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    <tradeName>Droplex POLE Mutation Test v2</tradeName>
    <deviceName>Droplex POLE Mutation Test v2</deviceName>
    <manufacturerName>Gencurix, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000034097</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD025</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:32:49.981Z</lastUpdated>
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    <udiDi>08800087700167</udiDi>
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    <tradeName>Droplex cMET Exon14 Skipping Test</tradeName>
    <deviceName>Droplex cMET Exon14 Skipping Test</deviceName>
    <manufacturerName>Gencurix, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000034097</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-01T02:32:47.601Z</lastUpdated>
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    <udiDi>08800087700075</udiDi>
    <basicUdiDi>88000877BRV0CD00565</basicUdiDi>
    <tradeName>Droplex BRAF Mutation Test</tradeName>
    <deviceName>Droplex BRAF Mutation Test</deviceName>
    <manufacturerName>Gencurix, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000034097</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:32:46.402Z</lastUpdated>
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    <udiDi>08720211482212</udiDi>
    <basicUdiDi>872021148P35266</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P352 PKD1-PKD2</tradeName>
    <deviceName>SALSA MLPA Probemix P352 PKD1-PKD2</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P352-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:09.449Z</lastUpdated>
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    <udiDi>80593864302626</udiDi>
    <basicUdiDi>805938643SBGKLV</basicUdiDi>
    <tradeName>STAR BEADS GENOMIC DNA EXTRACTION KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CYANAGEN Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000038227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SBK261,2X32PFI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:48:10.118Z</lastUpdated>
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    <udiDi>80593864302794</udiDi>
    <basicUdiDi>805938643SBGKLV</basicUdiDi>
    <tradeName>STAR BEADS GENOMIC DNA EXTRACTION KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CYANAGEN Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000038227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SBK265,1X10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:47:15.032Z</lastUpdated>
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    <basicUdiDi>805938643SBGKLV</basicUdiDi>
    <tradeName>STAR BEADS GENOMIC DNA EXTRACTION KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CYANAGEN Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000038227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SBK287,1X96PFI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:47:13.278Z</lastUpdated>
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    <udiDi>06979822870464</udiDi>
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    <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>
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    <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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    <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>
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    <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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    <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>
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    <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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    <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>
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    <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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    <deviceName>KRAS MUTATION ddPCR KIT</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DKCP0001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:29:15.128Z</lastUpdated>
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    <basicUdiDi>697982287DECP00028R</basicUdiDi>
    <tradeName>06979822870020</tradeName>
    <deviceName>EGFR MUTATION ddPCR KIT</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DECP0002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:29:12.726Z</lastUpdated>
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