<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08436040328415</udiDi>
    <basicUdiDi>843604032RTPCR00401VK</basicUdiDi>
    <tradeName>ZIKV/DENV/CHIKV REALTIME PCR KIT</tradeName>
    <deviceName>ZIKV/DENV/CHIKV REALTIME PCR KIT</deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTPCR004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:49:28.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815381021007</udiDi>
    <basicUdiDi>357302BUDI002231TD</basicUdiDi>
    <tradeName>BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel</tradeName>
    <deviceName>BIOFIRE® FILMARRAY® Tropical Fever (TF) 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>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>424803</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:23.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684190150459</udiDi>
    <basicUdiDi>B-08684190150459</basicUdiDi>
    <tradeName>Tropical Fever Detection and Monitoring Kit (24)</tradeName>
    <deviceName>Tropical Fever Detection and Monitoring Kit (24)</deviceName>
    <manufacturerName>ANT BIYOTEKNOLOJI SANAYI VE TICARET ANONIM SIRKETI</manufacturerName>
    <manufacturerSrn>TR-MF-000052831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4150241</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-20T00:57:39.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M801521F8</udiDi>
    <basicUdiDi>B-G2M801521F8</basicUdiDi>
    <tradeName>Para2-Q Real Time PCR Kit</tradeName>
    <deviceName>Para2-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>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M801521,G2M801521R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:44:38.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M706121FA</udiDi>
    <basicUdiDi>B-G2M706121FA</basicUdiDi>
    <tradeName>Para-Q Multiplex Real Time PCR kit</tradeName>
    <deviceName>Para-Q Multiplex 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>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M706121,G2M706121R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:49.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FE01GQ</udiDi>
    <basicUdiDi>B-FE01GQ</basicUdiDi>
    <tradeName>Cowingene Dengue Virus, Zika Virus and Chikungunya Virus Detection Kit</tradeName>
    <deviceName>Cowingene Dengue Virus, Zika Virus and Chikungunya 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>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FE01021X, FE01022X, FE01023W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:23:11.192Z</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>08800056355008</udiDi>
    <basicUdiDi>B-08800056355008</basicUdiDi>
    <tradeName>PowerChek™ ZIKV / DENV / CHIKV Multiplex Real-time PCR Kit</tradeName>
    <deviceName>PowerChek™ ZIKV / DENV / CHIKV Multiplex Real-time PCR Kit</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R5504</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:38.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436040328712</udiDi>
    <basicUdiDi>843604032RTPCR00401VK</basicUdiDi>
    <tradeName>ZIKV/DENV/CHIKV REALTIME PCR KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTPCR004-LP</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:49:05.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215565</udiDi>
    <basicUdiDi>B-08684387215565</basicUdiDi>
    <tradeName>RevoDx African Swine Fever Virus qPCR Kit</tradeName>
    <deviceName>RevoDx African Swine Fever Virus qPCR 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>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202226-500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:05:35.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215558</udiDi>
    <basicUdiDi>B-08684387215558</basicUdiDi>
    <tradeName>RevoDx African Swine Fever Virus qPCR Kit</tradeName>
    <deviceName>RevoDx African Swine Fever Virus qPCR 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>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P202226-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:05:34.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215404</udiDi>
    <basicUdiDi>B-08684387215404</basicUdiDi>
    <tradeName>RevoDx Dengue / Zika / Chikungunya Virus qPCR Kit</tradeName>
    <deviceName>RevoDx Dengue / Zika / Chikungunya Virus qPCR 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>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202523-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:04:52.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215398</udiDi>
    <basicUdiDi>B-08684387215398</basicUdiDi>
    <tradeName>RevoDx Dengue / Zika / Chikungunya Virus qPCR Kit</tradeName>
    <deviceName>RevoDx Dengue / Zika / Chikungunya Virus qPCR 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>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202523-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:04:51.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975447582041</udiDi>
    <basicUdiDi>B-06975447582041</basicUdiDi>
    <tradeName>06975447582041</tradeName>
    <deviceName>Dengue virus/Chikungunya virus/Zika virus Diagnostic Kit (PCR-Fluorescence)</deviceName>
    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001552</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106-0044-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:00.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974795550535</udiDi>
    <basicUdiDi>B-06974795550535</basicUdiDi>
    <tradeName>06974795550535</tradeName>
    <deviceName>Dengue virus &amp; Zika virus &amp; Chikungunya virus &amp; Hantavirus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10200162B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:46:14.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974795550528</udiDi>
    <basicUdiDi>B-06974795550528</basicUdiDi>
    <tradeName>06974795550528</tradeName>
    <deviceName>Dengue virus &amp; Zika virus &amp; Chikungunya virus &amp; Hantavirus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10200162A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:46:13.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323011484</udiDi>
    <basicUdiDi>B-06974323011484</basicUdiDi>
    <tradeName>06974323011484</tradeName>
    <deviceName>Triplex Real-time PCR Detection Kit for Yellow Fever/Zika/Chikungunya</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID059</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:47:22.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323011477</udiDi>
    <basicUdiDi>B-06974323011477</basicUdiDi>
    <tradeName>06974323011477</tradeName>
    <deviceName>Triplex Real-time PCR Detection Kit for Yellow Fever/Zika/Chikungunya</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID059</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:47:22.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323010463</udiDi>
    <basicUdiDi>B-06974323010463</basicUdiDi>
    <tradeName>06974323010463</tradeName>
    <deviceName>Quadruplex Real-time PCR Detection Kit for Dengue / Marburg / Rift Valley Fever / Lassa</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A5994</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:43:10.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323010456</udiDi>
    <basicUdiDi>B-06974323010456</basicUdiDi>
    <tradeName>06974323010456</tradeName>
    <deviceName>Quadruplex Real-time PCR Detection Kit for Dengue / Marburg / Rift Valley Fever / Lassa</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A5994</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:43:08.617Z</lastUpdated>
  </row>
</eudamedExport>