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    <tradeName>BIOSYNEX</tradeName>
    <deviceName>Early Pregnancy Test</deviceName>
    <manufacturerName>Chembio Biosynex Diagnostics (Hangzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000039047</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860063</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T13:48:59.552Z</lastUpdated>
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    <tradeName>BIOSYNEX</tradeName>
    <deviceName>Simply Pregnancy Test</deviceName>
    <manufacturerName>Chembio Biosynex Diagnostics (Hangzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000039047</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860061</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T13:48:58.764Z</lastUpdated>
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    <udiDi>06977005880088</udiDi>
    <basicUdiDi>697700588C00002OZK</basicUdiDi>
    <tradeName>BIOSYNEX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chembio Biosynex Diagnostics (Hangzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000039047</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>858931</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T13:48:06.374Z</lastUpdated>
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