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<eudamedExport entity="devices">
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    <udiDi>08885013953497</udiDi>
    <basicUdiDi>B-08885013953497</basicUdiDi>
    <tradeName>Sentosa SA EBV Quantitation Controls (4x2)</tradeName>
    <deviceName>Sentosa SA EBV Quantitation Controls (4x2)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:17:28.890Z</lastUpdated>
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  <row>
    <udiDi>08885013953480</udiDi>
    <basicUdiDi>B-08885013953480</basicUdiDi>
    <tradeName>Sentosa SA EBV Quantitation Standards (2x13)</tradeName>
    <deviceName>Sentosa SA EBV Quantitation Standards (2x13)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300109</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:17:28.879Z</lastUpdated>
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  <row>
    <udiDi>08885013953473</udiDi>
    <basicUdiDi>B-08885013953473</basicUdiDi>
    <tradeName>Sentosa SA EBV PCR Test (4x24)</tradeName>
    <deviceName>Sentosa SA EBV PCR Test (4x24)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:17:21.549Z</lastUpdated>
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    <udiDi>08698898740133</udiDi>
    <basicUdiDi>B-08698898740133</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion EBV QNP 1.0 EBV Real-Time PCR Kit</deviceName>
    <manufacturerName>IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000023054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0360202</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:59:55.636Z</lastUpdated>
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  <row>
    <udiDi>08684998274692</udiDi>
    <basicUdiDi>B-08684998274692</basicUdiDi>
    <tradeName>LyoSens EBV qPCR Kit</tradeName>
    <deviceName>EBV qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:21:33.959Z</lastUpdated>
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  <row>
    <udiDi>08684387211666</udiDi>
    <basicUdiDi>B-08684387211666</basicUdiDi>
    <tradeName>RevoDx Epstein-Barr Virus qPCR Kit (Quantitative)</tradeName>
    <deviceName>RevoDx Epstein-Barr Virus qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202216-250</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:51:04.103Z</lastUpdated>
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  <row>
    <udiDi>08595696304362</udiDi>
    <basicUdiDi>B-08595696304362</basicUdiDi>
    <tradeName>TaqPath™ Menu | 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58429</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:38.350Z</lastUpdated>
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  <row>
    <udiDi>08595696301163</udiDi>
    <basicUdiDi>B-08595696301163</basicUdiDi>
    <tradeName>GeneProof Epstein-Barr Virus (EBV) MC PCR Kit</tradeName>
    <deviceName>GeneProof Epstein-Barr Virus (EBV) MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBV/MC/205</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:12.434Z</lastUpdated>
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  <row>
    <udiDi>08594161958673</udiDi>
    <basicUdiDi>B-08594161958673</basicUdiDi>
    <tradeName>GeneProof Epstein-Barr Virus (EBV) MC PCR Kit</tradeName>
    <deviceName>GeneProof Epstein-Barr Virus (EBV) MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBV/MC/041</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:36.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050616041548</udiDi>
    <basicUdiDi>B-08050616041548</basicUdiDi>
    <tradeName>EBV DNA Quantitation (QT)</tradeName>
    <deviceName>EBV DNA Quantitation (QT)</deviceName>
    <manufacturerName>DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000029123</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBVDNAQT.CE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:10:24.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974858560297</udiDi>
    <basicUdiDi>B-06974858560297</basicUdiDi>
    <tradeName>06974858560297</tradeName>
    <deviceName>EB Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P177H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:58:18.445Z</lastUpdated>
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  <row>
    <udiDi>06974858560167</udiDi>
    <basicUdiDi>B-06974858560167</basicUdiDi>
    <tradeName>06974858560167</tradeName>
    <deviceName>EB Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P110H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:58:05.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974689627138</udiDi>
    <basicUdiDi>B-06974689627138</basicUdiDi>
    <tradeName>EBV nucleic acid digital PCR detection kit</tradeName>
    <deviceName>EBV nucleic acid digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13763-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:23.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974689626193</udiDi>
    <basicUdiDi>B-06974689626193</basicUdiDi>
    <tradeName>EBV nucleic acid digital PCR detection kit</tradeName>
    <deviceName>EBV nucleic acid digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13763-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:18.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971042229084</udiDi>
    <basicUdiDi>B-06971042229084</basicUdiDi>
    <tradeName>EBV Real Time PCR Kit</tradeName>
    <deviceName>EBV Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-0023-02-A+B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:23.270Z</lastUpdated>
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  <row>
    <udiDi>06971042229077</udiDi>
    <basicUdiDi>B-06971042229077</basicUdiDi>
    <tradeName>EBV Real Time PCR Kit</tradeName>
    <deviceName>EBV Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-0023-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:20.885Z</lastUpdated>
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  <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>
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  <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>
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    <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>
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    <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>
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