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    <tradeName>Aptima Trichomonas vaginalis Assay</tradeName>
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    <manufacturerName>Hologic</manufacturerName>
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    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
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    <tradeName>Aptima Trichomonas vaginalis Assay</tradeName>
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    <tradeName>Aptima Trichomonas vaginalis Controls Kit</tradeName>
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    <manufacturerName>Hologic</manufacturerName>
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    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
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    <tradeName>TRUPCR® Toxoplasma Real-Time PCR Detection Kit</tradeName>
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    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>TOXOPLASMA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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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>
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    <lastUpdated>2026-06-29T08:20:06.598Z</lastUpdated>
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    <udiDi>03661540101021</udiDi>
    <basicUdiDi>3661540PARhemag027E</basicUdiDi>
    <tradeName>HYDATIDOSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ELITECH MICROBIO</manufacturerName>
    <manufacturerSrn>FR-MF-000025235</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050204</emdnCode>
    <emdnDescription>ECHINOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5248</reference>
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    <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>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050101</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY (TOTAL)</emdnDescription>
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    <tradeName>BIOSYNEX AMPLIQUICK Malaria</tradeName>
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    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050309</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>3120019_SEC02</reference>
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    <tradeName>BIOSYNEX AMPLIFLASH MALARIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050309</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150053L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:40:30.912Z</lastUpdated>
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    <basicUdiDi>B-06947145505455</basicUdiDi>
    <tradeName>MAGLUMI Chagas (CLIA)</tradeName>
    <deviceName>Chagas (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130219001M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:55.404Z</lastUpdated>
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    <udiDi>06942293581856</udiDi>
    <basicUdiDi>697518250E118072H</basicUdiDi>
    <tradeName>PV and HB Combo Rapid Test Kit</tradeName>
    <deviceName>PV and HB Combo Rapid Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E11807</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:27:00.424Z</lastUpdated>
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    <udiDi>06942293581788</udiDi>
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    <tradeName>06942293581788</tradeName>
    <deviceName>Malaria P.f Antibody Rapid Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G11832</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:26:49.725Z</lastUpdated>
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    <udiDi>06942293581771</udiDi>
    <basicUdiDi>697518250G1183138</basicUdiDi>
    <tradeName>Malaria P.f Antigen Rapid Test Kit</tradeName>
    <deviceName>Malaria P.f Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G11831</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:26:48.417Z</lastUpdated>
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    <udiDi>06942293580972</udiDi>
    <basicUdiDi>697518250G118173E</basicUdiDi>
    <tradeName>Malaria P.f/Pan Antigen Combo Rapid Test Kit</tradeName>
    <deviceName>Malaria P.f/Pan Antigen Combo Rapid Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G11817</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:24:35.268Z</lastUpdated>
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    <tradeName>Malaria P.f/P.v Antigen Combo Rapid Test Kit</tradeName>
    <deviceName>Malaria P.f/P.v Antigen Combo Rapid Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G11805</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:21:58.251Z</lastUpdated>
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    <udiDi>06925912717133</udiDi>
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    <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>
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    <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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    <tradeName>Malaria P.f/Pan Antigen Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0102201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:32.883Z</lastUpdated>
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    <tradeName>Malaria P.f/P.v Antigen Rapid Test</tradeName>
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    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
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    <reference>BT0102101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:31.471Z</lastUpdated>
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    <tradeName>Malaria P.v Antigen Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0102001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:29.062Z</lastUpdated>
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    <tradeName>Malaria P.f Antigen Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0101901</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:27.858Z</lastUpdated>
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