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    <tradeName>iFlash-EB NA IgG</tradeName>
    <deviceName>iFlash-EB NA IgG</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>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040106</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88008G-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:24.276Z</lastUpdated>
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    <udiDi>03573026064600</udiDi>
    <basicUdiDi>357302BUDI000079TH</basicUdiDi>
    <tradeName>VIDAS® EBV EBNA IgG</tradeName>
    <deviceName>VIDAS® EBV EBNA IgG</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30235</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:48:22.651Z</lastUpdated>
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    <udiDi>D-IENG-402DT</udiDi>
    <basicUdiDi>B-IENG-402DT</basicUdiDi>
    <tradeName>EBNA IgG Rapid Test Cassette</tradeName>
    <deviceName>EBNA IgG 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>
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    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IENG-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:05:32.409Z</lastUpdated>
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    <udiDi>06975577176226</udiDi>
    <basicUdiDi>B-06975577176226</basicUdiDi>
    <tradeName>NA IgG CLIA Microparticles</tradeName>
    <deviceName>NA IgG 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>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0205</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:18:52.339Z</lastUpdated>
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    <udiDi>06975577176196</udiDi>
    <basicUdiDi>B-06975577176196</basicUdiDi>
    <tradeName>NA IgG CLIA Microparticles</tradeName>
    <deviceName>NA IgG 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>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0202</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:18:51.532Z</lastUpdated>
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    <udiDi>+ENTIRE587410J</udiDi>
    <basicUdiDi>B-+ENTIRE587410J</basicUdiDi>
    <tradeName>+ENTIRE587410J</tradeName>
    <deviceName>Epstein-Barr Virus (EBNA) IgG</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>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE58741</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:19:14.141Z</lastUpdated>
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    <udiDi>+ENTIEBVG0580DS0-</udiDi>
    <basicUdiDi>B-+ENTIEBVG0580DS0-</basicUdiDi>
    <tradeName>+ENTIEBVG0580DS0-</tradeName>
    <deviceName>NovaLisa® Epstein-Barr Virus (EBNA) IgG</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>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBVG0580DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:37.175Z</lastUpdated>
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    <udiDi>+ENTIEBVG05800_</udiDi>
    <basicUdiDi>B-+ENTIEBVG05800_</basicUdiDi>
    <tradeName>+ENTIEBVG05800_</tradeName>
    <deviceName>NovaLisa® Epstein-Barr Virus (EBNA) IgG</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>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBVG0580</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:36.374Z</lastUpdated>
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    <udiDi>08056771100687</udiDi>
    <basicUdiDi>80567713105203V</basicUdiDi>
    <tradeName>LIAISON® EBNA IgG</tradeName>
    <deviceName>LIAISON® EBNA IgG</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310520</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:07:55.704Z</lastUpdated>
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    <udiDi>00630414999838</udiDi>
    <basicUdiDi>0405686900224UT</basicUdiDi>
    <tradeName>IMMULITE 2000 EBV-EBNA IgG</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_EBV-EBNA IgG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381307</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:06:40.272Z</lastUpdated>
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    <udiDi>D-IENG-R4027C</udiDi>
    <basicUdiDi>B-IENG-R4027C</basicUdiDi>
    <tradeName>EBNA IgG Rapid Test Cassette</tradeName>
    <deviceName>EBNA IgG 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>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IENG-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:13.980Z</lastUpdated>
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    <udiDi>38594036041104</udiDi>
    <basicUdiDi>B-38594036041104</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-EBNA-1 EBV IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-110-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:53:34.864Z</lastUpdated>
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    <udiDi>28594036044122</udiDi>
    <basicUdiDi>B-28594036044122</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-EBNA-1 EBV IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-412</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:21:56.852Z</lastUpdated>
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    <udiDi>28594036040018</udiDi>
    <basicUdiDi>B-28594036040018</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-EBNA-1 EBV IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-001</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:20:28.667Z</lastUpdated>
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    <udiDi>06925912719151</udiDi>
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    <tradeName>iFlash-EB NA 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>
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    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88008G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:12.975Z</lastUpdated>
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    <tradeName>iFlash-EB NA IgG</tradeName>
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    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
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    <reference>C88008G-S</reference>
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    <lastUpdated>2026-07-11T10:38:13.696Z</lastUpdated>
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    <basicUdiDi>B-18594036041100</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-EBNA-1 EBV IgG</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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    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-110-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:24:48.894Z</lastUpdated>
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    <tradeName>ELISA-VIDITEST anti-EBNA-1 EBV IgG</tradeName>
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    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
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    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-412</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:45:32.648Z</lastUpdated>
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    <tradeName>ELISA-VIDITEST anti-EBNA-1 EBV IgG</tradeName>
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    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-277</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:43:58.775Z</lastUpdated>
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    <tradeName>ELISA-VIDITEST anti-EBNA-1 EBV IgG</tradeName>
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    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-062</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:42:38.455Z</lastUpdated>
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