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<eudamedExport entity="devices">
  <row>
    <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>
  </row>
  <row>
    <udiDi>D-IECG-4029C</udiDi>
    <basicUdiDi>B-IECG-4029C</basicUdiDi>
    <tradeName>EBV VCA IgG Rapid Test Cassette</tradeName>
    <deviceName>EBV VCA 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>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IECG-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:53.503Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>10743816000921</udiDi>
    <basicUdiDi>B-10743816000921</basicUdiDi>
    <tradeName>BioSign Mono</tradeName>
    <deviceName>BioSign Mono</deviceName>
    <manufacturerName>Princeton BioMeditech Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000048310</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BSP-402WB-35</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T08:49:19.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577176585</udiDi>
    <basicUdiDi>B-06975577176585</basicUdiDi>
    <tradeName>VCA IgG CLIA Microparticles</tradeName>
    <deviceName>VCA 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>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0705</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:19:03.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577176554</udiDi>
    <basicUdiDi>B-06975577176554</basicUdiDi>
    <tradeName>VCA IgG CLIA Microparticles</tradeName>
    <deviceName>VCA 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>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0702</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:19:02.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577176462</udiDi>
    <basicUdiDi>B-06975577176462</basicUdiDi>
    <tradeName>VCA IgM CLIA Microparticles</tradeName>
    <deviceName>VCA IgM 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>W010504040104</emdnCode>
    <emdnDescription>EBV VCA IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0605</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:18:58.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577176431</udiDi>
    <basicUdiDi>B-06975577176431</basicUdiDi>
    <tradeName>VCA IgM CLIA Microparticles</tradeName>
    <deviceName>VCA IgM 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>W010504040104</emdnCode>
    <emdnDescription>EBV VCA IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0602</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:18:57.951Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0502</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:18:56.352Z</lastUpdated>
  </row>
  <row>
    <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>
    <riskClass>IVD Genel</riskClass>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:18:50.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577176073</udiDi>
    <basicUdiDi>B-06975577176073</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>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <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>
  </row>
  <row>
    <udiDi>06975577175984</udiDi>
    <basicUdiDi>B-06975577175984</basicUdiDi>
    <tradeName>EA IgG CLIA Microparticles</tradeName>
    <deviceName>EA 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>W010504040108</emdnCode>
    <emdnDescription>EBV EA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0305</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:18:45.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975577175953</udiDi>
    <basicUdiDi>B-06975577175953</basicUdiDi>
    <tradeName>EA IgG CLIA Microparticles</tradeName>
    <deviceName>EA 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>W010504040108</emdnCode>
    <emdnDescription>EBV EA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMX0302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-21T23:18:45.144Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>D-697603130A0204EYRS4J</udiDi>
    <basicUdiDi>B-697603130A0204EYRS4J</basicUdiDi>
    <tradeName>D-697603130A0204EYRS4J</tradeName>
    <deviceName>Epstein-Barr virus Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101A0204EY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:24.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960AEBV01P6X4</udiDi>
    <basicUdiDi>B-69509960AEBV01P6X4</basicUdiDi>
    <tradeName>D-69509960AEBV01P6X4</tradeName>
    <deviceName>Epstein-Barr virus Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"AEBV01-AOG48E, AEBV01D-AOG48E"</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:36.893Z</lastUpdated>
  </row>
</eudamedExport>