<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-0320517401WG</udiDi>
    <basicUdiDi>B-0320517401WG</basicUdiDi>
    <tradeName>EBV IgM (eCLIA)</tradeName>
    <deviceName>EBV IgM (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040103</emdnCode>
    <emdnDescription>EBV IGM - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:33:33.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517304WH</udiDi>
    <basicUdiDi>B-0320517304WH</basicUdiDi>
    <tradeName>EBV EBNA IgG (eCLIA)</tradeName>
    <deviceName>EBV EBNA IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517304</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:33:29.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517303WF</udiDi>
    <basicUdiDi>B-0320517303WF</basicUdiDi>
    <tradeName>EBV EBNA IgG (eCLIA)</tradeName>
    <deviceName>EBV EBNA IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517303</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:33:29.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517302WD</udiDi>
    <basicUdiDi>B-0320517302WD</basicUdiDi>
    <tradeName>EBV EBNA IgG (eCLIA)</tradeName>
    <deviceName>EBV EBNA IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517302</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:33:28.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517301WB</udiDi>
    <basicUdiDi>B-0320517301WB</basicUdiDi>
    <tradeName>EBV EBNA IgG (eCLIA)</tradeName>
    <deviceName>EBV EBNA IgG (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:33:27.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912715726</udiDi>
    <basicUdiDi>692591270084HH</basicUdiDi>
    <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-L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:34:39.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161958451</udiDi>
    <basicUdiDi>859569630001Q3</basicUdiDi>
    <tradeName>GeneProof Epstein-Barr Virus (EBV) PCR Kit</tradeName>
    <deviceName>GeneProof Epstein-Barr Virus (EBV) PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</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>EBV/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:18.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161958437</udiDi>
    <basicUdiDi>859569630001Q3</basicUdiDi>
    <tradeName>GeneProof Epstein-Barr Virus (EBV) PCR Kit</tradeName>
    <deviceName>GeneProof Epstein-Barr Virus (EBV) PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</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>EBV/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:17.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891328986</udiDi>
    <basicUdiDi>803389132CHORUSEAG0044</basicUdiDi>
    <tradeName>CHORUS EPSTEIN-BARR EARLY ANTIGEN IgG</tradeName>
    <deviceName>CHORUS EPSTEIN-BARR EARLY ANTIGEN IgG</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040108</emdnCode>
    <emdnDescription>EBV EA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81058/12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:43:45.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891322373</udiDi>
    <basicUdiDi>803389132CHORUSEAG0044</basicUdiDi>
    <tradeName>CHORUS EPSTEIN-BARR EARLY ANTIGEN IgG</tradeName>
    <deviceName>CHORUS EPSTEIN-BARR EARLY ANTIGEN IgG</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010504040108</emdnCode>
    <emdnDescription>EBV EA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81058</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:43:07.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731820</udiDi>
    <basicUdiDi>B-06955792731820</basicUdiDi>
    <tradeName>06955792731820</tradeName>
    <deviceName>Epstein-Barr Virus(EBV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3349E-12-P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:14.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730991</udiDi>
    <basicUdiDi>B-06955792730991</basicUdiDi>
    <tradeName>06955792730991</tradeName>
    <deviceName>Epstein-Barr virus DNA Quantitative Fluorescence Diagnostic Kit(PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3015E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:29:35.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792701663</udiDi>
    <basicUdiDi>69557927S3213E000001PC</basicUdiDi>
    <tradeName>06955792701663</tradeName>
    <deviceName>Epstein-Barr virus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3213E-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:21:22.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339205131</udiDi>
    <basicUdiDi>B-06937339205131</basicUdiDi>
    <tradeName>VivaDiag Epstein-Barr Virus Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID132-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:51.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884999050839</udiDi>
    <basicUdiDi>0884999AMN0027WG</basicUdiDi>
    <tradeName>Alinity m</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009457</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N43-092</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:48:41.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884999049635</udiDi>
    <basicUdiDi>0884999AMN0016WB</basicUdiDi>
    <tradeName>Alinity m</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009457</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N43-080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:48:41.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884999050822</udiDi>
    <basicUdiDi>0884999AMN0027WG</basicUdiDi>
    <tradeName>Alinity m</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009457</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N43-082</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:48:41.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658555802</udiDi>
    <basicUdiDi>B-04260658555802</basicUdiDi>
    <tradeName>Atlas IM Latex , 100 Tests</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040499</emdnCode>
    <emdnDescription>EBV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.08.0.0100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:35:49.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658551187</udiDi>
    <basicUdiDi>B-04260658551187</basicUdiDi>
    <tradeName>Atlas IM Latex Kit, 50 Tests (2ml Reagent, 2x0.5mlControls)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040499</emdnCode>
    <emdnDescription>EBV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.31.0.0050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:12.845Z</lastUpdated>
  </row>
</eudamedExport>