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    <basicUdiDi>697541263PCRSPB</basicUdiDi>
    <tradeName>Real-time PCR system</tradeName>
    <deviceName>Real-time PCR system</deviceName>
    <manufacturerName>Hangzhou Bio-gener Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027988</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q9602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:00:38.885Z</lastUpdated>
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    <udiDi>06975447581013</udiDi>
    <basicUdiDi>697544758GALAXYU9</basicUdiDi>
    <tradeName>Galaxy Nano</tradeName>
    <deviceName>Automated Fully Enclosed qPCR Instrument</deviceName>
    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001552</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0022-02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:00:26.077Z</lastUpdated>
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    <udiDi>06975409760012</udiDi>
    <basicUdiDi>6975409760005DD</basicUdiDi>
    <tradeName>06975409760012</tradeName>
    <deviceName>Real-time qPCR System</deviceName>
    <manufacturerName>Hangzhou LongGene Scientific Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024510</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q2000A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:55:02.353Z</lastUpdated>
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    <udiDi>06975352996049</udiDi>
    <basicUdiDi>697535299G1600196</basicUdiDi>
    <tradeName>Automated Workstation</tradeName>
    <deviceName>Automated Workstation</deviceName>
    <manufacturerName>Suzhou GenePlus Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035774</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB5001</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:44:43.045Z</lastUpdated>
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    <udiDi>06975352996018</udiDi>
    <basicUdiDi>697535299BOX001QB</basicUdiDi>
    <tradeName>Gene+Box Data Analysis and Management System</tradeName>
    <deviceName>Gene+Box Data Analysis and Management System</deviceName>
    <manufacturerName>Suzhou GenePlus Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035774</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050108</emdnCode>
    <emdnDescription>GENETIC SYSTEM READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED5001</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:44:42.369Z</lastUpdated>
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    <udiDi>06975337671015</udiDi>
    <basicUdiDi>697533767PCR001PH</basicUdiDi>
    <tradeName>Real-Time PCR System</tradeName>
    <deviceName>Real-Time PCR System</deviceName>
    <manufacturerName>Anhui Wanyi Science and Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039194</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:39:54.008Z</lastUpdated>
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    <udiDi>06975330320026</udiDi>
    <basicUdiDi>697533032MYNAPSSY</basicUdiDi>
    <tradeName>06975330320026</tradeName>
    <deviceName>Nucleic Acid Purification System</deviceName>
    <manufacturerName>Hangzhou MiYin Biotechnology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041649</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AUTO-MAGec 32</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:38:11.431Z</lastUpdated>
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    <udiDi>06975327120172</udiDi>
    <basicUdiDi>697532712PM008G5</basicUdiDi>
    <tradeName>Pluslife Dock Pro 8</tradeName>
    <deviceName>Eight-Channel POC Molecular Analyzer</deviceName>
    <manufacturerName>Guangzhou Pluslife Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025784</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM008</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:37:39.413Z</lastUpdated>
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    <udiDi>06975327120639</udiDi>
    <basicUdiDi>697532712PM001UFG</basicUdiDi>
    <tradeName>MiniDock Ultra</tradeName>
    <deviceName>Integrated Nucleic Acid Testing Device</deviceName>
    <manufacturerName>Guangzhou Pluslife Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025784</manufacturerSrn>
    <authorisedRepresentativeName>PureCE B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006069</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM001 Ultra</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:37:37.812Z</lastUpdated>
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    <udiDi>06975327120066</udiDi>
    <basicUdiDi>697532712PM001FP</basicUdiDi>
    <tradeName>Mini Dock</tradeName>
    <deviceName>Integrated Nucleic Acid Testing Device</deviceName>
    <manufacturerName>Guangzhou Pluslife Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025784</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:37:35.416Z</lastUpdated>
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    <udiDi>06975275770146</udiDi>
    <basicUdiDi>697527577004P3</basicUdiDi>
    <tradeName>Portable Nucleic  Acid Detection  Instrument</tradeName>
    <deviceName>Portable Nucleic  Acid Detection  Instrument</deviceName>
    <manufacturerName>Suzhou Molarray Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000053786</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAtriX-Mini</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:33:39.816Z</lastUpdated>
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    <udiDi>06975275770016</udiDi>
    <basicUdiDi>697527577001NV</basicUdiDi>
    <tradeName>Real-time Quantitative Thermal Cycler</tradeName>
    <deviceName>Real-time Quantitative Thermal Cycler</deviceName>
    <manufacturerName>Suzhou Molarray Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000053786</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MA-3200Q</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:33:37.407Z</lastUpdated>
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    <udiDi>06975275770139</udiDi>
    <basicUdiDi>697527577003NZ</basicUdiDi>
    <tradeName>Portable Nucleic  Acid Testing Box</tradeName>
    <deviceName>Portable Nucleic  Acid Testing Box</deviceName>
    <manufacturerName>Suzhou Molarray Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000053786</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Mini-Cube</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:33:35.805Z</lastUpdated>
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    <udiDi>06975275770023</udiDi>
    <basicUdiDi>697527577002NX</basicUdiDi>
    <tradeName>Full-Automatic  Nucleic Acid  Extraction and  qPCR Analysis  System</tradeName>
    <deviceName>Full-Automatic  Nucleic Acid  Extraction and  qPCR Analysis  System</deviceName>
    <manufacturerName>Suzhou Molarray Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000053786</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MW-1600BL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:33:35.002Z</lastUpdated>
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    <udiDi>06975196540088</udiDi>
    <basicUdiDi>697519654829QC</basicUdiDi>
    <tradeName>06975196540088</tradeName>
    <deviceName>Isothermal Nucleic Acid Amplification Detector</deviceName>
    <manufacturerName>Wuxi Qitian Biological Science Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023012</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>829</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:24:18.199Z</lastUpdated>
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    <udiDi>06975196540057</udiDi>
    <basicUdiDi>697519654828QA</basicUdiDi>
    <tradeName>06975196540057</tradeName>
    <deviceName>Isothermal Amplification Fluorescence Detector</deviceName>
    <manufacturerName>Wuxi Qitian Biological Science Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023012</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>828</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:24:13.401Z</lastUpdated>
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    <udiDi>06975178390038</udiDi>
    <basicUdiDi>697517839AutoNAADAQ2</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>AB pazarı için değil</deviceStatus>
    <reference>030101CB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:19:04.298Z</lastUpdated>
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    <udiDi>06975157920225</udiDi>
    <basicUdiDi>697515792HBNPME32AW5</basicUdiDi>
    <tradeName>06975157920225</tradeName>
    <deviceName>Fully Automated Nucleic Acid Extraction and Conversion System</deviceName>
    <manufacturerName>Hybribio Medtech Device Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBNP-ME32A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:18:05.783Z</lastUpdated>
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    <udiDi>06975157920218</udiDi>
    <basicUdiDi>697515792HBIEX96SBY</basicUdiDi>
    <tradeName>06975157920218</tradeName>
    <deviceName>Fully Automated Sample Preparation Liquid Handling System</deviceName>
    <manufacturerName>Hybribio Medtech Device Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-IEX96S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:18:01.075Z</lastUpdated>
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    <udiDi>06975157920164</udiDi>
    <basicUdiDi>697515792HBIEX96AAU</basicUdiDi>
    <tradeName>06975157920164</tradeName>
    <deviceName>Fully Automated Sample Preparation Liquid Handling System</deviceName>
    <manufacturerName>Hybribio Medtech Device Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-IEX96A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:17:45.722Z</lastUpdated>
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