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    <basicUdiDi>697576047CRS5RQ</basicUdiDi>
    <tradeName>06975760470032</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Precigenome Ltd, Co;</manufacturerName>
    <manufacturerSrn>CN-MF-000024105</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L1699</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:22:13.693Z</lastUpdated>
  </row>
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    <udiDi>06975760470049</udiDi>
    <basicUdiDi>697576047CRS3RL</basicUdiDi>
    <tradeName>06975760470049</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Precigenome Ltd, Co;</manufacturerName>
    <manufacturerSrn>CN-MF-000024105</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L1699</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:22:13.667Z</lastUpdated>
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    <udiDi>06975760470124</udiDi>
    <basicUdiDi>697576047CRS7RU</basicUdiDi>
    <tradeName>06975760470124</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Precigenome Ltd, Co;</manufacturerName>
    <manufacturerSrn>CN-MF-000024105</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L1699</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:22:13.647Z</lastUpdated>
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    <udiDi>06975760470131</udiDi>
    <basicUdiDi>697576047RS32S3</basicUdiDi>
    <tradeName>06975760470131</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Precigenome Ltd, Co;</manufacturerName>
    <manufacturerSrn>CN-MF-000024105</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS3204 , RS3205, RS3206, RS3207</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:22:13.638Z</lastUpdated>
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  <row>
    <udiDi>06975760470148</udiDi>
    <basicUdiDi>B-06975760470148</basicUdiDi>
    <tradeName>Sepsis pathogenic microorganism detection kit (digital PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Precigenome Ltd, Co;</manufacturerName>
    <manufacturerSrn>CN-MF-000024105</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.02.03.0007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:22:13.625Z</lastUpdated>
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  <row>
    <udiDi>06975760470162</udiDi>
    <basicUdiDi>B-06975760470162</basicUdiDi>
    <tradeName>BCR ABL p210/p190 digital PCR one-tube quant test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Precigenome Ltd, Co;</manufacturerName>
    <manufacturerSrn>CN-MF-000024105</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.02.03.0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:22:13.610Z</lastUpdated>
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  <row>
    <udiDi>06975760470179</udiDi>
    <basicUdiDi>B-06975760470179</basicUdiDi>
    <tradeName>Human JAK2 Gene V617F Mutation Detection Kit (Digital PCR Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Precigenome Ltd, Co;</manufacturerName>
    <manufacturerSrn>CN-MF-000024105</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.02.03.0006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:22:13.597Z</lastUpdated>
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  <row>
    <udiDi>06975760470186</udiDi>
    <basicUdiDi>B-06975760470186</basicUdiDi>
    <tradeName>PIK3CA 11 Mutations Digital PCR Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Precigenome Ltd, Co;</manufacturerName>
    <manufacturerSrn>CN-MF-000024105</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.02.03.0005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:22:13.588Z</lastUpdated>
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