<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04099466103925</udiDi>
    <basicUdiDi>B-04099466103925</basicUdiDi>
    <tradeName>04099466103925</tradeName>
    <deviceName>Serazym® Cryptosporidium parvum</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050207</emdnCode>
    <emdnDescription>CRYPTOSPORIDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:38:04.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598013483</udiDi>
    <basicUdiDi>B-04050598013483</basicUdiDi>
    <tradeName>PreventID® Entamoeba histolytica</tradeName>
    <deviceName>PreventID® Entamoeba histolytica</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050201</emdnCode>
    <emdnDescription>ENTAMOEBA HISTOLYTICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KSTIEH602GP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:50:27.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598013476</udiDi>
    <basicUdiDi>B-04050598013476</basicUdiDi>
    <tradeName>PreventID® Entamoeba histolytica</tradeName>
    <deviceName>PreventID® Entamoeba histolytica</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050201</emdnCode>
    <emdnDescription>ENTAMOEBA HISTOLYTICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KSTIEH602G10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:50:23.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325003156</udiDi>
    <basicUdiDi>B-04049325003156</basicUdiDi>
    <tradeName>Chagas (Trypanosoma cruzi) IgG ELISA</tradeName>
    <deviceName>Chagas (Trypanosoma cruzi) IgG ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE58691</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:08:46.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760309513089</udiDi>
    <basicUdiDi>B-03760309513089</basicUdiDi>
    <tradeName>Toda Malariadiag V2</tradeName>
    <deviceName>Toda Malariadiag V2</deviceName>
    <manufacturerName>TODA PHARMA</manufacturerName>
    <manufacturerSrn>FR-MF-000007152</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2272-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:59:04.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532678603711</udiDi>
    <basicUdiDi>B-03532678603711</basicUdiDi>
    <tradeName>PALUTOP +4 OPTIMA</tradeName>
    <deviceName>Palutop +4 Optima</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5499</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:48:06.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517701WX</udiDi>
    <basicUdiDi>B-0320517701WX</basicUdiDi>
    <tradeName>Chagas Controls</tradeName>
    <deviceName>Chagas Controls</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:04.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517604WY</udiDi>
    <basicUdiDi>B-0320517604WY</basicUdiDi>
    <tradeName>Chagas (eCLIA)</tradeName>
    <deviceName>Chagas (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517604</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:02.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517603WW</udiDi>
    <basicUdiDi>B-0320517603WW</basicUdiDi>
    <tradeName>Chagas (eCLIA)</tradeName>
    <deviceName>Chagas (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517603</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:01.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517602WU</udiDi>
    <basicUdiDi>B-0320517602WU</basicUdiDi>
    <tradeName>Chagas (eCLIA)</tradeName>
    <deviceName>Chagas (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:00.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320517601WS</udiDi>
    <basicUdiDi>B-0320517601WS</basicUdiDi>
    <tradeName>Chagas (eCLIA)</tradeName>
    <deviceName>Chagas (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320517601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:33:57.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850078245076</udiDi>
    <basicUdiDi>B-00850078245076</basicUdiDi>
    <tradeName>Fuller Laboratories by VMRD Babesia divergens IFA IgG+IgM Antibody Kit</tradeName>
    <deviceName>Babesia divergens IFA IgG+IgM Antibody Kit</deviceName>
    <manufacturerName>VMRD, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000049394</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DVT-120</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:04:29.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850078245069</udiDi>
    <basicUdiDi>B-00850078245069</basicUdiDi>
    <tradeName>Fuller Laboratories by VMRD Babesia divergens IFA IgM Antibody Kit</tradeName>
    <deviceName>Babesia divergens IFA IgM Antibody Kit</deviceName>
    <manufacturerName>VMRD, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000049394</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DVM-120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:04:28.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850078245052</udiDi>
    <basicUdiDi>B-00850078245052</basicUdiDi>
    <tradeName>Fuller Laboratories by VMRD Babesia divergens IFA IgG Antibody Kit</tradeName>
    <deviceName>Babesia divergens IFA IgG Antibody Kit</deviceName>
    <manufacturerName>VMRD, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000049394</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DVG-120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:04:24.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850078245045</udiDi>
    <basicUdiDi>B-00850078245045</basicUdiDi>
    <tradeName>Fuller Laboratories by VMRD Babesia microti IFA Human IgM Antibody Kit</tradeName>
    <deviceName>Babesia microti IFA Human IgM Antibody Kit</deviceName>
    <manufacturerName>VMRD, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000049394</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMM-120</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:04:23.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850078245038</udiDi>
    <basicUdiDi>B-00850078245038</basicUdiDi>
    <tradeName>Fuller Laboratories by VMRD Babesia microti IFA IgG Antibody Kit</tradeName>
    <deviceName>Babesia microti IFA IgG Antibody Kit</deviceName>
    <manufacturerName>VMRD, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000049394</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMG-120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:04:22.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTITRIG0480DS0A</udiDi>
    <basicUdiDi>B-+ENTITRIG0480DS0A</basicUdiDi>
    <tradeName>+ENTITRIG0480DS0A</tradeName>
    <deviceName>NovaLisa® Trichinella spiralis IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRIG0480DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:08:28.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTITRIG04800C</udiDi>
    <basicUdiDi>B-+ENTITRIG04800C</basicUdiDi>
    <tradeName>+ENTITRIG04800C</tradeName>
    <deviceName>NovaLisa® Trichinella spiralis IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRIG0480</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:08:26.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTITAEG04200S</udiDi>
    <basicUdiDi>B-+ENTITAEG04200S</basicUdiDi>
    <tradeName>+ENTITAEG04200S</tradeName>
    <deviceName>NovaLisa® Taenia solium IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TAEG0420</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:08:12.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTITAEG0420DS0Q</udiDi>
    <basicUdiDi>B-+ENTITAEG0420DS0Q</basicUdiDi>
    <tradeName>+ENTITAEG0420DS0Q</tradeName>
    <deviceName>NovaLisa® Taenia solium IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TAEG0420DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:08:11.261Z</lastUpdated>
  </row>
</eudamedExport>