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    <deviceName>Fully Automated PCR Detection System</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
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    <tradeName>Hand-held Nucleic Acid Detection Analyzer</tradeName>
    <deviceName>Hand-held Nucleic Acid Detection Analyzer</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
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    <tradeName>Real-time PCR Nucleic Acid Detection System</tradeName>
    <deviceName>Real-time PCR Nucleic Acid Detection System</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
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    <tradeName>PCR Nucleic Acid Analyzer</tradeName>
    <deviceName>PCR Nucleic Acid Analyzer</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWM-01</reference>
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    <lastUpdated>2026-07-02T14:40:26.066Z</lastUpdated>
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    <udiDi>06974884777904</udiDi>
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    <deviceName>PCR Thermal Cycler</deviceName>
    <manufacturerName>Xi'an Tianlong Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001079</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>Y007H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:24.363Z</lastUpdated>
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    <deviceName>All-in-one Molecular Diagnosis System</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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    <deviceName>Multichannel Fluorescence Quantitative Analyzer</deviceName>
    <manufacturerName>Xi'an Tianlong Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001079</manufacturerSrn>
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    <reference>Y016B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:17.163Z</lastUpdated>
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    <deviceName>Automatic Nucleic Acid Workstation</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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    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y064H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:15.564Z</lastUpdated>
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    <deviceName>Automated Nucleic Acid Extraction System</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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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y068H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:11.554Z</lastUpdated>
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    <tradeName>Nucleic Acid Extraction System</tradeName>
    <deviceName>Automatic Nucleic Acid Extractor</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>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y005H-KG-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:04.397Z</lastUpdated>
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    <deviceName>Real-time PCR System</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>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y034H-KG-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:03.550Z</lastUpdated>
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    <deviceName>Real-time PCR System</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>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TL59BRH</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:02.758Z</lastUpdated>
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    <deviceName>Automatic Nucleic Acid Extractor</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>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y963H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:38:43.473Z</lastUpdated>
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    <tradeName>Genetic Sequencer DNBSEQ-E25</tradeName>
    <deviceName>Genetic Sequencer</deviceName>
    <manufacturerName>Qingdao MGI Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022546</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnDescription>GENETIC SYSTEM READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-000850-00</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:37:15.357Z</lastUpdated>
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    <tradeName>Easy Amp Real-time Fluorescence Isothermal Detection System</tradeName>
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    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:35.308Z</lastUpdated>
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    <deviceName>Automatic Nucleic Acid Extractor</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
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    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ArchiPure 96 Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:29:33.933Z</lastUpdated>
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    <deviceName>Real-Time PCR System</deviceName>
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    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
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    <reference>Archimed Mini 16</reference>
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    <lastUpdated>2026-07-02T14:29:28.337Z</lastUpdated>
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    <deviceName>Real-Time PCR System</deviceName>
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    <lastUpdated>2026-07-02T14:29:27.540Z</lastUpdated>
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    <deviceName>Real-Time PCR System</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-02T14:29:26.730Z</lastUpdated>
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    <deviceName>Automatic Nucleic Acid Detection and Analysis System</deviceName>
    <manufacturerName>Shanghai Rendu Biotechnology Co., Ltd.</manufacturerName>
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    <reference>AutoSAT</reference>
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    <lastUpdated>2026-07-02T14:23:09.351Z</lastUpdated>
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