<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04049095210099</udiDi>
    <basicUdiDi>4049095UN17250000SF</basicUdiDi>
    <tradeName>04049095210099</tradeName>
    <deviceName>RIDA®UNITY Parasitic Stool Panel II</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UN1725</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:52:42.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095030086</udiDi>
    <basicUdiDi>4049095C170100000KM</basicUdiDi>
    <tradeName>04049095030086</tradeName>
    <deviceName>RIDASCREEN® Entamoeba</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050201</emdnCode>
    <emdnDescription>ENTAMOEBA HISTOLYTICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:50:01.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095030055</udiDi>
    <basicUdiDi>4049095C120100000GN</basicUdiDi>
    <tradeName>04049095030055</tradeName>
    <deviceName>RIDASCREEN® Cryptosporidium</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050207</emdnCode>
    <emdnDescription>CRYPTOSPORIDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:49:58.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095030048</udiDi>
    <basicUdiDi>4049095C110100000G3</basicUdiDi>
    <tradeName>04049095030048</tradeName>
    <deviceName>RIDASCREEN® Giardia</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050208</emdnCode>
    <emdnDescription>GIARDIA LAMBLIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:49:44.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>03661540100680</udiDi>
    <basicUdiDi>3661540PARhemag017C</basicUdiDi>
    <tradeName>E.L.I.H.A TOXO</tradeName>
    <deviceName>E.L.I.H.A TOXO</deviceName>
    <manufacturerName>ELITECH MICROBIO</manufacturerName>
    <manufacturerSrn>FR-MF-000025235</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050101</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66610</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T10:23:02.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>03661540100666</udiDi>
    <basicUdiDi>3661540PARhemag027E</basicUdiDi>
    <tradeName>ELI.H.A Echinococcus</tradeName>
    <deviceName>ELI.H.A Echinococcus</deviceName>
    <manufacturerName>ELITECH MICROBIO</manufacturerName>
    <manufacturerSrn>FR-MF-000025235</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050204</emdnCode>
    <emdnDescription>ECHINOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66604</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T10:22:59.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026634902</udiDi>
    <basicUdiDi>357302BUDI002209TL</basicUdiDi>
    <tradeName>VIDAS® TOXO IgM</tradeName>
    <deviceName>VIDAS® TOXO IgM</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>424641</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:44:36.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532678607740</udiDi>
    <basicUdiDi>353267F00191P8Q</basicUdiDi>
    <tradeName>BIOSYNEX AMPLIFLASH MALARIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050309</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150053</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:27:01.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532678604220</udiDi>
    <basicUdiDi>353267F00094P8S</basicUdiDi>
    <tradeName>BIOSYNEX AMPLIQUICK Malaria</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050309</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3120019_SEC01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:26:38.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301699</udiDi>
    <basicUdiDi>859569630026QK</basicUdiDi>
    <tradeName>GeneProof Trichomonas vaginalis PCR Kit</tradeName>
    <deviceName>GeneProof Trichomonas vaginalis PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050310</emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:59:10.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301682</udiDi>
    <basicUdiDi>859569630026QK</basicUdiDi>
    <tradeName>GeneProof Trichomonas vaginalis PCR Kit</tradeName>
    <deviceName>GeneProof Trichomonas vaginalis PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050310</emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:59:08.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973864382985</udiDi>
    <basicUdiDi>6973864380046EU</basicUdiDi>
    <tradeName>LiCA Toxo lgG</tradeName>
    <deviceName>LiCA Toxo IgG</deviceName>
    <manufacturerName>Chemclin Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009729</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05010828321</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:19.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973864382671</udiDi>
    <basicUdiDi>6973864380046EU</basicUdiDi>
    <tradeName>LiCA Toxo lgG</tradeName>
    <deviceName>LiCA Toxo IgG</deviceName>
    <manufacturerName>Chemclin Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009729</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05010828342</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:18.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973864382664</udiDi>
    <basicUdiDi>6973864380046EU</basicUdiDi>
    <tradeName>LiCA Toxo lgG</tradeName>
    <deviceName>LiCA Toxo IgG</deviceName>
    <manufacturerName>Chemclin Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009729</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05010828332</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:17.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973864382657</udiDi>
    <basicUdiDi>6973864380046EU</basicUdiDi>
    <tradeName>LiCA Toxo lgG</tradeName>
    <deviceName>LiCA Toxo IgG</deviceName>
    <manufacturerName>Chemclin Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009729</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05010828322</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:09:11.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581432245</udiDi>
    <basicUdiDi>B-06970581432245</basicUdiDi>
    <tradeName>Accu-Tell® Giardia lamblia Cassette (Feces)</tradeName>
    <deviceName>Accu-Tell® Giardia lamblia Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050208</emdnCode>
    <emdnDescription>GIARDIA LAMBLIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B255</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:24.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581432238</udiDi>
    <basicUdiDi>B-06970581432238</basicUdiDi>
    <tradeName>Accu-Tell® Entamoeba Histolytica Cassette (Feces)</tradeName>
    <deviceName>Accu-Tell® Entamoeba histolytica Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050201</emdnCode>
    <emdnDescription>ENTAMOEBA HISTOLYTICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B292</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:23.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581432221</udiDi>
    <basicUdiDi>B-06970581432221</basicUdiDi>
    <tradeName>Accu-Tell® Chagas Cassette(Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® Chagas Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B219</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:22.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150908850</udiDi>
    <basicUdiDi>697015090000104GV</basicUdiDi>
    <tradeName>Toxo IgG CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMK0602</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:48:19.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970150908805</udiDi>
    <basicUdiDi>697015090000099HV</basicUdiDi>
    <tradeName>Toxo IgM CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMK0102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:48:09.969Z</lastUpdated>
  </row>
</eudamedExport>