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    <basicUdiDi>8905459RNAEXTAU</basicUdiDi>
    <tradeName>08905459001368</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBRIKG-01 MBRIKG-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:32.356Z</lastUpdated>
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    <udiDi>06975166200233</udiDi>
    <basicUdiDi>B-06975166200233</basicUdiDi>
    <tradeName>06975166200233</tradeName>
    <deviceName>Monkeypox Virus DNA Detection Kit (Real-Time PCR)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</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>96 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:57.988Z</lastUpdated>
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    <udiDi>06975166200226</udiDi>
    <basicUdiDi>B-06975166200226</basicUdiDi>
    <tradeName>06975166200226</tradeName>
    <deviceName>Monkeypox Virus DNA Detection Kit (Real-Time PCR)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</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>48 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:53.976Z</lastUpdated>
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    <udiDi>06975166200219</udiDi>
    <basicUdiDi>B-06975166200219</basicUdiDi>
    <tradeName>06975166200219</tradeName>
    <deviceName>Monkeypox Virus DNA Detection Kit (Real-Time PCR)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</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>24 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:53.191Z</lastUpdated>
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    <udiDi>06975146603665</udiDi>
    <basicUdiDi>B-06975146603665</basicUdiDi>
    <tradeName>06975146603665</tradeName>
    <deviceName>Monkeypox Virus Molecular Diagnostic Kit (Fluorescent PCR Test) (Lyophilized)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:16.304Z</lastUpdated>
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    <udiDi>06975146600039</udiDi>
    <basicUdiDi>B-06975146600039</basicUdiDi>
    <tradeName>06975146600039</tradeName>
    <deviceName>2019-nCoV Molecular Diagnostic Kit(Fluorescent PCR Test)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:50.681Z</lastUpdated>
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    <udiDi>06975102441072</udiDi>
    <basicUdiDi>B-06975102441072</basicUdiDi>
    <tradeName>06975102441072</tradeName>
    <deviceName>Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-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>
    <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>F03R10AⅢ-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:26.417Z</lastUpdated>
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    <udiDi>06975102441065</udiDi>
    <basicUdiDi>B-06975102441065</basicUdiDi>
    <tradeName>06975102441065</tradeName>
    <deviceName>Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-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>
    <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>F03R10AⅢ-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:22.410Z</lastUpdated>
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    <udiDi>06975102441058</udiDi>
    <basicUdiDi>B-06975102441058</basicUdiDi>
    <tradeName>06975102441058</tradeName>
    <deviceName>Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-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>
    <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>F03R10AⅢ-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:21.609Z</lastUpdated>
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    <udiDi>06975102441041</udiDi>
    <basicUdiDi>B-06975102441041</basicUdiDi>
    <tradeName>06975102441041</tradeName>
    <deviceName>Schistosoma Mansoni 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>
    <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>F06005A-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:20.813Z</lastUpdated>
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    <udiDi>06975102441034</udiDi>
    <basicUdiDi>B-06975102441034</basicUdiDi>
    <tradeName>06975102441034</tradeName>
    <deviceName>Schistosoma Mansoni 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>
    <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>F06005A-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:20.024Z</lastUpdated>
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    <udiDi>06975102441027</udiDi>
    <basicUdiDi>B-06975102441027</basicUdiDi>
    <tradeName>06975102441027</tradeName>
    <deviceName>Schistosoma Mansoni 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>
    <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>F06005A-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:16.007Z</lastUpdated>
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    <udiDi>06975102441010</udiDi>
    <basicUdiDi>B-06975102441010</basicUdiDi>
    <tradeName>06975102441010</tradeName>
    <deviceName>Schistosoma Haematobium 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>
    <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>F06004A-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:15.209Z</lastUpdated>
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    <udiDi>06975102441003</udiDi>
    <basicUdiDi>B-06975102441003</basicUdiDi>
    <tradeName>06975102441003</tradeName>
    <deviceName>Schistosoma Haematobium 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>
    <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>F06004A-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:14.406Z</lastUpdated>
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    <udiDi>06975102440990</udiDi>
    <basicUdiDi>B-06975102440990</basicUdiDi>
    <tradeName>06975102440990</tradeName>
    <deviceName>Schistosoma Haematobium 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>
    <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>F06004A-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:13.611Z</lastUpdated>
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    <udiDi>06975102440983</udiDi>
    <basicUdiDi>B-06975102440983</basicUdiDi>
    <tradeName>06975102440983</tradeName>
    <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>
    <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>F03006A-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:09.615Z</lastUpdated>
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    <udiDi>06975102440976</udiDi>
    <basicUdiDi>B-06975102440976</basicUdiDi>
    <tradeName>06975102440976</tradeName>
    <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>
    <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>F03006A-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:08.803Z</lastUpdated>
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    <udiDi>06975102440969</udiDi>
    <basicUdiDi>B-06975102440969</basicUdiDi>
    <tradeName>06975102440969</tradeName>
    <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>
    <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>F03006A-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:08.012Z</lastUpdated>
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    <udiDi>06975102440952</udiDi>
    <basicUdiDi>B-06975102440952</basicUdiDi>
    <tradeName>06975102440952</tradeName>
    <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>
    <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>/</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>
    <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>F02R13AIV-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:58:03.203Z</lastUpdated>
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