<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08594161956662</udiDi>
    <basicUdiDi>B-08594161956662</basicUdiDi>
    <tradeName>GeneProof Enterovirus PCR Kit</tradeName>
    <deviceName>GeneProof Enterovirus PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040502</emdnCode>
    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV/ISEX/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:40.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161952770</udiDi>
    <basicUdiDi>B-08594161952770</basicUdiDi>
    <tradeName>GeneProof Adenovirus PCR Kit</tradeName>
    <deviceName>GeneProof Adenovirus PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADV/ISEX/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:21.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161952756</udiDi>
    <basicUdiDi>B-08594161952756</basicUdiDi>
    <tradeName>GeneProof Adenovirus PCR Kit</tradeName>
    <deviceName>GeneProof Adenovirus PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADV/ISEX/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:20.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161952572</udiDi>
    <basicUdiDi>B-08594161952572</basicUdiDi>
    <tradeName>GeneProof BK/JC Virus (BK/JC) PCR Kit</tradeName>
    <deviceName>GeneProof BK/JC Virus (BK/JC) PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040523</emdnCode>
    <emdnDescription>JC VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BKJC/ISEX/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:19.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161952558</udiDi>
    <basicUdiDi>B-08594161952558</basicUdiDi>
    <tradeName>GeneProof BK/JC Virus (BK/JC) PCR Kit</tradeName>
    <deviceName>GeneProof BK/JC Virus (BK/JC) PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040523</emdnCode>
    <emdnDescription>JC VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BKJC/ISEX/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:16.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594036043459</udiDi>
    <basicUdiDi>B-08594036043459</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-HHV-6 IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040524</emdnCode>
    <emdnDescription>HHV-6,7,8 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-345</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:45:20.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594036043442</udiDi>
    <basicUdiDi>B-08594036043442</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-HHV-6 IgG (CSF)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040524</emdnCode>
    <emdnDescription>HHV-6,7,8 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-344</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:45:19.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594036042353</udiDi>
    <basicUdiDi>B-08594036042353</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-HHV-6 IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040524</emdnCode>
    <emdnDescription>HHV-6,7,8 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-235</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:43:40.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566762823</udiDi>
    <basicUdiDi>B-08436566762823</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step NGene PCR Fast CE-IVD Tubo 96 Reacciones</tradeName>
    <deviceName>COVID-19 MPX 1-Step NGene PCR Fast CE-IVD Tubo 96 Reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4454</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:09.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566762816</udiDi>
    <basicUdiDi>B-08436566762816</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step NGene PCR Fast-H CE-IVD Placa 96 Reacciones</tradeName>
    <deviceName>COVID-19 MPX 1-Step NGene PCR Fast-H CE-IVD Placa 96 Reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4453</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:08.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566762809</udiDi>
    <basicUdiDi>B-08436566762809</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step NGene PCR Fast-L CE-IVD Placa 96 Reacciones</tradeName>
    <deviceName>COVID-19 MPX 1-Step NGene PCR Fast-L CE-IVD Placa 96 Reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4452</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:06.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566762762</udiDi>
    <basicUdiDi>B-08436566762762</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step NGene PCR Lyo-L CE-IVD. Placa 96 Reacciones.</tradeName>
    <deviceName>COVID-19 MPX 1-Step NGene PCR Lyo-L CE-IVD. Placa 96 Reacciones.</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4429</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:02.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566762755</udiDi>
    <basicUdiDi>B-08436566762755</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step N Gene PCR Lyo. CE-IVD. Tubo 96 Reacciones</tradeName>
    <deviceName>COVID-19 MPX 1-Step N Gene PCR Lyo. CE-IVD. Tubo 96 Reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4427</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:47:00.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566762748</udiDi>
    <basicUdiDi>B-08436566762748</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step NGene PCR Lyo-H CE-IVD. Placa 96 Reacciones.</tradeName>
    <deviceName>COVID-19 MPX 1-Step NGene PCR Lyo-H CE-IVD. Placa 96 Reacciones.</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4428</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:59.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566762731</udiDi>
    <basicUdiDi>B-08436566762731</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step NGene PCR-L CE-IVD. Placa 96 Reacciones.</tradeName>
    <deviceName>COVID-19 MPX 1-Step NGene PCR-L CE-IVD. Placa 96 Reacciones.</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4426</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:58.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566762618</udiDi>
    <basicUdiDi>B-08436566762618</basicUdiDi>
    <tradeName>COVID-19 PCR Fast Lyo -H CE-IVD Placa 96 Reacciones</tradeName>
    <deviceName>COVID-19 PCR Fast Lyo -H CE-IVD Placa 96 Reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4377</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:55.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566762724</udiDi>
    <basicUdiDi>B-08436566762724</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step N Gene PCR H. CE-IVD. Placa 96 reacciones.</tradeName>
    <deviceName>COVID-19 MPX 1-Step N Gene PCR H. CE-IVD. Placa 96 reacciones.</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4425</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:54.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566762717</udiDi>
    <basicUdiDi>B-08436566762717</basicUdiDi>
    <tradeName>COVID-19 MPX 1-Step N Gene PCR. CE-IVD. Tubo 96 Reacciones</tradeName>
    <deviceName>COVID-19 MPX 1-Step N Gene PCR. CE-IVD. Tubo 96 Reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4424</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:53.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566762601</udiDi>
    <basicUdiDi>B-08436566762601</basicUdiDi>
    <tradeName>COVID-19 PCR Fast Lyo -L CE-IVD Placa 96 Reacciones</tradeName>
    <deviceName>COVID-19 PCR Fast Lyo -L CE-IVD Placa 96 Reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4376</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:51.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436566762595</udiDi>
    <basicUdiDi>B-08436566762595</basicUdiDi>
    <tradeName>COVID-19 PCR Fast Lyo CE-IVD Tubo 96 Reacciones</tradeName>
    <deviceName>COVID-19 PCR Fast Lyo CE-IVD Tubo 96 Reacciones</deviceName>
    <manufacturerName>SISTEMAS GENOMICOS. S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000022949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LV4375</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:35.818Z</lastUpdated>
  </row>
</eudamedExport>