<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08435440213598</udiDi>
    <basicUdiDi>84354402_MDXRESP_NCO29B</basicUdiDi>
    <tradeName>VIASURE SARS-CoV-2 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-NCO213HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:20.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440213604</udiDi>
    <basicUdiDi>84354402_MDXRESP_NCO29B</basicUdiDi>
    <tradeName>VIASURE SARS-CoV-2 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-NCO296TE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:19.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440242888</udiDi>
    <basicUdiDi>84354402_MDXRESP_NCO29B</basicUdiDi>
    <tradeName>VIASURE SARS-CoV-2 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-NCO201E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:05.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440213611</udiDi>
    <basicUdiDi>84354402_MDXRESP_NCO29B</basicUdiDi>
    <tradeName>VIASURE SARS-CoV-2 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-NCO236E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:05.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440213628</udiDi>
    <basicUdiDi>84354402_MDXRESP_NCO29B</basicUdiDi>
    <tradeName>VIASURE SARS-CoV-2 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-NCO272E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:04.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>37604277000196</udiDi>
    <basicUdiDi>B-37604277000196</basicUdiDi>
    <tradeName>AD Nucléis direct SARS-CoV-2_1-step RTCPR 48R</tradeName>
    <deviceName>AD Nucléis direct SARS-CoV-2_1-step RTCPR 48R</deviceName>
    <manufacturerName>AD Nucleis</manufacturerName>
    <manufacturerSrn>FR-MF-000002215</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HQS_DICoV2_IVD48R</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-23T06:39:12.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>37604277000028</udiDi>
    <basicUdiDi>B-37604277000028</basicUdiDi>
    <tradeName>AD Nucléis direct SARS-CoV-2_1-step RTCPR 96R</tradeName>
    <deviceName>AD Nucléis direct SARS-CoV-2_1-step RTCPR 96R</deviceName>
    <manufacturerName>AD Nucleis</manufacturerName>
    <manufacturerSrn>FR-MF-000002215</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HQS_DICoV2_IVD96R</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-23T06:39:11.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095210532</udiDi>
    <basicUdiDi>4049095UN68100000TT</basicUdiDi>
    <tradeName>04049095210532</tradeName>
    <deviceName>RIDA®UNITY SARS-CoV-2 DT</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN6810</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T05:01:18.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940009526</udiDi>
    <basicUdiDi>B-07332940009526</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® Xpress SARS-CoV-2</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XPRSARS-COV2-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:56:18.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940007928</udiDi>
    <basicUdiDi>B-07332940007928</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® Xpress CoV-2 plus</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XP3SARS-COV2-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:56:12.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIPCOV61110B</udiDi>
    <basicUdiDi>B-+ENTIPCOV61110B</basicUdiDi>
    <tradeName>+ENTIPCOV61110B</tradeName>
    <deviceName>GSD NovaPrime® TSP SARS-CoV-2</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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCOV6111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:16:36.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIPCOV61130D</udiDi>
    <basicUdiDi>B-+ENTIPCOV61130D</basicUdiDi>
    <tradeName>+ENTIPCOV61130D</tradeName>
    <deviceName>GSD NovaPrime® TSP SARS-CoV-2</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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCOV6113</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:16:35.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045516991</udiDi>
    <basicUdiDi>54200455DIAGAPTSARSCOV2CC</basicUdiDi>
    <tradeName>Aptima SARS-CoV-2 Assay</tradeName>
    <deviceName>Aptima SARS-CoV-2 Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-07881</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:02:44.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884999049192</udiDi>
    <basicUdiDi>0884999AMN0006W8</basicUdiDi>
    <tradeName>Alinity m</tradeName>
    <deviceName>ALINITY M SARS-COV-2</deviceName>
    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009457</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N78-080</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:23:47.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>80845357043708</udiDi>
    <basicUdiDi>08453570ABT-0014T</basicUdiDi>
    <tradeName>80845357043708</tradeName>
    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[ABT-001] QC Sets and Panels: Helix Elite™ SARS-CoV-2 Verification Panel</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:50.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357043570</udiDi>
    <basicUdiDi>08453570HE0066NS32</basicUdiDi>
    <tradeName>10845357043570</tradeName>
    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0066NS] Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 Whole Virus (Swab)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:52.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357043563</udiDi>
    <basicUdiDi>08453570HE0065NZF</basicUdiDi>
    <tradeName>10845357043563</tradeName>
    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0065N] Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 Whole Virus (Pellet)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:50.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382904453732</udiDi>
    <basicUdiDi>038290QOYRIOCFPE</basicUdiDi>
    <tradeName>MAX</tradeName>
    <deviceName>BD Respiratory Viral Panel for BD MAX™ System</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>445373</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:44:07.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KSC2-AB692F</udiDi>
    <basicUdiDi>B-KSC2-AB692F</basicUdiDi>
    <tradeName>SARS-CoV-2 RT-qPCR DETECTION KIT</tradeName>
    <deviceName>SARS-CoV-2 RT-qPCR DETECTION KIT</deviceName>
    <manufacturerName>APPOLON BIOTECK</manufacturerName>
    <manufacturerSrn>FR-MF-000022234</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KSC2-AB69</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:47:44.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302016674</udiDi>
    <basicUdiDi>B-10190302016674</basicUdiDi>
    <tradeName>TaqPath™ COVID-19 Control</tradeName>
    <deviceName>TaqPath™ COVID-19 Control</deviceName>
    <manufacturerName>Life Technologies Corporation; Thermo Fisher Life Sciences</manufacturerName>
    <manufacturerSrn>US-MF-000026189</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>966116 (A51738)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:40:15.493Z</lastUpdated>
  </row>
</eudamedExport>