<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809240102442</udiDi>
    <basicUdiDi>B-08809240102442</basicUdiDi>
    <tradeName>Allplex™ 2019-nCoV Assay</tradeName>
    <deviceName>Allplex™ 2019-nCoV Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP10244Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:45:09.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800097500023</udiDi>
    <basicUdiDi>B-08800097500023</basicUdiDi>
    <tradeName>PaxView® SARS-CoV-2 real-time RT-PCR Kit</tradeName>
    <deviceName>PaxView® SARS-CoV-2 real-time RT-PCR Kit</deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0502</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:13.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056369104</udiDi>
    <basicUdiDi>B-08800056369104</basicUdiDi>
    <tradeName>PowerChek™ SARS-CoV-2 Advanced Real-time PCR Kit</tradeName>
    <deviceName>PowerChek™ SARS-CoV-2 Advanced Real-time PCR Kit</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IR6906</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:48.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056369029</udiDi>
    <basicUdiDi>B-08800056369029</basicUdiDi>
    <tradeName>PowerChek™ SARS-CoV-2 Real-time PCR Kit</tradeName>
    <deviceName>PowerChek™ SARS-CoV-2 Real-time PCR Kit</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IR6902</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:46.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056364031</udiDi>
    <basicUdiDi>B-08800056364031</basicUdiDi>
    <tradeName>PowerChek™ Coronavirus 229E / OC43 / NL63 / HKU1 Real-time PCR Kit Ver.1.0</tradeName>
    <deviceName>PowerChek™ Coronavirus 229E / OC43 / NL63 / HKU1 Real-time PCR Kit Ver.1.0</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R6410TA</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:44.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045517004</udiDi>
    <basicUdiDi>54200455DIAGAPTSARSCOV2CC</basicUdiDi>
    <tradeName>Aptima SARS-CoV-2 Assay</tradeName>
    <deviceName></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></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:45:04.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045517035</udiDi>
    <basicUdiDi>54200455DIAGAPTSARSCOV2CC</basicUdiDi>
    <tradeName>Aptima SARS-CoV-2 Assay Controls Kit</tradeName>
    <deviceName></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-07882</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:45:04.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684998275903</udiDi>
    <basicUdiDi>B-08684998275903</basicUdiDi>
    <tradeName>LyoSens  SARS-CoV-2 qPCR Kit</tradeName>
    <deviceName>SARS-CoV-2 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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:21:40.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212762</udiDi>
    <basicUdiDi>B-08684387212762</basicUdiDi>
    <tradeName>RevoDx Coronavirus 229E/NL63/OC43/HKU1 qPCR Kit</tradeName>
    <deviceName>RevoDx Coronavirus 229E/NL63/OC43/HKU1 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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202339-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:54:47.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212755</udiDi>
    <basicUdiDi>B-08684387212755</basicUdiDi>
    <tradeName>RevoDx Coronavirus 229E/NL63/OC43/HKU1 qPCR Kit</tradeName>
    <deviceName>RevoDx Coronavirus 229E/NL63/OC43/HKU1 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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202339-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:54:46.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387210171</udiDi>
    <basicUdiDi>B-08684387210171</basicUdiDi>
    <tradeName>RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free)</tradeName>
    <deviceName>RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free)</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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202221-480</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:46:35.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387210058</udiDi>
    <basicUdiDi>B-08684387210058</basicUdiDi>
    <tradeName>RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free)</tradeName>
    <deviceName>RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free)</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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202221-384</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:46:06.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387210041</udiDi>
    <basicUdiDi>B-08684387210041</basicUdiDi>
    <tradeName>RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free)</tradeName>
    <deviceName>RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free)</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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202221-96</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:46:05.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300760</udiDi>
    <basicUdiDi>B-08595696300760</basicUdiDi>
    <tradeName>GeneProof SARS-CoV-2 Advanced PCR Kit</tradeName>
    <deviceName>GeneProof SARS-CoV-2 Advanced 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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV2A/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:55.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300104</udiDi>
    <basicUdiDi>B-08595696300104</basicUdiDi>
    <tradeName>GeneProof SARS-CoV-2 Screening MC PCR Kit</tradeName>
    <deviceName>GeneProof SARS-CoV-2 Screening 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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV2S/MC/190</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:53.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300746</udiDi>
    <basicUdiDi>B-08595696300746</basicUdiDi>
    <tradeName>GeneProof SARS-CoV-2 Advanced PCR Kit</tradeName>
    <deviceName>GeneProof SARS-CoV-2 Advanced 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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV2A/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:51.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300081</udiDi>
    <basicUdiDi>B-08595696300081</basicUdiDi>
    <tradeName>GeneProof SARS-CoV-2 Screening MC PCR Kit</tradeName>
    <deviceName>GeneProof SARS-CoV-2 Screening 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>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV2S/MC/038</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:36.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977883370008</udiDi>
    <basicUdiDi>B-06977883370008</basicUdiDi>
    <tradeName>06977883370008</tradeName>
    <deviceName>ULSEN ®SARS-CoV-2 Whole Genome Capture Kit Instruction</deviceName>
    <manufacturerName>Beijing Microfuture Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000048064</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ULSEN ®SARS-CoV-2 Whole Genome Capture Kit Instruction</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:30:51.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975447582058</udiDi>
    <basicUdiDi>B-06975447582058</basicUdiDi>
    <tradeName>06975447582058</tradeName>
    <deviceName>SARS-2-CoV(Covid-19) nucleic acid detection cartridge (Real-time reverse transcription PCR method)</deviceName>
    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001552</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106-0050-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:01.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975327120028</udiDi>
    <basicUdiDi>B-06975327120028</basicUdiDi>
    <tradeName>Pluslife SARS-CoV-2 Card</tradeName>
    <deviceName>SARS-CoV-2 Nucleic Acid Testing Card</deviceName>
    <manufacturerName>Guangzhou Pluslife Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025784</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RM1010202-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:28:31.344Z</lastUpdated>
  </row>
</eudamedExport>