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<eudamedExport entity="devices">
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    <tradeName>Trichomonas Vaginalis Rapid Test Cassette</tradeName>
    <deviceName>Trichomonas Vaginalis Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITV-R502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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    <udiDi>D-EIM4411116FN</udiDi>
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    <tradeName>D-EIM4411116FN</tradeName>
    <deviceName>Chemiluminescent Immunoassay Assay Kits for TOXO IgG</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
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    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4411116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>D-697994388Fa016WG7V</tradeName>
    <deviceName>Plasmodium Nucleic Acid Detection Kit (Fluorescence)</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050309</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fa016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:19:26.430Z</lastUpdated>
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    <udiDi>69743840312782</udiDi>
    <basicUdiDi>B-69743840312782</basicUdiDi>
    <tradeName>Candida Albicans/Gardnerella Vaginalis /Trichomonas Vaginalis Combo Rapid Test（Swab）</tradeName>
    <deviceName>Cryptosporidium Antigen Rapid Test（Fecal swab）</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050207</emdnCode>
    <emdnDescription>CRYPTOSPORIDIUM</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3025601</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:13:21.285Z</lastUpdated>
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    <udiDi>69743840310702</udiDi>
    <basicUdiDi>B-69743840310702</basicUdiDi>
    <tradeName>Giardia antigen Rapid Test</tradeName>
    <deviceName>Giardia antigen Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050208</emdnCode>
    <emdnDescription>GIARDIA LAMBLIA</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3023701</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:28.640Z</lastUpdated>
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    <udiDi>69743840310320</udiDi>
    <basicUdiDi>B-69743840310320</basicUdiDi>
    <tradeName>Leishmania IgG IgM Rapid Test</tradeName>
    <deviceName>Leishmania IgG IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3023301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:23.541Z</lastUpdated>
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    <basicUdiDi>B-69743840304626</basicUdiDi>
    <tradeName>Toxo IgG/IgM Rapid Test</tradeName>
    <deviceName>Toxo IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050199</emdnCode>
    <emdnDescription>TOXOPLASMA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3022601</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:06.161Z</lastUpdated>
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    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® TV</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050310</emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXTV-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:14.975Z</lastUpdated>
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    <udiDi>+ENTITOXM0460DS0Q</udiDi>
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    <tradeName>+ENTITOXM0460DS0Q</tradeName>
    <deviceName>NovaLisa® Toxoplasma gondii IgM μ-capture</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOXM0460DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:20:09.461Z</lastUpdated>
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    <udiDi>+ENTITOXM04600S</udiDi>
    <basicUdiDi>B-+ENTITOXM04600S</basicUdiDi>
    <tradeName>+ENTITOXM04600S</tradeName>
    <deviceName>NovaLisa® Toxoplasma gondii IgM μ-capture</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOXM0460</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:20:07.861Z</lastUpdated>
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    <deviceName>NovaLisa® Toxoplasma gondii IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:20:05.448Z</lastUpdated>
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    <deviceName>NovaLisa® Toxoplasma gondii IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Ek II Liste B</riskClass>
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    <lastUpdated>2026-07-16T10:20:03.845Z</lastUpdated>
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    <deviceName>NovaLisa® Toxoplasma gondii IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Ek II Liste B</riskClass>
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    <emdnCode>W0105050199</emdnCode>
    <emdnDescription>TOXOPLASMA REAGENTS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:20:03.727Z</lastUpdated>
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    <tradeName>+ENTITOXA04600G</tradeName>
    <deviceName>NovaLisa® Toxoplasma gondii IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:20:01.445Z</lastUpdated>
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    <udiDi>+ENTISCHM04100.</udiDi>
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    <deviceName>NovaLisa® Schistosoma mansoni IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:19:56.640Z</lastUpdated>
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    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
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    <reference>RE58901</reference>
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    <lastUpdated>2026-07-16T10:19:44.633Z</lastUpdated>
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    <deviceName>Ascaris lumbricoides IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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