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    <tradeName>SARS-CoV-2 IgG Antibody Detection Kit (Colloidal gold method)</tradeName>
    <deviceName>SARS-CoV-2 IgG Antibody Detection Kit (Colloidal gold method)</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT094A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:51:24.863Z</lastUpdated>
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    <basicUdiDi>B-06974849366242</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method)</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method)</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>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T17:51:18.452Z</lastUpdated>
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    <basicUdiDi>B-06974849366235</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method)</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method)</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>
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    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:51:17.648Z</lastUpdated>
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    <udiDi>06974849366129</udiDi>
    <basicUdiDi>B-06974849366129</basicUdiDi>
    <tradeName>SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)</tradeName>
    <deviceName>SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT062H</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:51:00.828Z</lastUpdated>
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    <udiDi>06974849366112</udiDi>
    <basicUdiDi>B-06974849366112</basicUdiDi>
    <tradeName>SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)</tradeName>
    <deviceName>SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT062H</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:51:00.032Z</lastUpdated>
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    <udiDi>06974849366105</udiDi>
    <basicUdiDi>B-06974849366105</basicUdiDi>
    <tradeName>SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)</tradeName>
    <deviceName>SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)</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>
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    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT062D</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:50:59.237Z</lastUpdated>
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    <basicUdiDi>B-06974849366099</basicUdiDi>
    <tradeName>SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)</tradeName>
    <deviceName>SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)</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>
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    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT062B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:50:58.433Z</lastUpdated>
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    <udiDi>06974849366082</udiDi>
    <basicUdiDi>B-06974849366082</basicUdiDi>
    <tradeName>SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)</tradeName>
    <deviceName>SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT062A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:50:53.634Z</lastUpdated>
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    <udiDi>06974849366075</udiDi>
    <basicUdiDi>B-06974849366075</basicUdiDi>
    <tradeName>SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)</tradeName>
    <deviceName>SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT062C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:50:52.827Z</lastUpdated>
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    <udiDi>06974831192323</udiDi>
    <basicUdiDi>B-06974831192323</basicUdiDi>
    <tradeName>06974831192323</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Huian Biosci Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028080</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST-025</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:48:10.879Z</lastUpdated>
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    <udiDi>06974831192316</udiDi>
    <basicUdiDi>B-06974831192316</basicUdiDi>
    <tradeName>06974831192316</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Huian Biosci Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028080</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST-020</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:48:08.480Z</lastUpdated>
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    <basicUdiDi>B-06974831192309</basicUdiDi>
    <tradeName>06974831192309</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Huian Biosci Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028080</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST-007</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:48:06.871Z</lastUpdated>
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    <udiDi>06974831192293</udiDi>
    <basicUdiDi>B-06974831192293</basicUdiDi>
    <tradeName>06974831192293</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Huian Biosci Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028080</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST-005</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:48:06.065Z</lastUpdated>
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    <udiDi>06974831192286</udiDi>
    <basicUdiDi>B-06974831192286</basicUdiDi>
    <tradeName>06974831192286</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Huian Biosci Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028080</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST-002</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:48:04.469Z</lastUpdated>
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    <basicUdiDi>B-06974831192279</basicUdiDi>
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    <deviceName>SARS-CoV-2 Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Huian Biosci Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028080</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST-001</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:48:02.065Z</lastUpdated>
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    <udiDi>06974785750334</udiDi>
    <basicUdiDi>B-06974785750334</basicUdiDi>
    <tradeName>RSV Rapid Test</tradeName>
    <deviceName>RSV Rapid Test</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>W0105099002</emdnCode>
    <emdnDescription>RSV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRS-1013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:42:54.444Z</lastUpdated>
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    <udiDi>06974689626513</udiDi>
    <basicUdiDi>B-06974689626513</basicUdiDi>
    <tradeName>Monkeypox virus nucleic acid real-time PCR detection kit</tradeName>
    <deviceName>Monkeypox virus nucleic acid real-time PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MV01-2Y32; MV01-1Y32; MV02-Y32;</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:31.797Z</lastUpdated>
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    <basicUdiDi>B-06974677693626</basicUdiDi>
    <tradeName>Nipah virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Nipah Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-FZ-072-50</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:59.647Z</lastUpdated>
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    <basicUdiDi>B-06974677693039</basicUdiDi>
    <tradeName>Enterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing)</tradeName>
    <deviceName>Enterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-FZ-032-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:58.061Z</lastUpdated>
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    <basicUdiDi>B-06974677693022</basicUdiDi>
    <tradeName>Enterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing)</tradeName>
    <deviceName>Enterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-FZ-032-50</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:22:57.254Z</lastUpdated>
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