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    <basicUdiDi>697982287CTCP0100G6</basicUdiDi>
    <tradeName>06979822870099</tradeName>
    <deviceName>Wash Buffer</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTCP0100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:47:08.484Z</lastUpdated>
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    <udiDi>06979822870075</udiDi>
    <basicUdiDi>697982287CTCP0001G3</basicUdiDi>
    <tradeName>06979822870075</tradeName>
    <deviceName>Buffer Solution</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTCP0001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:47:07.424Z</lastUpdated>
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    <udiDi>06979822870068</udiDi>
    <basicUdiDi>697982287IFYC0042H4</basicUdiDi>
    <tradeName>06979822870068</tradeName>
    <deviceName>Immuno-Chromogenic Reagent</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030708</emdnCode>
    <emdnDescription>STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFYC0042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:47:06.617Z</lastUpdated>
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    <udiDi>06979822870082</udiDi>
    <basicUdiDi>697982287CTCP0003G7</basicUdiDi>
    <tradeName>06979822870082</tradeName>
    <deviceName>Sample Separation Media</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTCP0003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:47:05.823Z</lastUpdated>
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    <udiDi>06979822870051</udiDi>
    <basicUdiDi>697982287IFCP0005CF</basicUdiDi>
    <tradeName>06979822870051</tradeName>
    <deviceName>Immuno-Chromogenic Reagent</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030708</emdnCode>
    <emdnDescription>STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFCP0005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:47:01.929Z</lastUpdated>
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    <udiDi>06979822870044</udiDi>
    <basicUdiDi>697982287IFCP0001C7</basicUdiDi>
    <tradeName>06979822870044</tradeName>
    <deviceName>Immuno-Chromogenic Reagent</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030708</emdnCode>
    <emdnDescription>STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFCP0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:46:48.159Z</lastUpdated>
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    <udiDi>06979822870037</udiDi>
    <basicUdiDi>697982287CFCP00018M</basicUdiDi>
    <tradeName>06979822870037</tradeName>
    <deviceName>Disposable Cell Filter</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029006</emdnCode>
    <emdnDescription>APHERESIS UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFCP0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:46:46.564Z</lastUpdated>
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    <udiDi>06979822870013</udiDi>
    <basicUdiDi>697982287IFCP0101CC</basicUdiDi>
    <tradeName>06979822870013</tradeName>
    <deviceName>Circulating epithelial cell detection kit</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030708</emdnCode>
    <emdnDescription>STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFCP0101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:46:45.759Z</lastUpdated>
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    <udiDi>06979822870006</udiDi>
    <basicUdiDi>697982287CSCP0001FJ</basicUdiDi>
    <tradeName>06979822870006</tradeName>
    <deviceName>Cell Sorter</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029006</emdnCode>
    <emdnDescription>APHERESIS UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTC100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:46:44.166Z</lastUpdated>
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    <udiDi>06979822870464</udiDi>
    <basicUdiDi>697982287CACP00015Y</basicUdiDi>
    <tradeName>06979822870464</tradeName>
    <deviceName>KRAS mutation and BMP3 NDRG4 methylation and fecal occult blood Kit</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CACP0001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:29:43.959Z</lastUpdated>
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    <udiDi>06979822870457</udiDi>
    <basicUdiDi>697982287GACP00018C</basicUdiDi>
    <tradeName>06979822870457</tradeName>
    <deviceName>Hepatocellular Carcinoma Methylation ddPCR Kit</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GACP0001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:29:42.755Z</lastUpdated>
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    <udiDi>06979822870440</udiDi>
    <basicUdiDi>697982287MCCP0001CY</basicUdiDi>
    <tradeName>06979822870440</tradeName>
    <deviceName>8 microRNAs qPCR Kit</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCCP0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:29:36.743Z</lastUpdated>
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    <udiDi>06979822870433</udiDi>
    <basicUdiDi>697982287MICP0001G6</basicUdiDi>
    <tradeName>06979822870433</tradeName>
    <deviceName>miR-92a ddPCR Kit</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MICP0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:29:35.538Z</lastUpdated>
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    <udiDi>06979822870426</udiDi>
    <basicUdiDi>697982287SECP0001HL</basicUdiDi>
    <tradeName>06979822870426</tradeName>
    <deviceName>Septin9 Methylation ddPCR Kit</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SECP0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:29:34.361Z</lastUpdated>
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    <udiDi>06979822870419</udiDi>
    <basicUdiDi>697982287STCP0001RK</basicUdiDi>
    <tradeName>06979822870419</tradeName>
    <deviceName>SDC2 TFPI2 Methylation ddPCR Kit</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STCP0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:29:33.142Z</lastUpdated>
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    <udiDi>06979822870402</udiDi>
    <basicUdiDi>697982287SCCP0001GJ</basicUdiDi>
    <tradeName>06979822870402</tradeName>
    <deviceName>SDC2 Methylation ddPCR Kit</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCCP0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:29:27.132Z</lastUpdated>
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    <udiDi>06979822870396</udiDi>
    <basicUdiDi>697982287TPCP0001Q2</basicUdiDi>
    <tradeName>06979822870396</tradeName>
    <deviceName>TP53 MUTATION ddPCR KIT</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPCP0001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:29:25.933Z</lastUpdated>
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    <udiDi>06979822870389</udiDi>
    <basicUdiDi>697982287BMHCP0001U6</basicUdiDi>
    <tradeName>06979822870389</tradeName>
    <deviceName>BRAF MET HER2 MUTATION ddPCR KI</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMHCP0001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:29:24.745Z</lastUpdated>
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    <udiDi>06979822870372</udiDi>
    <basicUdiDi>697982287DPICP0001XW</basicUdiDi>
    <tradeName>06979822870372</tradeName>
    <deviceName>PIK3CA MUTATION ddPCR KIT</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPICP0001</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:29:23.537Z</lastUpdated>
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    <udiDi>06979822870365</udiDi>
    <basicUdiDi>697982287DNSCP000145</basicUdiDi>
    <tradeName>06979822870365</tradeName>
    <deviceName>NRAS MUTATION ddPCR KIT</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNSCP0001</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:29:17.639Z</lastUpdated>
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