<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08435440207344</udiDi>
    <basicUdiDi>84354402IDXGASTROB_AT6W</basicUdiDi>
    <tradeName>CerTest Astrovirus</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT820001VCC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:40.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FLU-B22bGV</udiDi>
    <basicUdiDi>B-FLU-B22bGV</basicUdiDi>
    <tradeName>Influenza A+B Antigen Rapid Test</tradeName>
    <deviceName>Influenza A+B Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLU-B22b</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:36:21.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FLU-522bE9</udiDi>
    <basicUdiDi>B-FLU-522bE9</basicUdiDi>
    <tradeName>Influenza A/B Antigen Rapid Test</tradeName>
    <deviceName>Influenza A/B Antigen Rapid Test</deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLU-522b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:36:19.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823COV7S67</udiDi>
    <basicUdiDi>B-FIMF16823COV7S67</basicUdiDi>
    <tradeName>D-FIMF16823COV7S67</tradeName>
    <deviceName>Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Nasal Swab)</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-07-S</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:25.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823COV06SEQ</udiDi>
    <basicUdiDi>B-FIMF16823COV06SEQ</basicUdiDi>
    <tradeName>D-FIMF16823COV06SEQ</tradeName>
    <deviceName>Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Nasopharyngeal Swab)</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-06-S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:24.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823COV062STG</udiDi>
    <basicUdiDi>B-FIMF16823COV062STG</basicUdiDi>
    <tradeName>D-FIMF16823COV062STG</tradeName>
    <deviceName>Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab)</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-062-S</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:20.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823COV061STD</udiDi>
    <basicUdiDi>B-FIMF16823COV061STD</basicUdiDi>
    <tradeName>D-FIMF16823COV061STD</tradeName>
    <deviceName>Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Saliva)</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-061-S</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:20.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823CLACOV19AGVIAB</udiDi>
    <basicUdiDi>B-FIMF16823CLACOV19AGVIAB</basicUdiDi>
    <tradeName>D-FIMF16823CLACOV19AGVIAB</tradeName>
    <deviceName>Clarity COVID-19 Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLA-COV19AG-VIS</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:19.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF168237575STREPAxxGG</udiDi>
    <basicUdiDi>B-FIMF168237575STREPAxxGG</basicUdiDi>
    <tradeName>D-FIMF168237575STREPAxxGG</tradeName>
    <deviceName>Strep A test kit</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>75-75STREPA-xx</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:18.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823102261KZ</udiDi>
    <basicUdiDi>B-FIMF16823102261KZ</basicUdiDi>
    <tradeName>D-FIMF16823102261KZ</tradeName>
    <deviceName>Sienna COVID-19 Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab)</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102261</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:11.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823102251KW</udiDi>
    <basicUdiDi>B-FIMF16823102251KW</basicUdiDi>
    <tradeName>D-FIMF16823102251KW</tradeName>
    <deviceName>Sienna COVID-19 Antigen Rapid Test Cassette (Saliva)</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102251</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:07.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF1682310224XN7</udiDi>
    <basicUdiDi>B-FIMF1682310224XN7</basicUdiDi>
    <tradeName>D-FIMF1682310224XN7</tradeName>
    <deviceName>Sienna COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab)</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10224X</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:07.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCCOV-502aHG3B</udiDi>
    <basicUdiDi>B-FCCOV-502aHG3B</basicUdiDi>
    <tradeName>SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)</tradeName>
    <deviceName>SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCCOV-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:18:11.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCCOV-502a3D</udiDi>
    <basicUdiDi>B-FCCOV-502a3D</basicUdiDi>
    <tradeName>SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)</tradeName>
    <deviceName>SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCCOV-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:18:10.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F131-10615-201RJ</udiDi>
    <basicUdiDi>B-F131-10615-201RJ</basicUdiDi>
    <tradeName>Flowflex</tradeName>
    <deviceName>Flowflex Dengue NS1 Ag FIA Test</deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F131-10615-201</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:13:36.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-F131-10611-201Q6</udiDi>
    <basicUdiDi>B-F131-10611-201Q6</basicUdiDi>
    <tradeName>FIAflex</tradeName>
    <deviceName>FIAflex Dengue NS1 Ag FIA Test</deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F131-10611-201</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:13:35.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DENC-435aWK</udiDi>
    <basicUdiDi>B-DENC-435aWK</basicUdiDi>
    <tradeName>Dengue IgG/IgM and NS1 Combo Rapid Test</tradeName>
    <deviceName>Dengue IgG/IgM and NS1 Combo Rapid Test</deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DENC-435a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:08:06.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEN-422a68</udiDi>
    <basicUdiDi>B-DEN-422a68</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test</tradeName>
    <deviceName>Dengue IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEN-422a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:07:51.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEN-402b5Y</udiDi>
    <basicUdiDi>B-DEN-402b5Y</basicUdiDi>
    <tradeName>Dengue NS1 Ag Rapid Test</tradeName>
    <deviceName>Dengue NS1 Ag Rapid Test</deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEN-402b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:07:50.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEAG-D02bTV</udiDi>
    <basicUdiDi>B-DEAG-D02bTV</basicUdiDi>
    <tradeName>Dengue NS1 Rapid Test</tradeName>
    <deviceName>Dengue NS1 Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEAG-D02b</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:24:38.700Z</lastUpdated>
  </row>
</eudamedExport>