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<eudamedExport entity="devices">
  <row>
    <udiDi>D-EBX-039-25DN</udiDi>
    <basicUdiDi>B-EBX-039-25DN</basicUdiDi>
    <tradeName>EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)</tradeName>
    <deviceName>EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011299</emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-039-25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:25.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-039-10049</udiDi>
    <basicUdiDi>B-EBX-039-10049</basicUdiDi>
    <tradeName>EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)</tradeName>
    <deviceName>EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011299</emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-039-100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:25.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-039-50DM</udiDi>
    <basicUdiDi>B-EBX-039-50DM</basicUdiDi>
    <tradeName>EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)</tradeName>
    <deviceName>EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011299</emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-039-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:25.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436040321614</udiDi>
    <basicUdiDi>843604032MBC01101ZG</basicUdiDi>
    <tradeName>AMPLIRUN® CHLAMYDOPHILA PNEUMONIAE DNA CONTROL</tradeName>
    <deviceName>AMPLIRUN® CHLAMYDOPHILA PNEUMONIAE DNA CONTROL</deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBC011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:23.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436040321515</udiDi>
    <basicUdiDi>843604032MBC00101Z9</basicUdiDi>
    <tradeName>AMPLIRUN® ADENOVIRUS DNA CONTROL</tradeName>
    <deviceName>AMPLIRUN® ADENOVIRUS DNA CONTROL</deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBC001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:22.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-042-25CG</udiDi>
    <basicUdiDi>B-EBX-042-25CG</basicUdiDi>
    <tradeName>EurobioPlex FluCoSyn</tradeName>
    <deviceName>EurobioPlex FluCoSyn</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-042-25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:18.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-042-50CF</udiDi>
    <basicUdiDi>B-EBX-042-50CF</basicUdiDi>
    <tradeName>EurobioPlex FluCoSyn</tradeName>
    <deviceName>EurobioPlex FluCoSyn</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-042-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:17.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-042-10029</udiDi>
    <basicUdiDi>B-EBX-042-10029</basicUdiDi>
    <tradeName>EurobioPlex FluCoSyn</tradeName>
    <deviceName>EurobioPlex FluCoSyn</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-042-100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:17.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-042-2002E</udiDi>
    <basicUdiDi>B-EBX-042-2002E</basicUdiDi>
    <tradeName>EurobioPlex FluCoSyn</tradeName>
    <deviceName>EurobioPlex FluCoSyn</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-042-200</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:17.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-042-60032</udiDi>
    <basicUdiDi>B-EBX-042-60032</basicUdiDi>
    <tradeName>EurobioPlex FluCoSyn</tradeName>
    <deviceName>EurobioPlex FluCoSyn</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-042-600</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:17.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382904437473</udiDi>
    <basicUdiDi>038290UDTHKMDJEX</basicUdiDi>
    <tradeName>VIPER</tradeName>
    <deviceName>BD Key Card for the BD Viper™ LT System</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041099</emdnCode>
    <emdnDescription>HPV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>443747</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:46:20.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260080</udiDi>
    <basicUdiDi>84354402_MDXRESP_ADUWH</basicUdiDi>
    <tradeName>VIASURE Adenovirus plus Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Adenovirus plus Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ADU101L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:30:07.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440258353</udiDi>
    <basicUdiDi>84354402_MDXMENIN_NEUZE</basicUdiDi>
    <tradeName>VIASURE ADV, CMV, EBV &amp; PB19 Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE ADV, CMV, EBV &amp; PB19 Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-NEU101L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:30:06.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440219439</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_BLDPX</basicUdiDi>
    <tradeName>VIASURE Blastocystis hominis + Dientamoeba fragilis Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Blastocystis hominis + Dientamoeba fragilis Real Time PCR Detection Kit</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>W0105050399</emdnCode>
    <emdnDescription>OTHER PARASITOLOGY - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-BLD196T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:30:05.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440209775</udiDi>
    <basicUdiDi>84354402_MDXVECTOR_CHAH5</basicUdiDi>
    <tradeName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Trypanosoma cruzi Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050302</emdnCode>
    <emdnDescription>CHAGAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CHA106H</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:30:03.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979890910673</udiDi>
    <basicUdiDi>69798909110006CP</basicUdiDi>
    <tradeName>Influenza A/B Antigen Rapid Test</tradeName>
    <deviceName></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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLU-522b-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:54:11.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979890910666</udiDi>
    <basicUdiDi>69798909110004CK</basicUdiDi>
    <tradeName>Flu A&amp;B/SARS-CoV-2 Antigen Combo Test</tradeName>
    <deviceName></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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVC-532b-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:54:07.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979890910659</udiDi>
    <basicUdiDi>69798909110057D8</basicUdiDi>
    <tradeName>8-in-1 Respiratory Antigen Combo Rapid Test</tradeName>
    <deviceName></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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVC-585b-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:54:05.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979890910642</udiDi>
    <basicUdiDi>69798909110058DA</basicUdiDi>
    <tradeName>10-in-1 Respiratory Antigen Combo Rapid Test</tradeName>
    <deviceName></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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVC-5105a-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:54:04.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979890910635</udiDi>
    <basicUdiDi>69798909110038D4</basicUdiDi>
    <tradeName>H. pylori Antigen Rapid Test</tradeName>
    <deviceName></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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-602a-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:54:03.063Z</lastUpdated>
  </row>
</eudamedExport>