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    <tradeName>06975157920133</tradeName>
    <deviceName>Fully Automated Nucleic Acid Extraction System AutoPrep96</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-9601A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:17:43.314Z</lastUpdated>
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    <udiDi>06975157920102</udiDi>
    <basicUdiDi>697515792HBNP4803AJV</basicUdiDi>
    <tradeName>06975157920102</tradeName>
    <deviceName>Fully Automated Nucleic Acid Extraction System (AutoPrep)</deviceName>
    <manufacturerName>Hybribio Medtech Device Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBNP-4803A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:17:39.314Z</lastUpdated>
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    <udiDi>06975157920089</udiDi>
    <basicUdiDi>697515792HBNP4801AJP</basicUdiDi>
    <tradeName>06975157920089</tradeName>
    <deviceName>Fully Automated Nucleic Acid Extraction System (AutoPrep)</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-4801A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:17:38.515Z</lastUpdated>
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    <udiDi>06975157920065</udiDi>
    <basicUdiDi>697515792HBHM9000AE6</basicUdiDi>
    <tradeName>06975157920065</tradeName>
    <deviceName>Fully Automated Nucleic Acid Hybridization System (AutoMax)</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>W02050101</emdnCode>
    <emdnDescription>NUCLEIC ACID HYBRIDIZATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBHM-9000A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:17:36.916Z</lastUpdated>
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    <udiDi>06975157920058</udiDi>
    <basicUdiDi>697515792HBHM3001SDB</basicUdiDi>
    <tradeName>06975157920058</tradeName>
    <deviceName>Automated Nucleic Acid Hybridization System (mAutoMax)</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>W02050101</emdnCode>
    <emdnDescription>NUCLEIC ACID HYBRIDIZATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBHM-3001S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:17:34.514Z</lastUpdated>
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    <udiDi>06975157920034</udiDi>
    <basicUdiDi>697515792HB2012ADL</basicUdiDi>
    <tradeName>06975157920034</tradeName>
    <deviceName>Nucleic Acid Hybridization System for Medical use HybriMax 2</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>W02050101</emdnCode>
    <emdnDescription>NUCLEIC ACID HYBRIDIZATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB-2012A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:17:32.921Z</lastUpdated>
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    <udiDi>06975157920027</udiDi>
    <basicUdiDi>697515792HHM3PP</basicUdiDi>
    <tradeName>06975157920027</tradeName>
    <deviceName>DNA HybriMax</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>W02050101</emdnCode>
    <emdnDescription>NUCLEIC ACID HYBRIDIZATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HHM-3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:17:32.122Z</lastUpdated>
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    <udiDi>06975157920010</udiDi>
    <basicUdiDi>697515792HBQW3200AMD</basicUdiDi>
    <tradeName>06975157920010</tradeName>
    <deviceName>Automated Nucleic Acid Extraction and Amplification 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>HBQW-3200A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:17:30.505Z</lastUpdated>
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    <udiDi>06975121510162</udiDi>
    <basicUdiDi>697512151016GE</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction and Real-Time PCR System</tradeName>
    <deviceName>Automatic Nucleic Acid Extraction and Real-Time PCR System</deviceName>
    <manufacturerName>GuangDong Brightbiomed Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046979</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>AutoPlex-Min</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:13:14.946Z</lastUpdated>
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    <udiDi>06975121510155</udiDi>
    <basicUdiDi>697512151015GC</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction and Real-Time PCR System</tradeName>
    <deviceName>Automatic Nucleic Acid Extraction and Real-Time PCR System</deviceName>
    <manufacturerName>GuangDong Brightbiomed Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046979</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>AutoPlex-12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:13:14.138Z</lastUpdated>
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    <udiDi>06975102680013</udiDi>
    <basicUdiDi>697510268A001B2</basicUdiDi>
    <tradeName>06975102680013</tradeName>
    <deviceName>BJB Rapid Gene Detection System</deviceName>
    <manufacturerName>Jiangsu Bojia Biomedical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023653</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-1-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:09:29.079Z</lastUpdated>
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    <udiDi>06975061571612</udiDi>
    <basicUdiDi>697506157OPqPCR1600BL</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <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>06975050590204</udiDi>
    <basicUdiDi>697505059020JG</basicUdiDi>
    <tradeName>Full-Automatic Nucleic Acid Extraction and Purification Instrument</tradeName>
    <deviceName>Full-Automatic Nucleic Acid Extraction and Purification Instrument</deviceName>
    <manufacturerName>Jiangsu Q-Array Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044646</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>MN-9600B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:57:34.473Z</lastUpdated>
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    <udiDi>06975050590006</udiDi>
    <basicUdiDi>697505059000JA</basicUdiDi>
    <tradeName>Real-time Quantitative Thermal Cycler</tradeName>
    <deviceName>Real-time Quantitative Thermal Cycler</deviceName>
    <manufacturerName>Jiangsu Q-Array Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044646</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MA-688</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:57:33.668Z</lastUpdated>
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    <udiDi>06974968581090</udiDi>
    <basicUdiDi>697496858AH01FASTASeqSYL</basicUdiDi>
    <tradeName>GeneMind</tradeName>
    <deviceName>FASTASeq S Dx Sequencing System</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050108</emdnCode>
    <emdnDescription>GENETIC SYSTEM READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQ00078</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:47:44.183Z</lastUpdated>
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    <tradeName>GeneMind</tradeName>
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    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <emdnDescription>GENETIC SYSTEM READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQ00065</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:47:43.392Z</lastUpdated>
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    <tradeName>06974968581069</tradeName>
    <deviceName>SURFSeq 5000 Dx Sequencing System</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050108</emdnCode>
    <emdnDescription>GENETIC SYSTEM READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQ00026</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:47:41.836Z</lastUpdated>
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    <deviceName>Sequencing System</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050108</emdnCode>
    <emdnDescription>GENETIC SYSTEM READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQ00021</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:47:37.781Z</lastUpdated>
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    <deviceName>Sequencing System</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENETIC SYSTEM READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P000033</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:47:35.373Z</lastUpdated>
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