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    <basicUdiDi>B-06974674893999</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>18-02-0039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:19:14.480Z</lastUpdated>
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    <udiDi>06974674892367</udiDi>
    <basicUdiDi>B-06974674892367</basicUdiDi>
    <tradeName>Adenovirus FIA Kit</tradeName>
    <deviceName>Adenovirus FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0066</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:15.370Z</lastUpdated>
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    <udiDi>06974674890790</udiDi>
    <basicUdiDi>B-06974674890790</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>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>18-02-0014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:10:51.826Z</lastUpdated>
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    <udiDi>06974671100823</udiDi>
    <basicUdiDi>B-06974671100823</basicUdiDi>
    <tradeName>06974671100823</tradeName>
    <deviceName>2019 Novel Coronavirus (2019-nCoV) Antigen Qualitative Diagnostic Kit (CLIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CLIA-nCoV-A002</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:08:03.177Z</lastUpdated>
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    <udiDi>06974566303735</udiDi>
    <basicUdiDi>B-06974566303735</basicUdiDi>
    <tradeName>Adenovirus IgM Rapid Test</tradeName>
    <deviceName>Adenovirus IgM 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>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RAM-602</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:59.242Z</lastUpdated>
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    <udiDi>06974566303582</udiDi>
    <basicUdiDi>B-06974566303582</basicUdiDi>
    <tradeName>Chikungunya Antibody Rapid Test</tradeName>
    <deviceName>Chikungunya Antibody 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>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA-402</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:20.768Z</lastUpdated>
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    <udiDi>06974566303537</udiDi>
    <basicUdiDi>B-06974566303537</basicUdiDi>
    <tradeName>Coxsackievirus A16 IgM Rapid Test</tradeName>
    <deviceName>Coxsackievirus A16 IgM 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>W0105040602</emdnCode>
    <emdnDescription>ENTEROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICV-402</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:12.760Z</lastUpdated>
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    <udiDi>06974566303490</udiDi>
    <basicUdiDi>B-06974566303490</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test</tradeName>
    <deviceName>Dengue IgG/IgM 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>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-422</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:06.365Z</lastUpdated>
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    <udiDi>06974566303483</udiDi>
    <basicUdiDi>B-06974566303483</basicUdiDi>
    <tradeName>Dengue IgG/IgM/NS1 Rapid Test</tradeName>
    <deviceName>Dengue IgG/IgM/NS1 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>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-432</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:05.556Z</lastUpdated>
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    <udiDi>06974566303476</udiDi>
    <basicUdiDi>B-06974566303476</basicUdiDi>
    <tradeName>Dengue NS1 Rapid Test</tradeName>
    <deviceName>Dengue NS1 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>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDE-402</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:01.554Z</lastUpdated>
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    <udiDi>06974566303445</udiDi>
    <basicUdiDi>B-06974566303445</basicUdiDi>
    <tradeName>Enterovirus V71 IgM Rapid Test</tradeName>
    <deviceName>Enterovirus V71 IgM 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>W0105040602</emdnCode>
    <emdnDescription>ENTEROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IEV-402</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:58.346Z</lastUpdated>
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    <udiDi>06974566303407</udiDi>
    <basicUdiDi>B-06974566303407</basicUdiDi>
    <tradeName>Flu A&amp;B/ Covid-19/ RSV/ Adenovirus /MP Antigen Rapid Test Panel</tradeName>
    <deviceName>Flu A&amp;B/ Covid-19/ RSV/ Adenovirus /MP Antigen Rapid Test Panel</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>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRP-852</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:51.962Z</lastUpdated>
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    <udiDi>06974566303322</udiDi>
    <basicUdiDi>B-06974566303322</basicUdiDi>
    <tradeName>HPIVS Rapid Test</tradeName>
    <deviceName>HPIVS 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>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RHP-602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:38.332Z</lastUpdated>
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    <udiDi>06974566303254</udiDi>
    <basicUdiDi>B-06974566303254</basicUdiDi>
    <tradeName>Inﬂuenza A Antigen Rapid Test</tradeName>
    <deviceName>Inﬂuenza A 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>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RINa-8021</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:25.526Z</lastUpdated>
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    <basicUdiDi>B-06974566303247</basicUdiDi>
    <tradeName>Inﬂuenza A Antigen Rapid Test</tradeName>
    <deviceName>Inﬂuenza A 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>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RINa-80220</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:24.719Z</lastUpdated>
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    <basicUdiDi>B-06974566303230</basicUdiDi>
    <tradeName>Inﬂuenza A Antigen Rapid Test</tradeName>
    <deviceName>Inﬂuenza A 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>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RINa-80225</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:20.716Z</lastUpdated>
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    <udiDi>06974566303223</udiDi>
    <basicUdiDi>B-06974566303223</basicUdiDi>
    <tradeName>Inﬂuenza A+B Antigen Rapid Test Device</tradeName>
    <deviceName>Inﬂuenza A+B Antigen Rapid Test Device</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>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RIN-82225</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:20.023Z</lastUpdated>
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    <basicUdiDi>B-06974566303216</basicUdiDi>
    <tradeName>Inﬂuenza A+B Antigen Rapid Test Device</tradeName>
    <deviceName>Inﬂuenza A+B Antigen Rapid Test Device</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>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RIN-82220</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:18.315Z</lastUpdated>
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    <basicUdiDi>B-06974566303209</basicUdiDi>
    <tradeName>Inﬂuenza A+B Antigen Rapid Test Device</tradeName>
    <deviceName>Inﬂuenza A+B Antigen Rapid Test Device</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>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RIN-8221</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:17.516Z</lastUpdated>
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    <udiDi>06974566303193</udiDi>
    <basicUdiDi>B-06974566303193</basicUdiDi>
    <tradeName>Inﬂuenza B Antigen Rapid Test</tradeName>
    <deviceName>Inﬂuenza B 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>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RINb-8021</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:13.517Z</lastUpdated>
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