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    <basicUdiDi>697535299G8P001H2</basicUdiDi>
    <tradeName>Focused Ultrasonicator</tradeName>
    <deviceName></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 Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB5002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:06.082Z</lastUpdated>
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    <udiDi>06975352996018</udiDi>
    <basicUdiDi>697535299BOX001QB</basicUdiDi>
    <tradeName>Gene+Box Data Analysis and Management System</tradeName>
    <deviceName></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 Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED5001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:06.057Z</lastUpdated>
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    <udiDi>06975352996025</udiDi>
    <basicUdiDi>B-06975352996025</basicUdiDi>
    <tradeName>Oncology Multi-Gene Variant Assay</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KB5002048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:06.031Z</lastUpdated>
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    <udiDi>06975352996032</udiDi>
    <basicUdiDi>B-06975352996032</basicUdiDi>
    <tradeName>Oncology 59-Gene Variant Assay</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KB5005048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:06.008Z</lastUpdated>
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    <udiDi>06975352996049</udiDi>
    <basicUdiDi>697535299G1600196</basicUdiDi>
    <tradeName>Automated Workstation</tradeName>
    <deviceName></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 Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB5001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:05.986Z</lastUpdated>
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    <udiDi>06975352996056</udiDi>
    <basicUdiDi>B-06975352996056</basicUdiDi>
    <tradeName>Oncology Fusion-Gene Variant Assay (M)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>117121302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:05.965Z</lastUpdated>
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    <udiDi>06975352996070</udiDi>
    <basicUdiDi>B-06975352996070</basicUdiDi>
    <tradeName>Oncology 188-Gene Variant Assay</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102122401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:05.945Z</lastUpdated>
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    <udiDi>06975352996094</udiDi>
    <basicUdiDi>B-06975352996094</basicUdiDi>
    <tradeName>Oncology Fusion-Gene Variant Assay</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>117122301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:05.920Z</lastUpdated>
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  <row>
    <udiDi>06975352996117</udiDi>
    <basicUdiDi>B-06975352996117</basicUdiDi>
    <tradeName>Oncology HRD Assay (M)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>115021301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:05.898Z</lastUpdated>
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    <udiDi>06975352996155</udiDi>
    <basicUdiDi>B-06975352996155</basicUdiDi>
    <tradeName>Comprehensive Genomic Profiling Based MRD Detection Assay (M)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106021302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:05.878Z</lastUpdated>
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  <row>
    <udiDi>06975352996179</udiDi>
    <basicUdiDi>B-06975352996179</basicUdiDi>
    <tradeName>Comprehensive Multi-Gene Variant Assay</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103122301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:05.856Z</lastUpdated>
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  <row>
    <udiDi>06975352996193</udiDi>
    <basicUdiDi>B-06975352996193</basicUdiDi>
    <tradeName>Oncology 188-Gene Variant Assay (M)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102121303</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:05.836Z</lastUpdated>
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  <row>
    <udiDi>06975352996216</udiDi>
    <basicUdiDi>B-06975352996216</basicUdiDi>
    <tradeName>Oncology 188-Gene Variant Assay (HT)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102122303</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:05.813Z</lastUpdated>
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  <row>
    <udiDi>06975352996230</udiDi>
    <basicUdiDi>B-06975352996230</basicUdiDi>
    <tradeName>Comprehensive Pathogen NA Test Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101122103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:05.792Z</lastUpdated>
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    <udiDi>06975352996254</udiDi>
    <basicUdiDi>B-06975352996254</basicUdiDi>
    <tradeName>Circulating Tumour DNA 1021-Gene Variant Assay</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KB5003048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:05.775Z</lastUpdated>
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