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    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
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    <lastUpdated>2026-07-06T18:58:02.400Z</lastUpdated>
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    <deviceName>COVID-19 Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
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    <deviceName>Vibrio Cholerae Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
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    <deviceName>Vibrio Cholerae Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
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    <lastUpdated>2026-07-06T18:57:56.803Z</lastUpdated>
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    <udiDi>06975102440846</udiDi>
    <basicUdiDi>B-06975102440846</basicUdiDi>
    <tradeName>06975102440846</tradeName>
    <deviceName>Vibrio Cholerae Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <udiDi>06975102440839</udiDi>
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    <tradeName>06975102440839</tradeName>
    <deviceName>Brucella Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
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    <lastUpdated>2026-07-06T18:57:55.194Z</lastUpdated>
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    <deviceName>Brucella Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>Brucella Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:50.392Z</lastUpdated>
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    <deviceName>Listeria Monocytogenes Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01006A-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:49.600Z</lastUpdated>
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    <udiDi>06975102440792</udiDi>
    <basicUdiDi>B-06975102440792</basicUdiDi>
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    <deviceName>Listeria Monocytogenes Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01006A-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:48.789Z</lastUpdated>
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    <udiDi>06975102440785</udiDi>
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    <tradeName>06975102440785</tradeName>
    <deviceName>Listeria Monocytogenes Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01006A-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:47.988Z</lastUpdated>
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    <udiDi>06975102440778</udiDi>
    <basicUdiDi>B-06975102440778</basicUdiDi>
    <tradeName>06975102440778</tradeName>
    <deviceName>Vibrio Parahemolyticus Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
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    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01004A-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:32.738Z</lastUpdated>
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    <tradeName>06975102440761</tradeName>
    <deviceName>Vibrio Parahemolyticus Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01004A-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:31.935Z</lastUpdated>
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    <deviceName>Vibrio Parahemolyticus Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01004A-96</reference>
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    <lastUpdated>2026-07-06T18:57:27.930Z</lastUpdated>
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    <deviceName>Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
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    <deviceName>Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
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    <deviceName>Enterobacter Sakazakii Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
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    <deviceName>Staphylococcus Aureus Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
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    <deviceName>Staphylococcus Aureus Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
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    <deviceName>Staphylococcus Aureus Nucleic Acid Detection Kit（Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01002A-96</reference>
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