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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>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
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    <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>F01003A-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:26.328Z</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>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01003A-96</reference>
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    <lastUpdated>2026-07-06T18:57:25.532Z</lastUpdated>
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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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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
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    <udiDi>06975102440709</udiDi>
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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>
    <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>F01002A-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:20.734Z</lastUpdated>
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    <udiDi>06975102440693</udiDi>
    <basicUdiDi>B-06975102440693</basicUdiDi>
    <tradeName>06975102440693</tradeName>
    <deviceName>Staphylococcus Aureus 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>F01002A-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:19.929Z</lastUpdated>
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    <udiDi>06975102440686</udiDi>
    <basicUdiDi>B-06975102440686</basicUdiDi>
    <tradeName>06975102440686</tradeName>
    <deviceName>Salmonella 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>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01001A-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:19.131Z</lastUpdated>
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    <udiDi>06975102440679</udiDi>
    <basicUdiDi>B-06975102440679</basicUdiDi>
    <tradeName>06975102440679</tradeName>
    <deviceName>Salmonella 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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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01001A-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:15.128Z</lastUpdated>
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    <udiDi>06975102440662</udiDi>
    <basicUdiDi>B-06975102440662</basicUdiDi>
    <tradeName>06975102440662</tradeName>
    <deviceName>Salmonella 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>F01001A-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:14.327Z</lastUpdated>
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    <udiDi>06975102440655</udiDi>
    <basicUdiDi>B-06975102440655</basicUdiDi>
    <tradeName>06975102440655</tradeName>
    <deviceName>Ebola virus 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>F03R21A-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:13.529Z</lastUpdated>
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    <udiDi>06975102440648</udiDi>
    <basicUdiDi>B-06975102440648</basicUdiDi>
    <tradeName>06975102440648</tradeName>
    <deviceName>Ebola virus 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>F03R21A-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:12.727Z</lastUpdated>
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    <udiDi>06975102440631</udiDi>
    <basicUdiDi>B-06975102440631</basicUdiDi>
    <tradeName>06975102440631</tradeName>
    <deviceName>Ebola virus 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>F03R21A-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:07.925Z</lastUpdated>
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    <udiDi>06975102440624</udiDi>
    <basicUdiDi>B-06975102440624</basicUdiDi>
    <tradeName>06975102440624</tradeName>
    <deviceName>Bacillus anthracis 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>F03020A-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:07.123Z</lastUpdated>
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    <udiDi>06975102440617</udiDi>
    <basicUdiDi>B-06975102440617</basicUdiDi>
    <tradeName>06975102440617</tradeName>
    <deviceName>Bacillus anthracis 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>F03020A-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:06.334Z</lastUpdated>
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    <udiDi>06975102440600</udiDi>
    <basicUdiDi>B-06975102440600</basicUdiDi>
    <tradeName>06975102440600</tradeName>
    <deviceName>Bacillus anthracis 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>F03020A-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:05.517Z</lastUpdated>
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    <udiDi>06975102440594</udiDi>
    <basicUdiDi>B-06975102440594</basicUdiDi>
    <tradeName>06975102440594</tradeName>
    <deviceName>Yersinia Pestis  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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    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F03019A-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:01.519Z</lastUpdated>
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    <udiDi>06975102440587</udiDi>
    <basicUdiDi>B-06975102440587</basicUdiDi>
    <tradeName>06975102440587</tradeName>
    <deviceName>Yersinia Pestis  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>F03019A-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:57:00.715Z</lastUpdated>
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    <basicUdiDi>B-06975102440570</basicUdiDi>
    <tradeName>06975102440570</tradeName>
    <deviceName>Yersinia Pestis  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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    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F03019A-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:56:59.917Z</lastUpdated>
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    <udiDi>06975102440563</udiDi>
    <basicUdiDi>B-06975102440563</basicUdiDi>
    <tradeName>06975102440563</tradeName>
    <deviceName>Plasmodium 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>F03014A-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:56:59.117Z</lastUpdated>
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    <udiDi>06975102440556</udiDi>
    <basicUdiDi>B-06975102440556</basicUdiDi>
    <tradeName>06975102440556</tradeName>
    <deviceName>Plasmodium 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>F03014A-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:56:54.314Z</lastUpdated>
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    <tradeName>06975102440549</tradeName>
    <deviceName>Plasmodium 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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    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F03014A-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:56:53.513Z</lastUpdated>
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