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<eudamedExport entity="devices">
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    <udiDi>08908015304996</udiDi>
    <basicUdiDi>89080153043B279P2</basicUdiDi>
    <tradeName>TRUPCR® Toxoplasma Real-Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050105</emdnCode>
    <emdnDescription>TOXOPLASMA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B279</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:06.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>03661540101045</udiDi>
    <basicUdiDi>3661540PARhemag017C</basicUdiDi>
    <tradeName>TOXO HAI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ELITECH MICROBIO</manufacturerName>
    <manufacturerSrn>FR-MF-000025235</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050101</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T04:23:06.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912717133</udiDi>
    <basicUdiDi>692591270101GQ</basicUdiDi>
    <tradeName>iFlash-Toxo IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050104</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG - AVIDITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88029G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:12:59.424Z</lastUpdated>
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  <row>
    <udiDi>06438172116016</udiDi>
    <basicUdiDi>B-06438172116016</basicUdiDi>
    <tradeName>Neonatal Toxoplasma gondii IgM FEIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6199802</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:40:00.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189216096</udiDi>
    <basicUdiDi>45601892100010737K</basicUdiDi>
    <tradeName>CL AIA-PACK Toxo IgM ADJUSTER SET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029262</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T17:04:07.566Z</lastUpdated>
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