<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CDX-100-01-20JQ</udiDi>
    <basicUdiDi>B-CDX-100-01-20JQ</basicUdiDi>
    <tradeName>GenomEra Norovirus Assay kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-100-01-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-100-01-40JW</udiDi>
    <basicUdiDi>B-CDX-100-01-40JW</basicUdiDi>
    <tradeName>GenomEra Norovirus Assay kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-100-01-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-130-01-100GS</udiDi>
    <basicUdiDi>B-CDX-130-01-100GS</basicUdiDi>
    <tradeName>GenomEra® SARS-CoV-2 Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-130-01-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-130-01-40LP</udiDi>
    <basicUdiDi>B-CDX-130-01-40LP</basicUdiDi>
    <tradeName>GenomEra® SARS-CoV-2 Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-130-01-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-130Q6</udiDi>
    <basicUdiDi>B-CDX-130Q6</basicUdiDi>
    <tradeName>GenomEra® SARS-CoV-2 Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-130-01-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.415Z</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-140-01-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.402Z</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-140-01-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-140Q9</udiDi>
    <basicUdiDi>B-CDX-140Q9</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-140-01-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-150-01-100J8</udiDi>
    <basicUdiDi>B-CDX-150-01-100J8</basicUdiDi>
    <tradeName>GenomEra® SARS-CoV-2 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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-150-01-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-150-01-20MP</udiDi>
    <basicUdiDi>B-CDX-150-01-20MP</basicUdiDi>
    <tradeName>GenomEra® SARS-CoV-2 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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-150-01-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.296Z</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-160-01-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.271Z</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-160-01-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.243Z</lastUpdated>
  </row>
  <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-170-01-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.218Z</lastUpdated>
  </row>
  <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-170-01-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-20-561BT</udiDi>
    <basicUdiDi>B-CDX-20-561BT</basicUdiDi>
    <tradeName>GenomEra® C. difficile Control Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-20-561</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-30-02-20TK</udiDi>
    <basicUdiDi>B-CDX-30-02-20TK</basicUdiDi>
    <tradeName>GenomEra® MRSA/SA Multi Swab Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-30-02-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-30-05-20U8</udiDi>
    <basicUdiDi>B-CDX-30-05-20U8</basicUdiDi>
    <tradeName>GenomEra® MRSA/SA AC Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-30-05-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-30-05-40UE</udiDi>
    <basicUdiDi>B-CDX-30-05-40UE</basicUdiDi>
    <tradeName>GenomEra® MRSA/SA AC Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-30-05-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-40-01-20TX</udiDi>
    <basicUdiDi>B-CDX-40-01-20TX</basicUdiDi>
    <tradeName>GenomEra® C. difficile Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-40-01-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-40-01-40U5</udiDi>
    <basicUdiDi>B-CDX-40-01-40U5</basicUdiDi>
    <tradeName>GenomEra® C. difficile Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-40-01-40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:11.036Z</lastUpdated>
  </row>
</eudamedExport>