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    <tradeName>iFlash-EB VCA IgA</tradeName>
    <deviceName>iFlash-EB VCA IgA</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>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88011A-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:23.471Z</lastUpdated>
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    <udiDi>06925912715740</udiDi>
    <basicUdiDi>692591270086HM</basicUdiDi>
    <tradeName>iFlash-EB NA IgA</tradeName>
    <deviceName>iFlash-EB NA IgA</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <lastUpdated>2026-07-31T15:30:22.680Z</lastUpdated>
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    <udiDi>D-IECNG-4255F</udiDi>
    <basicUdiDi>B-IECNG-4255F</basicUdiDi>
    <tradeName>EBV VCA and EBNA IgG Combo Rapid Test Cassette</tradeName>
    <deviceName>EBV VCA and EBNA IgG Combo Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <lastUpdated>2026-07-27T22:05:28.410Z</lastUpdated>
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    <udiDi>D-IECA-4027A</udiDi>
    <basicUdiDi>B-IECA-4027A</basicUdiDi>
    <tradeName>EBV VCA IgA Rapid Test Cassette</tradeName>
    <deviceName>EBV VCA IgA Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IECA-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:52.703Z</lastUpdated>
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    <udiDi>06975577176349</udiDi>
    <basicUdiDi>B-06975577176349</basicUdiDi>
    <tradeName>VCA IgA CLIA Microparticles</tradeName>
    <deviceName>VCA IgA CLIA Microparticles</deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0505</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:18:57.141Z</lastUpdated>
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    <udiDi>06975577176318</udiDi>
    <basicUdiDi>B-06975577176318</basicUdiDi>
    <tradeName>VCA IgA CLIA Microparticles</tradeName>
    <deviceName>VCA IgA CLIA Microparticles</deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0502</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:18:56.352Z</lastUpdated>
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    <udiDi>06975577176103</udiDi>
    <basicUdiDi>B-06975577176103</basicUdiDi>
    <tradeName>NA IgA CLIA Microparticles</tradeName>
    <deviceName>NA IgA CLIA MIcroparticles</deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:18:50.746Z</lastUpdated>
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    <udiDi>06975577176073</udiDi>
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    <tradeName>NA IgA CLIA Microparticles</tradeName>
    <deviceName>NA IgA CLIA Microparticles</deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:18:49.951Z</lastUpdated>
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    <udiDi>06975577175861</udiDi>
    <basicUdiDi>B-06975577175861</basicUdiDi>
    <tradeName>EA IgA CLIA Microparticles</tradeName>
    <deviceName>EA IgA CLIA MIcroparticles</deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0405</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:18:44.334Z</lastUpdated>
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    <udiDi>06975577175830</udiDi>
    <basicUdiDi>B-06975577175830</basicUdiDi>
    <tradeName>EA IgA CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:18:43.551Z</lastUpdated>
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    <udiDi>+ENTIEBVA01500P</udiDi>
    <basicUdiDi>B-+ENTIEBVA01500P</basicUdiDi>
    <tradeName>+ENTIEBVA01500P</tradeName>
    <deviceName>NovaLisa® Epstein-Barr Virus (VCA) IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBVA0150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:31.573Z</lastUpdated>
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    <udiDi>+ENTI301136240G</udiDi>
    <basicUdiDi>B-+ENTI301136240G</basicUdiDi>
    <tradeName>+ENTI301136240G</tradeName>
    <deviceName>Epstein-Barr Virus (VCA) IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113624</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:56.712Z</lastUpdated>
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    <udiDi>D-KR-EBV-02100CUL</udiDi>
    <basicUdiDi>B-KR-EBV-02100CUL</basicUdiDi>
    <tradeName>INNODX EBV VCA IgA CMIA</tradeName>
    <deviceName>INNODX EBV VCA IgA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-EBV-02100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:42:47.224Z</lastUpdated>
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    <udiDi>D-KR-EBV-01100CU9</udiDi>
    <basicUdiDi>B-KR-EBV-01100CU9</basicUdiDi>
    <tradeName>INNODX EBV EBNA1 IgA CMIA</tradeName>
    <deviceName>INNODX EBV EBNA1 IgA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-EBV-01100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:42:46.417Z</lastUpdated>
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    <udiDi>D-IECNG-R4255A</udiDi>
    <basicUdiDi>B-IECNG-R4255A</basicUdiDi>
    <tradeName>EBV VCA and EBNA IgG Combo Rapid Test Cassette</tradeName>
    <deviceName>EBV VCA and EBNA IgG Combo 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>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IECNG-R425</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:05:34.626Z</lastUpdated>
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    <udiDi>38594036041111</udiDi>
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    <tradeName>MONO-VIDITEST anti-EBNA-1 EBV IgM</tradeName>
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    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-111-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:53:35.665Z</lastUpdated>
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    <tradeName>MONO-VIDITEST anti-VCA EBV IgA</tradeName>
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    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <reference>ODZ-096</reference>
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    <lastUpdated>2026-07-11T13:20:58.326Z</lastUpdated>
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    <tradeName>ELISA-VIDITEST anti-EBNA-1 EBV IgM</tradeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-002</reference>
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    <lastUpdated>2026-07-11T13:20:47.124Z</lastUpdated>
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