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    <deviceName>Mpox Virus Nucleic Acid Detection Kit（Fluorescent RAA)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F03006A-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:09.615Z</lastUpdated>
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    <deviceName>Mpox Virus Nucleic Acid Detection Kit（Fluorescent RAA)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
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    <lastUpdated>2026-07-06T18:58:08.803Z</lastUpdated>
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    <deviceName>Mpox Virus Nucleic Acid Detection Kit（Fluorescent RAA)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T18:58:08.012Z</lastUpdated>
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    <udiDi>06975102440952</udiDi>
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    <deviceName>SARS-CoV-2 Nucleic Acid Detection Kit</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>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:07.209Z</lastUpdated>
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    <udiDi>06975102440891</udiDi>
    <basicUdiDi>B-06975102440891</basicUdiDi>
    <tradeName>06975102440891</tradeName>
    <deviceName>COVID-19 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>
    <legislation>IVDD</legislation>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F02R13AIV-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:03.203Z</lastUpdated>
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    <udiDi>06975102440884</udiDi>
    <basicUdiDi>B-06975102440884</basicUdiDi>
    <tradeName>06975102440884</tradeName>
    <deviceName>COVID-19 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>F02R13AIV-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:02.400Z</lastUpdated>
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    <udiDi>06975102440877</udiDi>
    <basicUdiDi>B-06975102440877</basicUdiDi>
    <tradeName>06975102440877</tradeName>
    <deviceName>COVID-19 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>
    <legislation>IVDD</legislation>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F02R13AIV-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:01.603Z</lastUpdated>
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    <udiDi>06975102440860</udiDi>
    <basicUdiDi>B-06975102440860</basicUdiDi>
    <tradeName>06975102440860</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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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01009A-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:00.801Z</lastUpdated>
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    <udiDi>06975102440853</udiDi>
    <basicUdiDi>B-06975102440853</basicUdiDi>
    <tradeName>06975102440853</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>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01009A-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <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>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <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>F01009A-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:55.991Z</lastUpdated>
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    <udiDi>06975102440839</udiDi>
    <basicUdiDi>B-06975102440839</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <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>F01008A-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:55.194Z</lastUpdated>
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    <udiDi>06975102440822</udiDi>
    <basicUdiDi>B-06975102440822</basicUdiDi>
    <tradeName>06975102440822</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>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01008A-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:54.396Z</lastUpdated>
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    <udiDi>06975102440815</udiDi>
    <basicUdiDi>B-06975102440815</basicUdiDi>
    <tradeName>06975102440815</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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    <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>F01008A-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:50.392Z</lastUpdated>
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    <udiDi>06975102440808</udiDi>
    <basicUdiDi>B-06975102440808</basicUdiDi>
    <tradeName>06975102440808</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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    <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>
    <basicUdiDi>B-06975102440785</basicUdiDi>
    <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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    <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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    <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>
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    <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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    <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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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <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>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:27.930Z</lastUpdated>
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    <basicUdiDi>B-06975102440747</basicUdiDi>
    <tradeName>06975102440747</tradeName>
    <deviceName>Enterobacter Sakazakii 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>F01003A-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:27.129Z</lastUpdated>
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