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    <basicUdiDi>6976343801609020SK</basicUdiDi>
    <tradeName>06976343800017</tradeName>
    <deviceName>CRP HumaFIA SR</deviceName>
    <manufacturerName>Beijing HumaDX Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029051</manufacturerSrn>
    <authorisedRepresentativeName>Human Gesellschaft für Biochemica und Diagnostica mbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025586</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16090/20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T18:02:41.388Z</lastUpdated>
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    <udiDi>04033145206699</udiDi>
    <basicUdiDi>4987026TD-LFMFYZ</basicUdiDi>
    <tradeName>Loopamp™ Malaria Pf Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Human Gesellschaft für Biochemica und Diagnostica mbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025586</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>978000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:02:43.659Z</lastUpdated>
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    <udiDi>04033145206682</udiDi>
    <basicUdiDi>4987026TD-LFMV24</basicUdiDi>
    <tradeName>Loopamp™ Malaria Pv Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Human Gesellschaft für Biochemica und Diagnostica mbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025586</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>975000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:02:42.865Z</lastUpdated>
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    <udiDi>04033145191407</udiDi>
    <basicUdiDi>4987026TD-LFMPZM</basicUdiDi>
    <tradeName>Loopamp™ Malaria Pan Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Human Gesellschaft für Biochemica und Diagnostica mbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025586</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>974000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:02:38.056Z</lastUpdated>
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    <udiDi>04033145191391</udiDi>
    <basicUdiDi>4987026TD-LFPR25</basicUdiDi>
    <tradeName>Loopamp(TM) PURE DNA Extraction Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Human Gesellschaft für Biochemica und Diagnostica mbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025586</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>970000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:02:37.255Z</lastUpdated>
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    <udiDi>04033145191377</udiDi>
    <basicUdiDi>4987026TD-LFTBZE</basicUdiDi>
    <tradeName>Loopamp™ MTBC Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Human Gesellschaft für Biochemica und Diagnostica mbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025586</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>972000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:02:36.448Z</lastUpdated>
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    <udiDi>04033145206705</udiDi>
    <basicUdiDi>4987026TD-LFMPZM</basicUdiDi>
    <tradeName>Loopamp™ Malaria Pan Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Human Gesellschaft für Biochemica und Diagnostica mbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000025586</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-13T09:57:54.888Z</lastUpdated>
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