<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-5713915CD005LJAE</udiDi>
    <basicUdiDi>B-5713915CD005LJAE</basicUdiDi>
    <tradeName>CoviFLU</tradeName>
    <deviceName>CoviFLU COVID-19 &amp; Influenza RT-qPCR Assay</deviceName>
    <manufacturerName>PentaBase A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023157</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8177, 8180</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:31.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940008000</udiDi>
    <basicUdiDi>B-07332940008000</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® Xpress CoV-2/Flu/RSV 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>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XP3COV2/FLU/RSV-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:56:12.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNVC-CED-02X4</udiDi>
    <basicUdiDi>B-TD-HNVC-CED-02X4</basicUdiDi>
    <tradeName>D-TD-HNVC-CED-02X4</tradeName>
    <deviceName>Multiple-type Respiratory Pathogen Nucleic Acid Kit (Fluorescent PCR)</deviceName>
    <manufacturerName>Henan Vacure Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023292</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:54.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RP23021VA5</udiDi>
    <basicUdiDi>B-RP23021VA5</basicUdiDi>
    <tradeName>Cowingene Respiratory Pathogen Panel 21  Detection Kit</tradeName>
    <deviceName>Cowingene Respiratory Pathogen Panel 21 Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP23021V</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:29.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RP13MA</udiDi>
    <basicUdiDi>B-RP13MA</basicUdiDi>
    <tradeName>Cowingene Respiratory Pathogen Panel Detection Kit</tradeName>
    <deviceName>Cowingene Respiratory Pathogen Panel Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP13021W, RP13022S, RP14021W, RP16023P, RP19023P RP14022U,</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:28.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RP2-P7-10YM</udiDi>
    <basicUdiDi>B-RP2-P7-10YM</basicUdiDi>
    <tradeName>Respiratory Panel 2</tradeName>
    <deviceName>Respiratory Panel 2</deviceName>
    <manufacturerName>FlashDx Shenzhen Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000025748</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP2-P7-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:28.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RP1-P10-10NG</udiDi>
    <basicUdiDi>B-RP1-P10-10NG</basicUdiDi>
    <tradeName>Respiratory Panel 1.0</tradeName>
    <deviceName>Respiratory Panel 1.0</deviceName>
    <manufacturerName>FlashDx Shenzhen Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000025748</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP1-P10-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:23.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RP03M7</udiDi>
    <basicUdiDi>B-RP03M7</basicUdiDi>
    <tradeName>Cowingene Influenza A/B and RSV Detection Kit</tradeName>
    <deviceName>Cowingene Influenza A/B and RSV Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP03021X, RP03022X, RP03023W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:09.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RP-P10-10XX</udiDi>
    <basicUdiDi>B-RP-P10-10XX</basicUdiDi>
    <tradeName>Respiratory Panel 1.1</tradeName>
    <deviceName>Respiratory Panel 1.1</deviceName>
    <manufacturerName>FlashDx Shenzhen Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000025748</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP-P10-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:05.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90508ZM</udiDi>
    <basicUdiDi>B-K90508ZM</basicUdiDi>
    <tradeName>D-K90508ZM</tradeName>
    <deviceName>Influenza &amp; SARS-CoV-2  Antigen Combo Test Kit（Colloidal Gold Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:38:28.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MCRVP17001A4</udiDi>
    <basicUdiDi>B-G2MCRVP17001A4</basicUdiDi>
    <tradeName>Comprehensive Respiratory Virus Panel</tradeName>
    <deviceName>Comprehensive Respiratory Virus Panel</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2MCRVP17001-ill, G2MCRVP17001-TF</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:36.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Cov2P4-10HND5</udiDi>
    <basicUdiDi>B-Cov2P4-10HND5</basicUdiDi>
    <tradeName>SARS-CoV-2/FluA/FluB/RSV  Test</tradeName>
    <deviceName>SARS-CoV-2/FluA/FluB/RSV  Test</deviceName>
    <manufacturerName>FlashDx Shenzhen Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000025748</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cov2P4-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:14:28.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CoV2-207D</udiDi>
    <basicUdiDi>B-CoV2-207D</basicUdiDi>
    <tradeName>SARS-CoV-2 Test</tradeName>
    <deviceName>SARS-CoV-2 Test</deviceName>
    <manufacturerName>FlashDx Shenzhen Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000025748</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CoV2-20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:14:21.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CoV2-107A</udiDi>
    <basicUdiDi>B-CoV2-107A</basicUdiDi>
    <tradeName>SARS-CoV-2 Test</tradeName>
    <deviceName>SARS-CoV-2 Test</deviceName>
    <manufacturerName>FlashDx Shenzhen Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000025748</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CoV2-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:14:21.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8684387210188CU</udiDi>
    <basicUdiDi>B-8684387210188CU</basicUdiDi>
    <tradeName>RevoDx Respiratory-24 Pathogen Detection Kit</tradeName>
    <deviceName>RevoDx Respiratory-24 Pathogen Detection 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>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202323</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:27:11.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>37700267940128</udiDi>
    <basicUdiDi>B-37700267940128</basicUdiDi>
    <tradeName>SirYus Covidiag +</tradeName>
    <deviceName>SirYus Covidiag +</deviceName>
    <manufacturerName>Innobiochips</manufacturerName>
    <manufacturerSrn>FR-MF-000009584</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2009</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:50:49.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>37700267940050</udiDi>
    <basicUdiDi>B-37700267940050</basicUdiDi>
    <tradeName>SirYus Covidiag</tradeName>
    <deviceName>SirYus Covidiag</deviceName>
    <manufacturerName>Innobiochips</manufacturerName>
    <manufacturerSrn>FR-MF-000009584</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:50:33.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351179002090</udiDi>
    <basicUdiDi>B-09351179002090</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen® SARS CoV-2 Detection Kit</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RP012-HT</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:49:42.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>09351179002021</udiDi>
    <basicUdiDi>B-09351179002021</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen Respiratory Pathogen Detection Kit (RP007)</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RP007-HT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:49:41.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044007118</udiDi>
    <basicUdiDi>B-09343044007118</basicUdiDi>
    <tradeName>RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well Step 1</tradeName>
    <deviceName>RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80081S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:47:01.865Z</lastUpdated>
  </row>
</eudamedExport>