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    <tradeName>ENA Screen</tradeName>
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    <tradeName>AESKULISA® ENA-6 Stripes</tradeName>
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    <udiDi>04250289500449</udiDi>
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    <tradeName>AESKULISA® ENA-6S</tradeName>
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    <emdnDescription>ENA SCREENING</emdnDescription>
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    <tradeName>ENA screen</tradeName>
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    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® ENA7 Reagents</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>ENA SCREENING</emdnDescription>
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    <tradeName>QUANTA Flash</tradeName>
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    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
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    <tradeName>ENA Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>ENA Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100102</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL2515301C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:46:14.010Z</lastUpdated>
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    <udiDi>06975424225206</udiDi>
    <basicUdiDi>B-06975424225206</basicUdiDi>
    <tradeName>ENA Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>ENA Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100102</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL2515301</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:26.057Z</lastUpdated>
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    <udiDi>06975070769826</udiDi>
    <basicUdiDi>B-06975070769826</basicUdiDi>
    <tradeName>Sharay ENA Screen IgG (CLIA)</tradeName>
    <deviceName>Sharay ENA Screen IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100102</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000786</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:52:05.618Z</lastUpdated>
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    <udiDi>06975070765385</udiDi>
    <basicUdiDi>B-06975070765385</basicUdiDi>
    <tradeName>Sharay ENA Screen IgG (CLIA)</tradeName>
    <deviceName>Sharay ENA Screen IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100102</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18155001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:40:59.748Z</lastUpdated>
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    <udiDi>06974674892251</udiDi>
    <basicUdiDi>B-06974674892251</basicUdiDi>
    <tradeName>ENA Screen FIA Kit</tradeName>
    <deviceName>ENA Screen 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>W0102100102</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0055</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:13:56.158Z</lastUpdated>
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    <udiDi>04049325004443</udiDi>
    <basicUdiDi>B-04049325004443</basicUdiDi>
    <tradeName>ENA Screen 6 ELISA</tradeName>
    <deviceName>ENA Screen 6 ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100102</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE75411</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:09:56.600Z</lastUpdated>
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    <udiDi>03532672001339</udiDi>
    <basicUdiDi>B-03532672001339</basicUdiDi>
    <tradeName>ENA-LISA</tradeName>
    <deviceName>ENA-LISA</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000042615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0102100102</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HM 008</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:42:14.253Z</lastUpdated>
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    <tradeName>Evo Autoimmune SPA</tradeName>
    <deviceName>Autoimmunity SPA ENA Screen - Autoimmunità SPA ENA Screen</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
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    <reference>3AX3020 ENA</reference>
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    <tradeName>CHORUS ENA-6 S</tradeName>
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