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    <deviceName>abTES™ Malaria qPCR I Kit (50 Reactions)</deviceName>
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    <tradeName>Detection Kit for Plasmodium Falciparum (PCR Fluorescence Probing)</tradeName>
    <deviceName>Detection Kit for Plasmodium Falciparum (PCR Fluorescence Probing)</deviceName>
    <manufacturerName>SINGUWAY BIOTECH INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000027180</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <emdnDescription>PLASMODIUM (MALARIA) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF001-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:51:05.885Z</lastUpdated>
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    <tradeName>BIOSYNEX AMPLIFLASH MALARIA</tradeName>
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    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050309</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150053</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:27:01.117Z</lastUpdated>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>BIOSYNEX AMPLIQUICK Malaria</tradeName>
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    <emdnDescription>PLASMODIUM (MALARIA) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>BIOSYNEX AMPLIFLASH MALARIA</tradeName>
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    <emdnDescription>PLASMODIUM (MALARIA) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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