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    <deviceName>FastFinder Platform</deviceName>
    <manufacturerName>UgenTec</manufacturerName>
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    <tradeName>VELA Analytics</tradeName>
    <deviceName>VELA Analytics</deviceName>
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    <deviceName>Sentosa SQ Reporter Software</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
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    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
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    <udiDi>D-484985147</udiDi>
    <basicUdiDi>B-484985147</basicUdiDi>
    <tradeName>KMRengine® Premium Entry (5 years)</tradeName>
    <deviceName>KMRengine® Premium Entry (5 years)</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
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    <lastUpdated>2026-07-11T17:17:39.085Z</lastUpdated>
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    <tradeName>KMRengine® Standard Extension (+1 year)</tradeName>
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    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
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    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
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    <tradeName>InfectID-Client Software</tradeName>
    <deviceName>InfectID-Client Software</deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
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    <reference>V1.1</reference>
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    <lastUpdated>2026-07-10T19:37:54.657Z</lastUpdated>
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    <basicUdiDi>B-08436566763219</basicUdiDi>
    <tradeName>Genesystems© Genebytes</tradeName>
    <deviceName>Genesystems© Genebytes</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4827</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:29.547Z</lastUpdated>
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    <deviceName>Genesystems© – G-PRECON</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <reference>LV4826</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:27.907Z</lastUpdated>
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    <udiDi>08436566763196</udiDi>
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    <tradeName>Genesystems G-NIPT</tradeName>
    <deviceName>Genesystems© G-NIPT</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Ek II Liste B</riskClass>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4825</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:27.107Z</lastUpdated>
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    <udiDi>06974968584091</udiDi>
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    <tradeName>GeneMind</tradeName>
    <deviceName>Respiratory Pathogen Nucleic Acid Detection Analysis Software</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000124</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:08:18.621Z</lastUpdated>
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    <udiDi>06974968584077</udiDi>
    <basicUdiDi>B-06974968584077</basicUdiDi>
    <tradeName>GeneMind</tradeName>
    <deviceName>Analysis Software for Drug Resistance Detection in Tuberculosis</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000121</reference>
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    <lastUpdated>2026-07-06T18:08:16.337Z</lastUpdated>
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    <tradeName>Whole Genome  Copy Number Variation Analysis Software</tradeName>
    <deviceName>Whole Genome  Copy Number Variation Analysis Software</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <tradeName>GeneMind</tradeName>
    <deviceName>Preimplantation Genetic Testing for Aneuploidies Analysis Software</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
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    <tradeName>Fetal Chromosome Aneuploidy Analysis Software</tradeName>
    <deviceName>Fetal Chromosome Aneuploidy Analysis Software</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
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    <tradeName>Genexpath</tradeName>
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    <manufacturerName>Genexpath</manufacturerName>
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    <deviceName>KRAS Gene Mutation, BMP3/NDRG4 Gene Methylation and FIT Combined Detection Analysis Software</deviceName>
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