<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-EBX-028QN</udiDi>
    <basicUdiDi>B-EBX-028QN</basicUdiDi>
    <tradeName>EurobioPlex BK virus / JC virus</tradeName>
    <deviceName>EurobioPlex BK virus / JC virus</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-028</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:45.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-028-48DG</udiDi>
    <basicUdiDi>B-EBX-028-48DG</basicUdiDi>
    <tradeName>EurobioPlex BK virus / JC virus</tradeName>
    <deviceName>EurobioPlex BK virus / JC virus</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-028-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:44.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-028-24D2</udiDi>
    <basicUdiDi>B-EBX-028-24D2</basicUdiDi>
    <tradeName>EurobioPlex BK virus / JC virus</tradeName>
    <deviceName>EurobioPlex BK virus / JC virus</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-028-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:43.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-022-36BX</udiDi>
    <basicUdiDi>B-EBX-022-36BX</basicUdiDi>
    <tradeName>EurobioPlex Méningite bactérienne materno-foetale</tradeName>
    <deviceName>EurobioPlex Méningite bactérienne materno-foetale</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070505</emdnCode>
    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-022-36</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:31.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-022-09BU</udiDi>
    <basicUdiDi>B-EBX-022-09BU</basicUdiDi>
    <tradeName>EurobioPlex Méningite bactérienne materno-foetale</tradeName>
    <deviceName>EurobioPlex Méningite bactérienne materno-foetale</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070505</emdnCode>
    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-022-09</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:31.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-020-36BH</udiDi>
    <basicUdiDi>B-EBX-020-36BH</basicUdiDi>
    <tradeName>EurobioPlex Méningite bactérienne communautaire</tradeName>
    <deviceName>EurobioPlex Méningite bactérienne communautaire</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070505</emdnCode>
    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-020-36</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:29.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-020-09BE</udiDi>
    <basicUdiDi>B-EBX-020-09BE</basicUdiDi>
    <tradeName>EurobioPlex Méningite bactérienne communautaire</tradeName>
    <deviceName>EurobioPlex Méningite bactérienne communautaire</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070505</emdnCode>
    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-020-09</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:27.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-013Q9</udiDi>
    <basicUdiDi>B-EBX-013Q9</basicUdiDi>
    <tradeName>EurobioPlex Bartonella</tradeName>
    <deviceName>EurobioPlex Bartonella</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-013</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:05.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-013-48C2</udiDi>
    <basicUdiDi>B-EBX-013-48C2</basicUdiDi>
    <tradeName>EurobioPlex Bartonella</tradeName>
    <deviceName>EurobioPlex Bartonella</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-013-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:04.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-013-24BL</udiDi>
    <basicUdiDi>B-EBX-013-24BL</basicUdiDi>
    <tradeName>EurobioPlex Bartonella</tradeName>
    <deviceName>EurobioPlex Bartonella</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-013-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:04.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-FICRYGLD257D</udiDi>
    <basicUdiDi>B-D-FICRYGLD257D</basicUdiDi>
    <tradeName>Cryptosporidium Ag and Giardia Lamblia Ag  Combo Test Device-Feces</tradeName>
    <deviceName>Cryptosporidium Ag and Giardia Lamblia Ag  Combo Test Device-Feces</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-FICRYGLD25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:20.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-FICRYGLD106Y</udiDi>
    <basicUdiDi>B-D-FICRYGLD106Y</basicUdiDi>
    <tradeName>Cryptosporidium Ag and Giardia Lamblia Ag  Combo Test Device-Feces</tradeName>
    <deviceName>Cryptosporidium Ag and Giardia Lamblia Ag  Combo Test Device-Feces</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-FICRYGLD10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:18.775Z</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-CRE-P5-10Y6</udiDi>
    <basicUdiDi>B-CRE-P5-10Y6</basicUdiDi>
    <tradeName>CRE Test</tradeName>
    <deviceName>CRE 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>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRE-P5-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:20:19.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240101681</udiDi>
    <basicUdiDi>924010GI97010FP</basicUdiDi>
    <tradeName>Allplex™ GI-Virus Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GI9701X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T03:45:22.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABVP8E-107J</udiDi>
    <basicUdiDi>B-ABVP8E-107J</basicUdiDi>
    <tradeName>Arbovirus Panel (ENA)</tradeName>
    <deviceName>Arbovirus Panel (ENA)</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>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABVP8E-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:37.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABC-K-001H5</udiDi>
    <basicUdiDi>B-ABC-K-001H5</basicUdiDi>
    <tradeName>Logix Smart ABC (Influenza A/B, SARS-Cov-2)</tradeName>
    <deviceName>Logix Smart ABC (Influenza A/B, SARS-CoV-2)</deviceName>
    <manufacturerName>Co-Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000036425</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABC-K-001</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:17:37.934Z</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>
</eudamedExport>