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    <deviceName>Chlamydia Trachomatis Antigen Test Cassette</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <tradeName>Chlamydia Trachomatis Antigen Test Cassette</tradeName>
    <deviceName>Chlamydia Trachomatis Antigen Test Cassette</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
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    <tradeName>Chlamydia Trachomatis Antigen Test Cassette</tradeName>
    <deviceName>Chlamydia Trachomatis Antigen Test Cassette</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
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    <tradeName>Chlamydia Trachomatis Antigen Test Cassette</tradeName>
    <deviceName>Chlamydia Trachomatis Antigen Test Cassette</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <basicUdiDi>B-06974566302226</basicUdiDi>
    <tradeName>Chlamydia Trachomatis Antigen Test Cassette</tradeName>
    <deviceName>Chlamydia Trachomatis Antigen Test Cassette</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <tradeName>Chlamydia Trachomatis Antigen Test Cassette</tradeName>
    <deviceName>Chlamydia Trachomatis Antigen Test Cassette</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnDescription>CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION</emdnDescription>
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    <deviceName>Human Papillomavirus (HPV) Genotyping Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
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    <deviceName>Human Papillomavirus (HPV) Genotyping Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
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    <lastUpdated>2026-07-06T16:51:02.256Z</lastUpdated>
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    <deviceName>SARS-CoV-2/Flu A/Flu B/RSV/ADV/MP Antigen Rapid Test Kit</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2114-11</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:51:01.446Z</lastUpdated>
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    <deviceName>SARS-CoV-2/Flu A/Flu B/RSV/ADV/MP Antigen Rapid Test Kit</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <deviceName>SARS-CoV-2/Flu A/Flu B/RSV/ADV/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
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    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2508</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:57.443Z</lastUpdated>
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    <deviceName>SARS-CoV-2/Flu A/Flu B/RSV/ADV/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
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    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T16:50:55.835Z</lastUpdated>
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    <deviceName>SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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    <deviceName>SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
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    <lastUpdated>2026-07-06T16:50:53.439Z</lastUpdated>
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    <deviceName>SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
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    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T16:50:51.030Z</lastUpdated>
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    <deviceName>SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>Saliva Pregnancy Test Kit</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2235</reference>
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    <deviceName>Saliva Pregnancy Test Kit</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2235</reference>
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    <deviceName>Urinary Tract Infection (UTI) &amp;DR Panel (Fluorescence PCR method)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
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    <deviceName>Luteinising Hormone (LH) Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
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    <reference>ICA2230</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:28.548Z</lastUpdated>
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