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    <basicUdiDi>B-06975146600206</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00305</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:01:03.482Z</lastUpdated>
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    <udiDi>06975146600190</udiDi>
    <basicUdiDi>B-06975146600190</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00205</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:59.491Z</lastUpdated>
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    <udiDi>06975146600183</udiDi>
    <basicUdiDi>B-06975146600183</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00205</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:58.684Z</lastUpdated>
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    <udiDi>06975146600176</udiDi>
    <basicUdiDi>B-06975146600176</basicUdiDi>
    <tradeName>06975146600176</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00205</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:57.899Z</lastUpdated>
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    <udiDi>06975146600169</udiDi>
    <basicUdiDi>B-06975146600169</basicUdiDi>
    <tradeName>06975146600169</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00101</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:57.080Z</lastUpdated>
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  <row>
    <udiDi>06975146600152</udiDi>
    <basicUdiDi>B-06975146600152</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00120</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:53.066Z</lastUpdated>
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    <udiDi>06975146600145</udiDi>
    <basicUdiDi>B-06975146600145</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00101</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:52.287Z</lastUpdated>
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  <row>
    <udiDi>06975146600138</udiDi>
    <basicUdiDi>B-06975146600138</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00101</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:00:51.497Z</lastUpdated>
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    <udiDi>06974858561379</udiDi>
    <basicUdiDi>B-06974858561379</basicUdiDi>
    <tradeName>Nipah Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P6087H</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:00:11.406Z</lastUpdated>
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    <udiDi>06974854620834</udiDi>
    <basicUdiDi>B-06974854620834</basicUdiDi>
    <tradeName>Monkeypox virus Antigen Test Kit</tradeName>
    <deviceName>Monkeypox virus Antigen Test Kit</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2211525</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:53:32.267Z</lastUpdated>
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    <udiDi>06974854620827</udiDi>
    <basicUdiDi>B-06974854620827</basicUdiDi>
    <tradeName>JWF</tradeName>
    <deviceName>Orthopox virus and Monkeypox virus Antigen Test Kit</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2203525</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:53:28.259Z</lastUpdated>
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    <udiDi>06974854620803</udiDi>
    <basicUdiDi>B-06974854620803</basicUdiDi>
    <tradeName>Flu A/B &amp; COVID-19 Ag Combo Test Kit</tradeName>
    <deviceName>Flu A/B &amp; COVID-19 Ag Combo Test Kit</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2203120</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:53:26.665Z</lastUpdated>
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  <row>
    <udiDi>06974849368611</udiDi>
    <basicUdiDi>B-06974849368611</basicUdiDi>
    <tradeName>Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)</tradeName>
    <deviceName>Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT147C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:52:24.173Z</lastUpdated>
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  <row>
    <udiDi>06974849368604</udiDi>
    <basicUdiDi>B-06974849368604</basicUdiDi>
    <tradeName>Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)</tradeName>
    <deviceName>Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT145B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:52:22.565Z</lastUpdated>
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    <udiDi>06974849368598</udiDi>
    <basicUdiDi>B-06974849368598</basicUdiDi>
    <tradeName>Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)</tradeName>
    <deviceName>Monkeypox Virus IgM/IgG Antibody Detection Kit (Immunochromatography)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT145A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:52:20.170Z</lastUpdated>
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    <udiDi>06974849368581</udiDi>
    <basicUdiDi>B-06974849368581</basicUdiDi>
    <tradeName>Monkeypox Virus Antigen Detection Kit (Immunochromatography)</tradeName>
    <deviceName>Monkeypox Virus Antigen Detection Kit (Immunochromatography)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT079G</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:52:18.567Z</lastUpdated>
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    <udiDi>06974849368567</udiDi>
    <basicUdiDi>B-06974849368567</basicUdiDi>
    <tradeName>Monkeypox Virus Antigen Detection Kit (Immunochromatography)</tradeName>
    <deviceName>Monkeypox Virus Antigen Detection Kit (Immunochromatography)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT079E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:52:17.764Z</lastUpdated>
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    <udiDi>06974785750471</udiDi>
    <basicUdiDi>B-06974785750471</basicUdiDi>
    <tradeName>Rotavirus/Adenovirus Combo Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Rotavirus/Adenovirus Combo Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>Anhui Formaster Biosci Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002305</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRA-3023</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:43:19.253Z</lastUpdated>
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    <udiDi>06974674894026</udiDi>
    <basicUdiDi>B-06974674894026</basicUdiDi>
    <tradeName>Monkeypox Virus Antigen Rapid Test(Lateral Flow Method)</tradeName>
    <deviceName>Monkeypox Virus Antigen Rapid Test(Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:19:20.075Z</lastUpdated>
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    <udiDi>06974674894002</udiDi>
    <basicUdiDi>B-06974674894002</basicUdiDi>
    <tradeName>SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)</tradeName>
    <deviceName>SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>NIC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000033515</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:19:16.054Z</lastUpdated>
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