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    <tradeName>Real-time Fluorescence Quantitative PCR lnstrument</tradeName>
    <deviceName>Real-time fluorecence quantitatine PCR instrument</deviceName>
    <manufacturerName>Wuxi Opulen Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023008</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>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:59:41.898Z</lastUpdated>
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    <udiDi>06975061571605</udiDi>
    <basicUdiDi>697506157OPqPCR1600C65</basicUdiDi>
    <tradeName>Real time fluorescence quantitative PCR  Device</tradeName>
    <deviceName>Real time fluorescence quantitative PCR Device</deviceName>
    <manufacturerName>Wuxi Opulen Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023008</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1722023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:59:40.270Z</lastUpdated>
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    <udiDi>06974944990007</udiDi>
    <basicUdiDi>697494499000RD</basicUdiDi>
    <tradeName>All-in-one Digital PCR Device</tradeName>
    <deviceName>All-in-one Digital PCR Device</deviceName>
    <manufacturerName>Suzhou Sniper Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017448</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DQ24-Dx</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:46:08.058Z</lastUpdated>
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    <udiDi>06974884777904</udiDi>
    <basicUdiDi>697488477TLH003YT</basicUdiDi>
    <tradeName>06974884777904</tradeName>
    <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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    <udiDi>06974884777638</udiDi>
    <basicUdiDi>697488477TLH004YV</basicUdiDi>
    <tradeName>06974884777638</tradeName>
    <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>
    <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>Y064H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:15.564Z</lastUpdated>
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    <udiDi>06974884777560</udiDi>
    <basicUdiDi>697488477TLH017Z6</basicUdiDi>
    <tradeName>06974884777560</tradeName>
    <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>
    <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>Y068H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:11.554Z</lastUpdated>
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    <basicUdiDi>697488477TLH002YR</basicUdiDi>
    <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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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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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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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <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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    <udiDi>06974884776334</udiDi>
    <basicUdiDi>697488477TLH015Z2</basicUdiDi>
    <tradeName>06974884776334</tradeName>
    <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>
    <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>TL59BRH</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:02.758Z</lastUpdated>
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    <udiDi>06974884776198</udiDi>
    <basicUdiDi>697488477TLH019ZA</basicUdiDi>
    <tradeName>06974884776198</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>
    <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>Y963H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:38:43.473Z</lastUpdated>
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    <udiDi>06974795551068</udiDi>
    <basicUdiDi>6974795551006GY</basicUdiDi>
    <tradeName>06974795551068</tradeName>
    <deviceName>Automatic Nucleic Acid Extractor</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</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>ArchiPure 96 Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:29:33.933Z</lastUpdated>
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    <udiDi>06974591041145</udiDi>
    <basicUdiDi>6974591041006B2</basicUdiDi>
    <tradeName>06974591041145</tradeName>
    <deviceName>Automatic Nucleic Acid Extraction Instrument</deviceName>
    <manufacturerName>Creative Biosciences (Guangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034058</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>H24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:40:04.923Z</lastUpdated>
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    <udiDi>06974454727308</udiDi>
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    <tradeName>06974454727308</tradeName>
    <deviceName>Automatic Nucleic Acid Extractor</deviceName>
    <manufacturerName>Jiangsu CoWin Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008981</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>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CWX901</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:10:02.496Z</lastUpdated>
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    <basicUdiDi>697414986027NA</basicUdiDi>
    <tradeName>06974149860068</tradeName>
    <deviceName>qMate Mini Nucleic Acid Extraction System</deviceName>
    <manufacturerName>Aperbio  Technologies  (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000045149</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H691101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:29:04.628Z</lastUpdated>
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    <udiDi>06973698770378</udiDi>
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    <tradeName>Nucleic Acid Extractor System</tradeName>
    <deviceName>Nucleic Acid Extractor System</deviceName>
    <manufacturerName>Guangzhou Four E’s Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023274</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MultiEx 096</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:58:06.806Z</lastUpdated>
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    <tradeName>Nucleic Acid Extractor System</tradeName>
    <deviceName>Nucleic Acid Extractor System</deviceName>
    <manufacturerName>Guangzhou Four E’s Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023274</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MultiEx 032</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:58:06.010Z</lastUpdated>
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    <udiDi>06926802605639</udiDi>
    <basicUdiDi>69268026GeneXE600000001P2</basicUdiDi>
    <tradeName>AutoMated Nucleic Acid Extraction System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GeneX E6s</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:34:09.426Z</lastUpdated>
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    <tradeName>EZ2 Connect MDx</tradeName>
    <deviceName>EZ2 Connect MDx</deviceName>
    <manufacturerName>QIAGEN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9003230</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:23:16.315Z</lastUpdated>
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    <tradeName>QIAcube Connect MDx</tradeName>
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    <manufacturerName>QIAGEN GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9003070</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:23:12.308Z</lastUpdated>
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    <tradeName>RADIONE 4ch</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>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T22:40:07.823Z</lastUpdated>
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