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    <tradeName>Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RA1FE-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:57.039Z</lastUpdated>
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    <udiDi>06952062710035</udiDi>
    <basicUdiDi>B-06952062710035</basicUdiDi>
    <tradeName>Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RA1FE-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:50.644Z</lastUpdated>
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    <udiDi>06952062710028</udiDi>
    <basicUdiDi>B-06952062710028</basicUdiDi>
    <tradeName>Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RA1FE-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:49.844Z</lastUpdated>
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    <udiDi>06974849366471</udiDi>
    <basicUdiDi>B-06974849366471</basicUdiDi>
    <tradeName>SARS-CoV-2, Influenza A&amp;B Antigen Combined Detection Kit (Immunochromatography)</tradeName>
    <deviceName>SARS-CoV-2, Influenza A&amp;B Antigen Combined 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>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT101B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:52:04.959Z</lastUpdated>
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    <udiDi>06974849366464</udiDi>
    <basicUdiDi>B-06974849366464</basicUdiDi>
    <tradeName>SARS-CoV-2, Influenza A&amp;B Antigen Combined Detection Kit (Immunochromatography)</tradeName>
    <deviceName>SARS-CoV-2, Influenza A&amp;B Antigen Combined 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>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT101A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:52:03.361Z</lastUpdated>
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    <udiDi>06974849366358</udiDi>
    <basicUdiDi>B-06974849366358</basicUdiDi>
    <tradeName>SARS-COV-2 and Influenza A/B Antigen Detection Kit (Immunochromatography)</tradeName>
    <deviceName>SARS-COV-2 and Influenza A/B 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>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT096B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:51:36.877Z</lastUpdated>
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    <udiDi>06974849366341</udiDi>
    <basicUdiDi>B-06974849366341</basicUdiDi>
    <tradeName>SARS-COV-2 and Influenza A/B Antigen Detection Kit (Immunochromatography)</tradeName>
    <deviceName>SARS-COV-2 and Influenza A/B 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>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT096A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:51:32.871Z</lastUpdated>
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    <udiDi>06974849366334</udiDi>
    <basicUdiDi>B-06974849366334</basicUdiDi>
    <tradeName>SARS-COV-2, Influenza A and Influenza B Antigen Detection Kit (Immunochromatography)</tradeName>
    <deviceName>SARS-COV-2, Influenza A and Influenza B 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>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT096B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:51:32.070Z</lastUpdated>
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    <udiDi>06974849366327</udiDi>
    <basicUdiDi>B-06974849366327</basicUdiDi>
    <tradeName>SARS-COV-2, Influenza A and Influenza B Antigen Detection Kit (Immunochromatography)</tradeName>
    <deviceName>SARS-COV-2, Influenza A and Influenza B 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>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT096A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:51:31.273Z</lastUpdated>
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    <udiDi>06974674892558</udiDi>
    <basicUdiDi>B-06974674892558</basicUdiDi>
    <tradeName>Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)</tradeName>
    <deviceName>Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)</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>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01-0015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:27.029Z</lastUpdated>
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    <udiDi>06974674892541</udiDi>
    <basicUdiDi>B-06974674892541</basicUdiDi>
    <tradeName>Influenza A+B virus &amp; 2019-nCoV (2019-nCoV orf1ab/N Gene) Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Influenza A+B virus &amp; 2019-nCoV (2019-nCoV orf1ab/N Gene) Diagnostic Kit (PCR-Fluorescence Probing)</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>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01-0014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:26.226Z</lastUpdated>
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    <udiDi>06974674892534</udiDi>
    <basicUdiDi>B-06974674892534</basicUdiDi>
    <tradeName>Rhinovirus, Respiratory Syncytial Virus &amp; respiratory Adenovirus Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Rhinovirus, Respiratory Syncytial Virus &amp; respiratory Adenovirus Diagnostic Kit (PCR-Fluorescence Probing)</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>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01-0013</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:25.422Z</lastUpdated>
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    <udiDi>06974566303438</udiDi>
    <basicUdiDi>B-06974566303438</basicUdiDi>
    <tradeName>EnterovirusV71+Coxsackievirus A16 Combo Test</tradeName>
    <deviceName>EnterovirusV71+Coxsackievirus A16 Combo Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICE-422</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:54.346Z</lastUpdated>
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    <udiDi>06974566302974</udiDi>
    <basicUdiDi>B-06974566302974</basicUdiDi>
    <tradeName>Rotavirus and Adenovirus Antigen Rapid Test</tradeName>
    <deviceName>Rotavirus and Adenovirus Antigen Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnCode>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RAD-622</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:54:00.938Z</lastUpdated>
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    <udiDi>06974566302950</udiDi>
    <basicUdiDi>B-06974566302950</basicUdiDi>
    <tradeName>Rotavirus Group+Adenovirus+Norovir us G1+Norovirus GII combo  Rapid Test</tradeName>
    <deviceName>Rotavirus Group+Adenovirus+Norovir us G1+Norovirus GII combo  Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RAN-642</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:53:55.334Z</lastUpdated>
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    <udiDi>06974521003281</udiDi>
    <basicUdiDi>B-06974521003281</basicUdiDi>
    <tradeName>Diagnostic Kit for InFluA/InFluB Ag (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Diagnostic Kit for InFluA/InFluB Ag (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPF050025</reference>
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    <lastUpdated>2026-07-06T16:36:14.183Z</lastUpdated>
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    <basicUdiDi>B-06974521001799</basicUdiDi>
    <tradeName>COVID-19 Ag&amp;Influenza A/B Combo Test (Immunochromatography Assay)</tradeName>
    <deviceName>COVID-19 Ag&amp;Influenza A/B Combo Test (Immunochromatography Assay)</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPL028025</reference>
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    <lastUpdated>2026-07-06T16:31:29.044Z</lastUpdated>
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    <basicUdiDi>B-06974521001775</basicUdiDi>
    <tradeName>COVID-19 Ag&amp;Influenza A/B&amp;RSV Ag Combo Test (Immunochromatography Assay)</tradeName>
    <deviceName>COVID-19 Ag&amp;Influenza A/B&amp;RSV Ag Combo Test (Immunochromatography Assay)</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPL029025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:31:24.256Z</lastUpdated>
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    <tradeName>mariPOC® Quick Flu+ test plate</tradeName>
    <deviceName>mariPOC® Quick Flu+ test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1224M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:15.250Z</lastUpdated>
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    <tradeName>mariPOC® Respi test plate</tradeName>
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    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01050799</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1154M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:12.860Z</lastUpdated>
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