<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ICHA-40289</udiDi>
    <basicUdiDi>B-ICHA-40289</basicUdiDi>
    <tradeName>Chagas Rapid Test Cassette</tradeName>
    <deviceName>Chagas Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICHA-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:37:03.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICHA-30284</udiDi>
    <basicUdiDi>B-ICHA-30284</basicUdiDi>
    <tradeName>Chagas Rapid Test Cassette</tradeName>
    <deviceName>Chagas Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICHA-302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:37:03.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIRE586910N</udiDi>
    <basicUdiDi>B-+ENTIRE586910N</basicUdiDi>
    <tradeName>+ENTIRE586910N</tradeName>
    <deviceName>Chagas (Trypanosoma cruzi) 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>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE58691</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:19:12.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-581305</udiDi>
    <basicUdiDi>B-+ENTIEIA-581305</basicUdiDi>
    <tradeName>+ENTIEIA-581305</tradeName>
    <deviceName>Chagas (Trypanosoma cruzi) IgG ELISA</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>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-5813</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:47.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIDENO01140X</udiDi>
    <basicUdiDi>B-+ENTIDENO01140X</basicUdiDi>
    <tradeName>+ENTIDENO01140X</tradeName>
    <deviceName>Chagas (Trypanosoma cruzi) IgG ELISA</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>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DENO0114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:32.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTICHAG0560DS0H</udiDi>
    <basicUdiDi>B-+ENTICHAG0560DS0H</basicUdiDi>
    <tradeName>+ENTICHAG0560DS0H</tradeName>
    <deviceName>NovaLisa® Chagas (Trypanosoma cruzi) 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>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHAG0560DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:09:50.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTICHAG05600J</udiDi>
    <basicUdiDi>B-+ENTICHAG05600J</basicUdiDi>
    <tradeName>+ENTICHAG05600J</tradeName>
    <deviceName>NovaLisa® Chagas (Trypanosoma cruzi) 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>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHAG0560</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:09:49.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICHA-R402YF</udiDi>
    <basicUdiDi>B-ICHA-R402YF</basicUdiDi>
    <tradeName>Chagas Rapid Test Cassette</tradeName>
    <deviceName>Chagas Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICHA-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:04:49.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICHA-R302YA</udiDi>
    <basicUdiDi>B-ICHA-R302YA</basicUdiDi>
    <tradeName>Chagas Rapid Test Cassette</tradeName>
    <deviceName>Chagas Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICHA-R302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:04:48.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCHA-402aPQ</udiDi>
    <basicUdiDi>B-GCCHA-402aPQ</basicUdiDi>
    <tradeName>Chagas Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Chagas Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</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>GCCHA-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:23.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCHA-402aHGJG</udiDi>
    <basicUdiDi>B-GCCHA-402aHGJG</basicUdiDi>
    <tradeName>Chagas Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Chagas Ab Rapid Test Cassette (Whole Blood/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-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:19.558Z</lastUpdated>
  </row>
  <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-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-37700277931822C</udiDi>
    <basicUdiDi>B-37700277931822C</basicUdiDi>
    <tradeName>CHAGAS WB IgG</tradeName>
    <deviceName>CHAGAS WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-WB96G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:56:10.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277931752F</udiDi>
    <basicUdiDi>B-37700277931752F</basicUdiDi>
    <tradeName>CHAGAS WB IgG</tradeName>
    <deviceName>CHAGAS WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-WB24G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:56:06.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277931682J</udiDi>
    <basicUdiDi>B-37700277931682J</basicUdiDi>
    <tradeName>CHAGAS WB IgG</tradeName>
    <deviceName>CHAGAS WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-WB12G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:56:05.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798100046839</udiDi>
    <basicUdiDi>B-07798100046839</basicUdiDi>
    <tradeName>Chagatest ELISA lisado</tradeName>
    <deviceName>Chagatest ELISA lisado</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1293096</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:20.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798100047720</udiDi>
    <basicUdiDi>B-07798100047720</basicUdiDi>
    <tradeName>Chagatest ELISA recombinante v.4.0</tradeName>
    <deviceName>Chagatest ELISA recombinante v.4.0</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050202</emdnCode>
    <emdnDescription>CHAGAS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1293258</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:20.155Z</lastUpdated>
  </row>
</eudamedExport>