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    <manufacturerName>Cube Dx GmbH</manufacturerName>
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    <tradeName>hyborg Dx RED2</tradeName>
    <deviceName>hyborg Dx RED2</deviceName>
    <manufacturerName>Cube Dx GmbH</manufacturerName>
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    <lastUpdated>2026-07-31T21:42:26.488Z</lastUpdated>
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    <udiDi>08885019711121</udiDi>
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    <tradeName>08885019711121</tradeName>
    <deviceName>abONE™ Automated MDx System</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <deviceName>abSEQ™ Genetic Sequencer</deviceName>
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    <deviceName>abCycler™Q Real-time PCR System</deviceName>
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    <tradeName>Sentosa SQ301 Sequencer</tradeName>
    <deviceName>Sentosa SQ301 Platform</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>400103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:08:50.206Z</lastUpdated>
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    <tradeName>GT NUCLEIC ACID PREP KIT</tradeName>
    <deviceName>GT NUCLEIC ACID PREP KIT</deviceName>
    <manufacturerName>Genomictree, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000037890</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GT-PREP-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:04:25.772Z</lastUpdated>
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    <tradeName>NGSengine®</tradeName>
    <deviceName>NGSengine</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4949940, 4949740, 4949840, 4949640</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:44:32.748Z</lastUpdated>
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    <tradeName>croGENE Real-Time PCR System</tradeName>
    <deviceName>croGENE Real-Time PCR System</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGRT6/96</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:17:37.062Z</lastUpdated>
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    <tradeName>MH Guide</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Molecular Health GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012861</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1000000141</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:55:18.469Z</lastUpdated>
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    <tradeName>MH Guide</tradeName>
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    <manufacturerName>Molecular Health GmbH</manufacturerName>
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    <tradeName>VIPER</tradeName>
    <deviceName>BD Viper™ LT System</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
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    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <deviceName>Automatic Nucleic Acid Purification Instrument</deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
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    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
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    <deviceName>Real-time Fluorescent Quantitative PCR Analyzer</deviceName>
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    <lastUpdated>2026-07-31T18:44:48.127Z</lastUpdated>
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    <tradeName>Sanity 2.0 System</tradeName>
    <deviceName>Fully Automated Medical PCR Analysis System</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
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    <tradeName>Nucleic Acid Extraction System</tradeName>
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    <tradeName>Automatic Integrated Nucleic Acid Analyzer</tradeName>
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    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
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    <lastUpdated>2026-07-31T17:29:07.482Z</lastUpdated>
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