<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GN7101121GM</udiDi>
    <basicUdiDi>B-GN7101121GM</basicUdiDi>
    <tradeName>D-GN7101121GM</tradeName>
    <deviceName>SARS-CoV-2 Real time Fluorescent PCR Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN7101121</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:42:33.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD156XR</udiDi>
    <basicUdiDi>B-GKPD156XR</basicUdiDi>
    <tradeName>Dengue IgG/IgM Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>Dengue IgG/IgM Detection Kit (Immunofluorescence Chromatography)</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>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD156</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:43.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD152XH</udiDi>
    <basicUdiDi>B-GKPD152XH</basicUdiDi>
    <tradeName>ADV Ag Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>ADV Ag Detection Kit (Immunofluorescence Chromatography)</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>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD152</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:37.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD120X4</udiDi>
    <basicUdiDi>B-GKPD120X4</basicUdiDi>
    <tradeName>Zika Virus IgG/IgM Antibody Rapid Test Kit</tradeName>
    <deviceName>Zika Virus IgG/IgM Antibody 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:37:32.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD119XK</udiDi>
    <basicUdiDi>B-GKPD119XK</basicUdiDi>
    <tradeName>Chikungunya Virus IgG/IgM Antibody and Antigen Combo Rapid Test Kit</tradeName>
    <deviceName>Chikungunya Virus IgG/IgM Antibody and Antigen Combo 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>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD119</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:37:32.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD118XH</udiDi>
    <basicUdiDi>B-GKPD118XH</basicUdiDi>
    <tradeName>Chikungunya Virus IgG/IgM Ab Rapid Test Kit</tradeName>
    <deviceName>Chikungunya Virus IgG/IgM Ab 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>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD118</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:37:31.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD117XF</udiDi>
    <basicUdiDi>B-GKPD117XF</basicUdiDi>
    <tradeName>Chikungunya Virus Ag Rapid Test Kit</tradeName>
    <deviceName>Chikungunya Virus 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>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD117</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:37:27.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCZIK(NS1)-402aHGK4</udiDi>
    <basicUdiDi>B-GCZIK(NS1)-402aHGK4</basicUdiDi>
    <tradeName>Zika NS1 Ag Rapid Test Cassette(Whole blood/Serum/Plasma)</tradeName>
    <deviceName>Zika NS1 Ag 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCZIK(NS1)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:18.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCZIK(NS1)-402aCD</udiDi>
    <basicUdiDi>B-GCZIK(NS1)-402aCD</basicUdiDi>
    <tradeName>Zika NS1 Ag Rapid Test Cassette(Whole blood/Serum/Plasma)</tradeName>
    <deviceName>Zika NS1 Ag 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCZIK(NS1)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:16.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCZIK(IgG/IgM)-T402aHDG</udiDi>
    <basicUdiDi>B-GCZIK(IgG/IgM)-T402aHDG</basicUdiDi>
    <tradeName>Zika IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Zika 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCZIK(IgG/IgM)-T402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:14.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCZIK(IgG/IgM)-T402a3U</udiDi>
    <basicUdiDi>B-GCZIK(IgG/IgM)-T402a3U</basicUdiDi>
    <tradeName>Zika IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Zika 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCZIK(IgG/IgM)-T402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:12.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCZIK(IgG)-402bUW</udiDi>
    <basicUdiDi>B-GCZIK(IgG)-402bUW</basicUdiDi>
    <tradeName>Zika IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Zika IgG 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCZIK(IgG)-402b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:11.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCZIK(IgG)-402bHGB7</udiDi>
    <basicUdiDi>B-GCZIK(IgG)-402bHGB7</basicUdiDi>
    <tradeName>Zika IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Zika IgG 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCZIK(IgG)-402b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:10.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCROA/ADE-602aRF</udiDi>
    <basicUdiDi>B-GCROA/ADE-602aRF</basicUdiDi>
    <tradeName>Rotavirus and Adenovirus Combo Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Rotavirus and Adenovirus Combo 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>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCROA/ADE-602a</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:30:14.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCROA/ADE-602aHGLL</udiDi>
    <basicUdiDi>B-GCROA/ADE-602aHGLL</basicUdiDi>
    <tradeName>Rotavirus and Adenovirus Combo Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Rotavirus and Adenovirus Combo 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>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCROA/ADE-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:30:14.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCROA-602aHG5Z</udiDi>
    <basicUdiDi>B-GCROA-602aHG5Z</basicUdiDi>
    <tradeName>Rotavirus Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Rotavirus 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>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCROA-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:30:13.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCROA-602CaHGBB</udiDi>
    <basicUdiDi>B-GCROA-602CaHGBB</basicUdiDi>
    <tradeName>Rotavirus Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Rotavirus 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>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCROA-602Ca</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:58.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCNOR-602aHGCG</udiDi>
    <basicUdiDi>B-GCNOR-602aHGCG</basicUdiDi>
    <tradeName>Norovirus Antigen Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Norovirus 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>W0105040616</emdnCode>
    <emdnDescription>NOROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCNOR-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:52.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCNOR-602a9E</udiDi>
    <basicUdiDi>B-GCNOR-602a9E</basicUdiDi>
    <tradeName>Norovirus Antigen Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Norovirus 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>W0105040616</emdnCode>
    <emdnDescription>NOROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCNOR-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:51.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCHV(IgM)-402aVU</udiDi>
    <basicUdiDi>B-GCHV(IgM)-402aVU</basicUdiDi>
    <tradeName>Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Hantavirus 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>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHV(IgM)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:43.525Z</lastUpdated>
  </row>
</eudamedExport>