<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>08684595030165</udiDi>
    <basicUdiDi>B-08684595030165</basicUdiDi>
    <tradeName>RapidFor™ Zika IgG/IgM Rapid Test Kit (FIA)</tradeName>
    <deviceName>Zika IgG/IgM Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO76</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:12:57.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683347941490</udiDi>
    <basicUdiDi>B-08683347941490</basicUdiDi>
    <tradeName>RapidFor™ Zika IgM Rapid Test Kit</tradeName>
    <deviceName>Zika IgM Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD43</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:04:45.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050616041081</udiDi>
    <basicUdiDi>B-08050616041081</basicUdiDi>
    <tradeName>ZIKV IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000029123</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZIKVM.CE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:10:24.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202763392</udiDi>
    <basicUdiDi>B-06976202763392</basicUdiDi>
    <tradeName>Zika NS1 Rapid Test</tradeName>
    <deviceName>Zika NS1 Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIZNS1-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:40:04.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202763385</udiDi>
    <basicUdiDi>B-06976202763385</basicUdiDi>
    <tradeName>Zika IgG/IgM Rapid Test</tradeName>
    <deviceName>Zika IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIZGM-422</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:40:01.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202763378</udiDi>
    <basicUdiDi>B-06976202763378</basicUdiDi>
    <tradeName>Zika IgG/IgM/NS1 Combo Rapid Test</tradeName>
    <deviceName>Zika IgG/IgM/NS1 Combo Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIZGMN-432</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:40:00.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302769</udiDi>
    <basicUdiDi>B-06974566302769</basicUdiDi>
    <tradeName>Zika IgG/IgM Rapid Test</tradeName>
    <deviceName>Zika IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</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>IZK-4221</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:53:14.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302752</udiDi>
    <basicUdiDi>B-06974566302752</basicUdiDi>
    <tradeName>Zika IgG/IgM Rapid Test</tradeName>
    <deviceName>Zika IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</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>IZK-42225</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:53:12.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323019992</udiDi>
    <basicUdiDi>B-06974323019992</basicUdiDi>
    <tradeName>06974323019992</tradeName>
    <deviceName>Zika Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:07:16.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323018735</udiDi>
    <basicUdiDi>B-06974323018735</basicUdiDi>
    <tradeName>06974323018735</tradeName>
    <deviceName>Zika Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:03:06.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323018728</udiDi>
    <basicUdiDi>B-06974323018728</basicUdiDi>
    <tradeName>06974323018728</tradeName>
    <deviceName>Zika Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:03:05.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974238910247</udiDi>
    <basicUdiDi>B-06974238910247</basicUdiDi>
    <tradeName>Zika Virus IgG/IgM And NS1 Combo Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</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>HZIK010GT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:58:14.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974238910230</udiDi>
    <basicUdiDi>B-06974238910230</basicUdiDi>
    <tradeName>Zika virus NS1 Antigen Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</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>HDEN006G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:58:10.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974238910223</udiDi>
    <basicUdiDi>B-06974238910223</basicUdiDi>
    <tradeName>Zika virus IgG/IgM Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</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>:HZIK009T</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:58:09.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804827892</udiDi>
    <basicUdiDi>B-06952804827892</basicUdiDi>
    <tradeName>06952804827892</tradeName>
    <deviceName>Zika IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZIKA-W23M</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:33:01.016Z</lastUpdated>
  </row>
</eudamedExport>