<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00815381020208</udiDi>
    <basicUdiDi>357302BUDI000006SN</basicUdiDi>
    <tradeName>BioFire® Joint Infection (JI) Panel</tradeName>
    <deviceName>BioFire® Joint Infection (JI) Panel</deviceName>
    <manufacturerName>BioFire Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003311</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFIT-ASY-0135</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:20.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DBP01UK</udiDi>
    <basicUdiDi>B-DBP01UK</basicUdiDi>
    <tradeName>D-DBP01UK</tradeName>
    <deviceName>Blood Pathogens and Drug Resistance Genes Digital PCR Detection Kit</deviceName>
    <manufacturerName>Hysen Biotech.Inc</manufacturerName>
    <manufacturerSrn>KR-MF-000048224</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DBP01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:58:46.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130CRTI701AWBSW</udiDi>
    <basicUdiDi>B-697603130CRTI701AWBSW</basicUdiDi>
    <tradeName>D-697603130CRTI701AWBSW</tradeName>
    <deviceName>GeneStream RTI-7 Assay</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRTI701A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:19.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130CRTI601AW4RP</udiDi>
    <basicUdiDi>B-697603130CRTI601AW4RP</basicUdiDi>
    <tradeName>D-697603130CRTI601AW4RP</tradeName>
    <deviceName>GeneStream SARS-CoV-2/FluA/FluB/RSV/AdV/RhV Assay</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRTI601A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:18.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130APA019C8E</udiDi>
    <basicUdiDi>B-697603130APA019C8E</basicUdiDi>
    <tradeName>D-697603130APA019C8E</tradeName>
    <deviceName>Human Parainfluenza Virus Type Ⅰ/Ⅲ &amp; Adenovirus Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APA01,APA01D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:56.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130AFR019TB9</udiDi>
    <basicUdiDi>B-697603130AFR019TB9</basicUdiDi>
    <tradeName>D-697603130AFR019TB9</tradeName>
    <deviceName>Influenza A/ B and Respiratory Syncytial Virus Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFR01,AFR01D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:53.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNVC-CED-05XA</udiDi>
    <basicUdiDi>B-TD-HNVC-CED-05XA</basicUdiDi>
    <tradeName>D-TD-HNVC-CED-05XA</tradeName>
    <deviceName>Neisseria Gonorrhoeae &amp; Ureaplasma Urealyticum 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>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:58:00.306Z</lastUpdated>
  </row>
  <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-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-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-81649002CRTI701ASJHB</udiDi>
    <basicUdiDi>B-81649002CRTI701ASJHB</basicUdiDi>
    <tradeName>D-81649002CRTI701ASJHB</tradeName>
    <deviceName>GeneStream RTI-7 Assay</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRTI701A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:05:10.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002CRTI601ASBGE</udiDi>
    <basicUdiDi>B-81649002CRTI601ASBGE</basicUdiDi>
    <tradeName>D-81649002CRTI601ASBGE</tradeName>
    <deviceName>GeneStream SARS-CoV-2/FluA/FluB/RSV/AdV/RhV Assay</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRTI601A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:05:07.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002CFFCR01AJ45L</udiDi>
    <basicUdiDi>B-81649002CFFCR01AJ45L</basicUdiDi>
    <tradeName>D-81649002CFFCR01AJ45L</tradeName>
    <deviceName>GeneStream Flu A/Flu B/CoV-2/RSV Assay</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFFCR01A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:04:51.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245349</udiDi>
    <basicUdiDi>B-15065026245349</basicUdiDi>
    <tradeName>TruDerma</tradeName>
    <deviceName>Dermatophyte PCR Test Kit</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TM10002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:38:04.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044006470</udiDi>
    <basicUdiDi>B-09343044006470</basicUdiDi>
    <tradeName>RIDA®Plex Staphylococcus and VRE 8 well Step 2</tradeName>
    <deviceName>RIDA®Plex Staphylococcus and VRE 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>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21340P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:44:44.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044006487</udiDi>
    <basicUdiDi>B-09343044006487</basicUdiDi>
    <tradeName>RIDA®Plex Staphylococcus and VRE 8 well Step 1</tradeName>
    <deviceName>RIDA®Plex Staphylococcus and VRE 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>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21340S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:44:44.092Z</lastUpdated>
  </row>
</eudamedExport>