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<eudamedExport entity="devices">
  <row>
    <udiDi>D-CDX-170-01-40P3</udiDi>
    <basicUdiDi>B-CDX-170-01-40P3</basicUdiDi>
    <tradeName>GenomEra HSV 1/2, VZV + EV Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-170-01-40</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:37.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-170-01-20UN3</udiDi>
    <basicUdiDi>B-CDX-170-01-20UN3</basicUdiDi>
    <tradeName>GenomEra HSV 1/2, VZV + EV Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-170-01-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:36.848Z</lastUpdated>
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  <row>
    <udiDi>D-CDX-170-01-20NV</udiDi>
    <basicUdiDi>B-CDX-170-01-20NV</basicUdiDi>
    <tradeName>GenomEra HSV 1/2, VZV + EV Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-170-01-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:36.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-160-01-20UMC</udiDi>
    <basicUdiDi>B-CDX-160-01-20UMC</basicUdiDi>
    <tradeName>GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-160-01-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:35.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-160-01-20NA</udiDi>
    <basicUdiDi>B-CDX-160-01-20NA</basicUdiDi>
    <tradeName>GenomEra® SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-160-01-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:31.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-160-01-100UGV</udiDi>
    <basicUdiDi>B-CDX-160-01-100UGV</basicUdiDi>
    <tradeName>GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-160-01-100</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:30.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-160-01-100JX</udiDi>
    <basicUdiDi>B-CDX-160-01-100JX</basicUdiDi>
    <tradeName>GenomEra® SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-160-01-100</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:29.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-140-01-40UL8</udiDi>
    <basicUdiDi>B-CDX-140-01-40UL8</basicUdiDi>
    <tradeName>GenomEra SARS-CoV-2, Flu A/B + RSV Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-140-01-40</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:18.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-140-01-40MA</udiDi>
    <basicUdiDi>B-CDX-140-01-40MA</basicUdiDi>
    <tradeName>GenomEra® SARS-CoV-2, Flu A/B + RSV Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-140-01-40</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:17.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-140-01-20UKW</udiDi>
    <basicUdiDi>B-CDX-140-01-20UKW</basicUdiDi>
    <tradeName>GenomEra SARS-CoV-2, Flu A/B + RSV Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-140-01-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:16.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-140-01-100UF3</udiDi>
    <basicUdiDi>B-CDX-140-01-100UF3</basicUdiDi>
    <tradeName>GenomEra SARS-CoV-2, Flu A/B + RSV Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-140-01-100</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:16.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-140-01-100HH</udiDi>
    <basicUdiDi>B-CDX-140-01-100HH</basicUdiDi>
    <tradeName>GenomEra® SARS-CoV-2, Flu A/B + RSV Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-140-01-100</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:12.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111722141</udiDi>
    <basicUdiDi>88001117IPBA01MA03WR</basicUdiDi>
    <tradeName>08800111722141</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11FLU30A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T08:37:02.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111722158</udiDi>
    <basicUdiDi>88001117IPBA01MA03WR</basicUdiDi>
    <tradeName>08800111722158</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11FLU30A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T08:37:01.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698898741055</udiDi>
    <basicUdiDi>B-08698898741055</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion Covidenza Plus QLP 3.0 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>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1390102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:00:31.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698898741048</udiDi>
    <basicUdiDi>B-08698898741048</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion Covidenza Plus QLP 2.0 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>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1380102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:00:26.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698898741031</udiDi>
    <basicUdiDi>B-08698898741031</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion Covidenza Plus QLP 1.0 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>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1370102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:00:25.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698898741000</udiDi>
    <basicUdiDi>B-08698898741000</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion Covidenza QLP 1.0 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>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1360102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:00:08.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975578360303</udiDi>
    <basicUdiDi>B-06975578360303</basicUdiDi>
    <tradeName>06975578360303</tradeName>
    <deviceName>Human HerpesvirusNucleic Acid Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000262</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:18.589Z</lastUpdated>
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  <row>
    <udiDi>06975327120592</udiDi>
    <basicUdiDi>B-06975327120592</basicUdiDi>
    <tradeName>06975327120592</tradeName>
    <deviceName>SARS-CoV-2/Influenza A/Influenza B/RSV Nucleic Acid Test Card</deviceName>
    <manufacturerName>Guangzhou Pluslife Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025784</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RM1011702-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:28:44.137Z</lastUpdated>
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</eudamedExport>