<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GKPD137XM</udiDi>
    <basicUdiDi>B-GKPD137XM</basicUdiDi>
    <tradeName>Trichomonas vaginalis Ag Rapid Test Kit</tradeName>
    <deviceName>Trichomonas vaginalis Ag Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050210</emdnCode>
    <emdnDescription>TRICHOMONAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD137</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:14.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCTV-502aHG3D</udiDi>
    <basicUdiDi>B-GCTV-502aHG3D</basicUdiDi>
    <tradeName>Trichomonas Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Trichomonas Ag Rapid Test Cassette (Swab)</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>W0105050210</emdnCode>
    <emdnDescription>TRICHOMONAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCTV-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:32:41.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCTV-502a9Z</udiDi>
    <basicUdiDi>B-GCTV-502a9Z</basicUdiDi>
    <tradeName>Trichomonas Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Trichomonas Ag Rapid Test Cassette (Swab)</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>W0105050210</emdnCode>
    <emdnDescription>TRICHOMONAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCTV-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:32:40.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCKal-T402aYL</udiDi>
    <basicUdiDi>B-GCKal-T402aYL</basicUdiDi>
    <tradeName>Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/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>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-T402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:51.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCKal-T402aHGQK</udiDi>
    <basicUdiDi>B-GCKal-T402aHGQK</basicUdiDi>
    <tradeName>Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leishmania IgG/IgM 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>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-T402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:50.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCKal-402aNM</udiDi>
    <basicUdiDi>B-GCKal-402aNM</basicUdiDi>
    <tradeName>Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leishmania Ab Rapid Test Cassette (Whole Blood/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>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:49.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCKal-402aHGWR</udiDi>
    <basicUdiDi>B-GCKal-402aHGWR</basicUdiDi>
    <tradeName>Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leishmania 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>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:45.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCKal-401aNJ</udiDi>
    <basicUdiDi>B-GCKal-401aNJ</basicUdiDi>
    <tradeName>Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leishmania Ab Rapid Test Strip (Whole Blood/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>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-401a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:45.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCKal-401aHGWJ</udiDi>
    <basicUdiDi>B-GCKal-401aHGWJ</basicUdiDi>
    <tradeName>Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leishmania Ab Rapid Test Strip (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>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-401a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:44.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCGIA-602aT3</udiDi>
    <basicUdiDi>B-GCGIA-602aT3</basicUdiDi>
    <tradeName>Giardia lamblia Antigen Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Giardia lamblia Antigen Rapid Test Cassette (Feces)</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>W0105050208</emdnCode>
    <emdnDescription>GIARDIA LAMBLIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCGIA-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:27:17.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCGIA-602aHGPM</udiDi>
    <basicUdiDi>B-GCGIA-602aHGPM</basicUdiDi>
    <tradeName>Giardia lamblia Antigen Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Giardia lamblia Antigen Rapid Test Cassette (Feces)</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>W0105050208</emdnCode>
    <emdnDescription>GIARDIA LAMBLIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCGIA-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:27:16.748Z</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-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-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>
</eudamedExport>