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    <tradeName>iFlash-EB EA IgG</tradeName>
    <deviceName>iFlash-EB EA 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>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040108</emdnCode>
    <emdnDescription>EBV EA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86141G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:51.946Z</lastUpdated>
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    <tradeName>iFlash-EB EA IgM</tradeName>
    <deviceName>iFlash-EB EA IgM</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>
    <emdnCode>W010504040107</emdnCode>
    <emdnDescription>EBV EA IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88009M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:05.071Z</lastUpdated>
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    <udiDi>06925912715719</udiDi>
    <basicUdiDi>692591270083HF</basicUdiDi>
    <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>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88008G-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:24.276Z</lastUpdated>
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    <udiDi>06925912715733</udiDi>
    <basicUdiDi>692591270085HK</basicUdiDi>
    <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>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88012A-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:22.680Z</lastUpdated>
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    <udiDi>06925912715702</udiDi>
    <basicUdiDi>692591270082HD</basicUdiDi>
    <tradeName>iFlash-EB VCA IgM</tradeName>
    <deviceName>iFlash-EB VCA IgM</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>
    <emdnCode>W010504040104</emdnCode>
    <emdnDescription>EBV VCA IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88007M-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:19.494Z</lastUpdated>
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    <udiDi>06925912715696</udiDi>
    <basicUdiDi>692591270081HB</basicUdiDi>
    <tradeName>iFlash-EB VCA IgG</tradeName>
    <deviceName>iFlash-EB VCA 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>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88006G-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:30:19.353Z</lastUpdated>
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    <udiDi>03573026387648</udiDi>
    <basicUdiDi>357302BUDI000198TS</basicUdiDi>
    <tradeName>EBV R-GENE®</tradeName>
    <deviceName>EBV R-GENE®</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>69-002B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:51:31.723Z</lastUpdated>
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    <udiDi>03573026064617</udiDi>
    <basicUdiDi>357302BUDI000080T2</basicUdiDi>
    <tradeName>VIDAS® EBV VCA/EA IgG</tradeName>
    <deviceName>VIDAS® EBV VCA/EA IgG</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30236</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:48:23.474Z</lastUpdated>
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  <row>
    <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>
    <riskClass>IVD Sınıf B</riskClass>
    <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>03573026064624</udiDi>
    <basicUdiDi>357302BUDI000081T4</basicUdiDi>
    <tradeName>VIDAS® EBV VCA IgM</tradeName>
    <deviceName>VIDAS® EBV VCA IgM</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040104</emdnCode>
    <emdnDescription>EBV VCA IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30237</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:48:21.048Z</lastUpdated>
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    <udiDi>08435440244042</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_EBV64</basicUdiDi>
    <tradeName>VIASURE EBV q Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE EBV q Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-EBV106L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:22:26.387Z</lastUpdated>
  </row>
  <row>
    <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>
    <emdnCode>W010504040106</emdnCode>
    <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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  <row>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IECNG-425</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:05:28.410Z</lastUpdated>
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    <udiDi>08435440244059</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_EBV64</basicUdiDi>
    <tradeName>VIASURE EBV q Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-EBV106H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:58:54.204Z</lastUpdated>
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    <udiDi>08435440244066</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_EBV64</basicUdiDi>
    <tradeName>VIASURE EBV q Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-EBV112L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:58:53.871Z</lastUpdated>
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    <udiDi>08435440244073</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_EBV64</basicUdiDi>
    <tradeName>VIASURE EBV q Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-EBV112H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:58:48.134Z</lastUpdated>
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    <udiDi>08435440244080</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_EBV64</basicUdiDi>
    <tradeName>VIASURE EBV q Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-EBV113L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:58:47.849Z</lastUpdated>
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    <udiDi>08435440244097</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_EBV64</basicUdiDi>
    <tradeName>VIASURE EBV q Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-EBV113H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:58:41.061Z</lastUpdated>
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    <udiDi>08435440257875</udiDi>
    <basicUdiDi>84354402_MDXIMMUN_EBV64</basicUdiDi>
    <tradeName>VIASURE EBV q Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-EBV196T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:58:40.821Z</lastUpdated>
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