real-time PCR）</deviceName>
    <manufacturerName>Beijing OriginPoly Bio-Tec Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:23.411Z</lastUpdated>
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    <udiDi>06975139678205</udiDi>
    <basicUdiDi>B-06975139678205</basicUdiDi>
    <tradeName>CISOVA®</tradeName>
    <deviceName>Human CDO1 and HOXA9 Gene Methylation Detection kit（Real-time PCR）</deviceName>
    <manufacturerName>Beijing OriginPoly Bio-Tec Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:22.606Z</lastUpdated>
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    <udiDi>06975139678199</udiDi>
    <basicUdiDi>B-06975139678199</basicUdiDi>
    <tradeName>CISENDO®</tradeName>
    <deviceName>Human CDO1 and CELF4 Gene Methylation Detection Kit（Real-time PCR）</deviceName>
    <manufacturerName>Beijing OriginPoly Bio-Tec Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:21.822Z</lastUpdated>
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    <udiDi>06975139678182</udiDi>
    <basicUdiDi>B-06975139678182</basicUdiDi>
    <tradeName>CISENDO®</tradeName>
    <deviceName>Human CDO1 and CELF4 Gene Methylation Detection Kit（Real-time PCR）</deviceName>
    <manufacturerName>Beijing OriginPoly Bio-Tec Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:17.808Z</lastUpdated>
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    <udiDi>06975139678175</udiDi>
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    <tradeName>CISENDO®</tradeName>
    <deviceName>Human CDO1 and CELF4 Gene Methylation Detection Kit（Real-time PCR）</deviceName>
    <manufacturerName>Beijing OriginPoly Bio-Tec Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:17.006Z</lastUpdated>
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    <udiDi>06975139678168</udiDi>
    <basicUdiDi>B-06975139678168</basicUdiDi>
    <tradeName>CISCER®</tradeName>
    <deviceName>Human PAX1 and JAM3 Gene Methylation Detection kit（Real-time PCR）</deviceName>
    <manufacturerName>Beijing OriginPoly Bio-Tec Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:16.211Z</lastUpdated>
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    <tradeName>CISCER®</tradeName>
    <deviceName>Human PAX1 and JAM3 Gene Methylation Detection kit（Real-time PCR）</deviceName>
    <manufacturerName>Beijing OriginPoly Bio-Tec Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:15.413Z</lastUpdated>
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