<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GCCHA-302aPH</udiDi>
    <basicUdiDi>B-GCCHA-302aPH</basicUdiDi>
    <tradeName>Chagas Ab Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>Chagas Ab Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCHA-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:18.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCHA-302aHGJ3</udiDi>
    <basicUdiDi>B-GCCHA-302aHGJ3</basicUdiDi>
    <tradeName>Chagas Ab Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>Chagas Ab Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCHA-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:17.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MR172550JR</udiDi>
    <basicUdiDi>B-G2MR172550JR</basicUdiDi>
    <tradeName>RapiT.Cruzi Rapid Antibody Test kit for Trypanosoma cruzi</tradeName>
    <deviceName>RapiT.Cruzi Rapid Antibody Test kit for Trypanosoma cruzi</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>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2MR172550, G2MR170150R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:46:15.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MR172517JT</udiDi>
    <basicUdiDi>B-G2MR172517JT</basicUdiDi>
    <tradeName>RapiMal Rapid Antigen Test kit for Malaria</tradeName>
    <deviceName>RapiMal Rapid Antigen Test kit for Malaria</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>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2MR172517, G2MR170117</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:46:15.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4415117GL</udiDi>
    <basicUdiDi>B-EIM4415117GL</basicUdiDi>
    <tradeName>D-EIM4415117GL</tradeName>
    <deviceName>Chemiluminescent Immunoassay Assay Kits for TOXO IgM</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4415117</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:58:36.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4415116GJ</udiDi>
    <basicUdiDi>B-EIM4415116GJ</basicUdiDi>
    <tradeName>D-EIM4415116GJ</tradeName>
    <deviceName>Chemiluminescent Immunoassay Assay Kits for TOXO IgG</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4415116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:58:35.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4411117FQ</udiDi>
    <basicUdiDi>B-EIM4411117FQ</basicUdiDi>
    <tradeName>D-EIM4411117FQ</tradeName>
    <deviceName>Chemiluminescent Immunoassay Assay Kits for TOXO IgM</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050103</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4411117</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:58:32.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR051GL</udiDi>
    <basicUdiDi>B-CNMF000054349CR051GL</basicUdiDi>
    <tradeName>Malaria Antigen Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Malaria Antigen Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:08:12.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR057GY</udiDi>
    <basicUdiDi>B-CNMF000054349CR057GY</basicUdiDi>
    <tradeName>Malaria pf/pan Rapid Test Kit(Colloidal gold method)</tradeName>
    <deviceName>Malaria pf/pan Rapid Test Kit(Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR057</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:08:12.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR046GT</udiDi>
    <basicUdiDi>B-CNMF000054349CR046GT</basicUdiDi>
    <tradeName>Malaria Antibody Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Malaria Antibody Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR046</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:08:06.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR002G7</udiDi>
    <basicUdiDi>B-CNMF000054349CR002G7</basicUdiDi>
    <tradeName>Malaria pf/pv Antigen Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Malaria pf/pv Antigen Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050209</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:25.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-A292VD</udiDi>
    <basicUdiDi>B-ABT-IDT-A292VD</basicUdiDi>
    <tradeName>Accu-Tell® Entamoeba histolytica  Strip (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-A292</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:11.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-A255V7</udiDi>
    <basicUdiDi>B-ABT-IDT-A255V7</basicUdiDi>
    <tradeName>Accu-Tell® Giardia lamblia Strip (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-A255</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:10.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-A219V3</udiDi>
    <basicUdiDi>B-ABT-IDT-A219V3</basicUdiDi>
    <tradeName>Accu-Tell® Chagas Strip (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-A219</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:04.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A31588UG</udiDi>
    <basicUdiDi>B-A31588UG</basicUdiDi>
    <tradeName>Access Toxo IgG</tradeName>
    <deviceName>Access Toxo IgG</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050102</emdnCode>
    <emdnDescription>TOXOPLASMA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A31588</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:15:53.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313275854</udiDi>
    <basicUdiDi>B-86060313275854</basicUdiDi>
    <tradeName>Cryptosporidium parvum</tradeName>
    <deviceName>Cryptosporidium parvum</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050207</emdnCode>
    <emdnDescription>CRYPTOSPORIDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1804V24CP</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:15:13.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313275786</udiDi>
    <basicUdiDi>B-86060313275786</basicUdiDi>
    <tradeName>Entamoeba histolytica</tradeName>
    <deviceName>Entamoeba histolytica</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050201</emdnCode>
    <emdnDescription>ENTAMOEBA HISTOLYTICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1805V24EH</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:15:12.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313275618</udiDi>
    <basicUdiDi>B-86060313275618</basicUdiDi>
    <tradeName>Giardia</tradeName>
    <deviceName>Giardia</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050208</emdnCode>
    <emdnDescription>GIARDIA LAMBLIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1806V24GIA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:15:07.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277935402G</udiDi>
    <basicUdiDi>B-37700277935402G</basicUdiDi>
    <tradeName>FASCIOLA ES WB IgG</tradeName>
    <deviceName>FASCIOLA ES WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050203</emdnCode>
    <emdnDescription>DISTOMATOSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAS ES-WB96G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:22.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277935332K</udiDi>
    <basicUdiDi>B-37700277935332K</basicUdiDi>
    <tradeName>FASCIOLA ES WB IgG</tradeName>
    <deviceName>FASCIOLA ES WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050203</emdnCode>
    <emdnDescription>DISTOMATOSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAS ES-WB24G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:21.055Z</lastUpdated>
  </row>
</eudamedExport>