<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>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>
  <row>
    <udiDi>D-37700277935262N</udiDi>
    <basicUdiDi>B-37700277935262N</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-WB12G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:20.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277935192R</udiDi>
    <basicUdiDi>B-37700277935192R</basicUdiDi>
    <tradeName>SCHISTO II WB IgG</tradeName>
    <deviceName>SCHISTO II WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050206</emdnCode>
    <emdnDescription>SCHISTOSOMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCH-WB96G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:19.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-377002779350228</udiDi>
    <basicUdiDi>B-377002779350228</basicUdiDi>
    <tradeName>SCHISTO II WB IgG</tradeName>
    <deviceName>SCHISTO II WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050206</emdnCode>
    <emdnDescription>SCHISTOSOMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCH-WB24G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:18.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-377002779349636</udiDi>
    <basicUdiDi>B-377002779349636</basicUdiDi>
    <tradeName>SCHISTO II WB IgG</tradeName>
    <deviceName>SCHISTO II WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050206</emdnCode>
    <emdnDescription>SCHISTOSOMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCH-WB12G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:14.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-377002779348939</udiDi>
    <basicUdiDi>B-377002779348939</basicUdiDi>
    <tradeName>TRICHINELLA ES WB IgG</tradeName>
    <deviceName>TRICHINELLA 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>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRI ES-WB96G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:13.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277934722Q</udiDi>
    <basicUdiDi>B-37700277934722Q</basicUdiDi>
    <tradeName>TRICHINELLA ES WB IgG</tradeName>
    <deviceName>TRICHINELLA 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>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRI ES-WB24G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:12.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277934652T</udiDi>
    <basicUdiDi>B-37700277934652T</basicUdiDi>
    <tradeName>TRICHINELLA ES WB IgG</tradeName>
    <deviceName>TRICHINELLA 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>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRI ES-WB12G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:09.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277934582W</udiDi>
    <basicUdiDi>B-37700277934582W</basicUdiDi>
    <tradeName>ECHINOCOCCUS WB IgG</tradeName>
    <deviceName>ECHINOCOCCUS WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050204</emdnCode>
    <emdnDescription>ECHINOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH-WB96G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:08.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277934412D</udiDi>
    <basicUdiDi>B-37700277934412D</basicUdiDi>
    <tradeName>ECHINOCOCCUS WB IgG</tradeName>
    <deviceName>ECHINOCOCCUS WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050204</emdnCode>
    <emdnDescription>ECHINOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH-WB24G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:07.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277934342G</udiDi>
    <basicUdiDi>B-37700277934342G</basicUdiDi>
    <tradeName>ECHINOCOCCUS WB IgG</tradeName>
    <deviceName>ECHINOCOCCUS WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050204</emdnCode>
    <emdnDescription>ECHINOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH-WB12G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:05.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-37700277934272K</udiDi>
    <basicUdiDi>B-37700277934272K</basicUdiDi>
    <tradeName>LEISHMANIA WB IgG</tradeName>
    <deviceName>LEISHMANIA WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LES-WB96G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:03.431Z</lastUpdated>
  </row>
</eudamedExport>