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    <deviceName>Fecal Occult Blood/Transferrin Combo Rapid Test</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
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    <deviceName>Fecal Occult Blood/Transferrin Combo Rapid Test</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
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    <tradeName>Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)</tradeName>
    <deviceName>Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <udiDi>06974849366044</udiDi>
    <basicUdiDi>B-06974849366044</basicUdiDi>
    <tradeName>Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)</tradeName>
    <deviceName>Detection Kit for Group A rotavirus and Adenovirus antigens (Colloidal gold)</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>
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    <lastUpdated>2026-07-06T17:50:35.947Z</lastUpdated>
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    <basicUdiDi>B-06974735361849</basicUdiDi>
    <tradeName>KEYU Giardia lamblia Antigen Detection Kit (Colloidal Gold Method)</tradeName>
    <deviceName>Giardia Lamblia Antigen Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL-I</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:36:13.486Z</lastUpdated>
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    <basicUdiDi>B-06974521002260</basicUdiDi>
    <tradeName>25-Hydroxyvitamin D (25-OH-VD) Rapid Quantitative Test Kit (FIA)</tradeName>
    <deviceName>25-Hydroxyvitamin D (25-OH-VD) Rapid Quantitative Test Kit (FIA)</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPF122024</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:32:09.165Z</lastUpdated>
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    <tradeName>D-06973914383078X5</tradeName>
    <deviceName>Novel Coronavirus (2019-nCoV) Antigen Rapid Test</deviceName>
    <manufacturerName>Tianjin Bioscience Diagnostic Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023301</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
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    <lastUpdated>2026-07-06T14:54:24.650Z</lastUpdated>
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    <deviceName>Novel Coronavirus (2019-nCoV) Antigen Rapid Test</deviceName>
    <manufacturerName>Tianjin Bioscience Diagnostic Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023301</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H201.03.00171.001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:47:21.604Z</lastUpdated>
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    <basicUdiDi>B-06973914383092</basicUdiDi>
    <tradeName>06973914383092</tradeName>
    <deviceName>Novel Coronavirus (2019-nCoV) Antigen Rapid Test</deviceName>
    <manufacturerName>Tianjin Bioscience Diagnostic Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023301</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H201.03.00180.001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:47:16.696Z</lastUpdated>
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    <basicUdiDi>B-06973914383085</basicUdiDi>
    <tradeName>06973914383085</tradeName>
    <deviceName>Novel Coronavirus (2019-nCoV) Antigen Rapid Test</deviceName>
    <manufacturerName>Tianjin Bioscience Diagnostic Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023301</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H201.03.00175.001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:47:15.895Z</lastUpdated>
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    <basicUdiDi>B-06973316742541</basicUdiDi>
    <tradeName>06973316742541</tradeName>
    <deviceName>Ferritin Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R331103</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:06:48.584Z</lastUpdated>
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    <tradeName>06973316742534</tradeName>
    <deviceName>Ferritin Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:06:47.779Z</lastUpdated>
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    <tradeName>06973316742527</tradeName>
    <deviceName>Ferritin Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:06:46.985Z</lastUpdated>
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    <tradeName>06973316742510</tradeName>
    <deviceName>Ferritin Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Diasia Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010281</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R331100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:06:42.978Z</lastUpdated>
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    <tradeName>Kit de Prueba de Metalopeptidasa Matricial 9 (MMP-9 POC)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Seinda Biomedical Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000047055</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S05B-020, S05B-050</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:18:08.015Z</lastUpdated>
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    <basicUdiDi>B-06972976463254</basicUdiDi>
    <tradeName>Kit de Prueba de Linfotoxina-α (LTA POC)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Seinda Biomedical Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000047055</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S02B-020, S02B-050</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:18:02.326Z</lastUpdated>
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    <basicUdiDi>B-06972976463193</basicUdiDi>
    <tradeName>MMP9-POC</tradeName>
    <deviceName>Matrix Metallopeptidase 9 Test Kit (MMP-9 POC)</deviceName>
    <manufacturerName>Seinda Biomedical Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000047055</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S05B-020, S05B-050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:18:01.502Z</lastUpdated>
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    <basicUdiDi>B-06972976463032</basicUdiDi>
    <tradeName>LTA-POC</tradeName>
    <deviceName>Lymphotoxin-α Test Kit (LTA POC)</deviceName>
    <manufacturerName>Seinda Biomedical Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000047055</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S02B-020, S02B-050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:17:56.705Z</lastUpdated>
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    <basicUdiDi>B-06971100211365</basicUdiDi>
    <tradeName>06971100211365</tradeName>
    <deviceName>Diagnostic Kit for Calprotectin（Fluorescence  Immunochromatographic Assay）</deviceName>
    <manufacturerName>Xiamen Wiz Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029590</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1C205020001, A1C205020002, A1C205020003, A1C205020004, A1C205020005, A1C205020006, A1C205020007.</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:08:19.448Z</lastUpdated>
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    <tradeName>OnSight™ Cortisol Quantitative Test</tradeName>
    <deviceName>OnSight™ Cortisol Quantitative Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>655-25-DB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:46.032Z</lastUpdated>
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