<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-G2M705921GB</udiDi>
    <basicUdiDi>B-G2M705921GB</basicUdiDi>
    <tradeName>Nipah-Q Real-Time PCR Kit</tradeName>
    <deviceName>Nipah-Q Real-Time PCR Kit</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>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M705921,G2M705921R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:45.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M705421FJ</udiDi>
    <basicUdiDi>B-G2M705421FJ</basicUdiDi>
    <tradeName>BK-Q Real Time PCR Kit for BK virus</tradeName>
    <deviceName>BK-Q Real Time PCR Kit for BK virus</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>W0105040522</emdnCode>
    <emdnDescription>BK VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M705421,G2M705421R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:37.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M705321FD</udiDi>
    <basicUdiDi>B-G2M705321FD</basicUdiDi>
    <tradeName>Chikungunya-Q Real- Time PCR Test Kit</tradeName>
    <deviceName>Chikungunya-Q Real- Time PCR Test Kit</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>W0105040525</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M705321, G2M705321R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:37.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M705021EW</udiDi>
    <basicUdiDi>B-G2M705021EW</basicUdiDi>
    <tradeName>DENGUE-Q Real Time PCR Kit</tradeName>
    <deviceName>DENGUE-Q Real Time PCR Kit</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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M705021, G2M705021R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:32.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M262621F8</udiDi>
    <basicUdiDi>B-G2M262621F8</basicUdiDi>
    <tradeName>ZikaQ Real Time PCR Kit for Zika Virus</tradeName>
    <deviceName>ZikaQ Real Time PCR Kit for Zika Virus</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>W0105040531</emdnCode>
    <emdnDescription>ZIKA VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M262621,G2M262621R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:30.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FE08H6</udiDi>
    <basicUdiDi>B-FE08H6</basicUdiDi>
    <tradeName>Cowingene Dengue Virus Detection Kit</tradeName>
    <deviceName>Cowingene Dengue Virus 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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FE08021X, FE08021X, FE08023W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:23:15.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FE02GS</udiDi>
    <basicUdiDi>B-FE02GS</basicUdiDi>
    <tradeName>Cowingene Dengue Virus I/II/III/IV Detection Kit</tradeName>
    <deviceName>Cowingene Dengue Virus I/II/III/IV 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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FE02021X, FE02022X, FE02023W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:23:11.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EU0100020050EB</udiDi>
    <basicUdiDi>B-EU0100020050EB</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040505</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU0100020050</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:08:21.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EU0100010050DY</udiDi>
    <basicUdiDi>B-EU0100010050DY</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Adenovirus nucleic acid detection and adenovirus 41 identification kit (fluorescent PCR method)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU0100010050</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:08:20.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-027QL</udiDi>
    <basicUdiDi>B-EBX-027QL</basicUdiDi>
    <tradeName>EurobioPlex Parvovirus B19</tradeName>
    <deviceName>EurobioPlex Parvovirus B19</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040509</emdnCode>
    <emdnDescription>PARVOVIRUS B 19 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-027</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:42.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-027-48D9</udiDi>
    <basicUdiDi>B-EBX-027-48D9</basicUdiDi>
    <tradeName>EurobioPlex Parvovirus B19</tradeName>
    <deviceName>EurobioPlex Parvovirus B19</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040509</emdnCode>
    <emdnDescription>PARVOVIRUS B 19 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-027-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:38.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-027-24CT</udiDi>
    <basicUdiDi>B-EBX-027-24CT</basicUdiDi>
    <tradeName>EurobioPlex Parvovirus B19</tradeName>
    <deviceName>EurobioPlex Parvovirus B19</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040509</emdnCode>
    <emdnDescription>PARVOVIRUS B 19 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-027-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:37.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-024QE</udiDi>
    <basicUdiDi>B-EBX-024QE</basicUdiDi>
    <tradeName>EurobioPlex HHV6-HHV8</tradeName>
    <deviceName>EurobioPlex HHV6-HHV8</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</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>EBX-024</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:37.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-024-48CL</udiDi>
    <basicUdiDi>B-EBX-024-48CL</basicUdiDi>
    <tradeName>EurobioPlex HHV6-HHV8</tradeName>
    <deviceName>EurobioPlex HHV6-HHV8</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</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>EBX-024-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:36.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-024-24C6</udiDi>
    <basicUdiDi>B-EBX-024-24C6</basicUdiDi>
    <tradeName>EurobioPlex HHV6-HHV8</tradeName>
    <deviceName>EurobioPlex HHV6-HHV8</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</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>EBX-024-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:32.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-018QK</udiDi>
    <basicUdiDi>B-EBX-018QK</basicUdiDi>
    <tradeName>EurobioPlex Dengue 1234</tradeName>
    <deviceName>EurobioPlex Dengue 1234</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-018</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:25.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-018-48D5</udiDi>
    <basicUdiDi>B-EBX-018-48D5</basicUdiDi>
    <tradeName>EurobioPlex Dengue 1234</tradeName>
    <deviceName>EurobioPlex Dengue 1234</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-018-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:24.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-018-24CP</udiDi>
    <basicUdiDi>B-EBX-018-24CP</basicUdiDi>
    <tradeName>EurobioPlex Dengue 1234</tradeName>
    <deviceName>EurobioPlex Dengue 1234</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-018-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:23.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-016QF</udiDi>
    <basicUdiDi>B-EBX-016QF</basicUdiDi>
    <tradeName>EurobioPlex JC Virus</tradeName>
    <deviceName>EurobioPlex JC Virus</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</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>EBX-016</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:16.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-016-48CP</udiDi>
    <basicUdiDi>B-EBX-016-48CP</basicUdiDi>
    <tradeName>EurobioPlex JC Virus</tradeName>
    <deviceName>EurobioPlex JC Virus</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</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>EBX-016-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:12.992Z</lastUpdated>
  </row>
</eudamedExport>