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    <tradeName>RNase P 384-Well Instrument Verification Plate</tradeName>
    <deviceName>RNase P Instrument Verification Plates, a part of Calibration and Verification Plates</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <lastUpdated>2026-07-15T19:49:29.052Z</lastUpdated>
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    <tradeName>Sentosa ST401i</tradeName>
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    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
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    <tradeName>Sentosa ST401e</tradeName>
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    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
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    <udiDi>08885013956207</udiDi>
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    <tradeName>Sentosa ST Template Kit (8)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
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    <udiDi>08885013956252</udiDi>
    <basicUdiDi>888501395SSQ301P2E</basicUdiDi>
    <tradeName>Sentosa SQ Sequencing Kit (8)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
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    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>690004</reference>
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    <udiDi>08885013956290</udiDi>
    <basicUdiDi>888501395SSQ301P2E</basicUdiDi>
    <tradeName>Sentosa SQ 318 Chip Kit (8)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300302</reference>
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    <lastUpdated>2026-07-08T07:19:18.491Z</lastUpdated>
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    <udiDi>09357795000038</udiDi>
    <basicUdiDi>93577950MicIVDG7</basicUdiDi>
    <tradeName>Mic IVD Automation</tradeName>
    <deviceName>Mic IVD</deviceName>
    <manufacturerName>Bio-Molecular Systems Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000025328</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIC-IVD AUTOMATION</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:08:12.085Z</lastUpdated>
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    <tradeName>RapiCycler 96 Real Time PCR System-(6-Channel)</tradeName>
    <deviceName>RapiCycler 96 Real Time PCR System-(6-Channel)</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2MRAPI4002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:00.298Z</lastUpdated>
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    <tradeName>RapiCycler 96 Real Time PCR System (4-Channel)</tradeName>
    <deviceName>RapiCycler 96 Real Time PCR System (4-Channel)</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2MRAPI4001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:52:59.498Z</lastUpdated>
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    <udiDi>08806133010471</udiDi>
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    <tradeName>IsoAmplar</tradeName>
    <deviceName>IsoAmplar</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPRR043</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:38:35.126Z</lastUpdated>
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    <udiDi>08800204300010</udiDi>
    <basicUdiDi>88002043RADIPREPSD</basicUdiDi>
    <tradeName>08800204300010</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:34:54.770Z</lastUpdated>
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    <udiDi>08800204301826</udiDi>
    <basicUdiDi>880002043ImmunoequipFH</basicUdiDi>
    <tradeName>TTÅniKoReader®</tradeName>
    <deviceName>TTÅniKoReader</deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:37.011Z</lastUpdated>
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    <udiDi>08684595039373</udiDi>
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    <tradeName>ChainPro™ Real-Time Fluorescence Quantitative PCR Instrument</tradeName>
    <deviceName>Real-Time Fluorescence Quantitative PCR Instrument</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGX16-4F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:38:12.875Z</lastUpdated>
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    <tradeName>ChainPro™ Real-Time Fluorescence Quantitative PCR Instrument</tradeName>
    <deviceName>Real-Time Fluorescence Quantitative PCR Instrument</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGX8-4F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:37:26.369Z</lastUpdated>
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    <tradeName>ChainPro™ Real-Time Fluorescence Quantitative PCR Instrument</tradeName>
    <deviceName>Real-Time Fluorescence Quantitative PCR Instrument</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGX8-2F</reference>
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    <lastUpdated>2026-07-03T15:37:25.589Z</lastUpdated>
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    <tradeName>Genomate</tradeName>
    <deviceName>Genomate workstation</deviceName>
    <manufacturerName>Genecast (Wuhan) Precision Diagnostic Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051330</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0100101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:37:20.349Z</lastUpdated>
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    <udiDi>06977334213014</udiDi>
    <basicUdiDi>697733421YJ300KJ</basicUdiDi>
    <tradeName>YJSeq 300 Dx Sequencing System</tradeName>
    <deviceName>YJSeq 300 Dx Sequencing System</deviceName>
    <manufacturerName>Shanghai YJMED BioTechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055692</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJSeq 300 Dx</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:26:28.318Z</lastUpdated>
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    <tradeName>Automatic Nucleic Acid Amplification Detection Analyzer</tradeName>
    <deviceName>Automatic Nucleic Acid Amplification Detection Analyzer</deviceName>
    <manufacturerName>Nanjing RainGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023111</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>030101CB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:19:04.298Z</lastUpdated>
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    <tradeName>06974884777713</tradeName>
    <deviceName>Multichannel Fluorescence Quantitative Analyzer</deviceName>
    <manufacturerName>Xi'an Tianlong Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001079</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y016B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:17.163Z</lastUpdated>
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    <tradeName>Easy Amp Real-time Fluorescence Isothermal Detection System</tradeName>
    <deviceName>Easy Amp Real-time Fluorescence Isothermal Detection System  (HWTS 1600)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-EQ002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:35.308Z</lastUpdated>
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