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<eudamedExport entity="devices">
  <row>
    <udiDi>++B379ZKM217Q</udiDi>
    <basicUdiDi>B-++B379ZKM217Q</basicUdiDi>
    <tradeName>++B379ZKM217Q</tradeName>
    <deviceName>ZIKV Detect™ 2.0 IgM Capture ELISA</deviceName>
    <manufacturerName>InBios International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020625</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZKM2-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:27.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436040326732</udiDi>
    <basicUdiDi>843604032VCM03301C9</basicUdiDi>
    <tradeName>ZIKA VIRCLIA® IgG MONOTEST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCM033</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:48:52.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IZIG-402NX</udiDi>
    <basicUdiDi>B-IZIG-402NX</basicUdiDi>
    <tradeName>Zika NS1 Rapid Test Cassette</tradeName>
    <deviceName>Zika NS1 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IZIG-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:58.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IZIC-425MX</udiDi>
    <basicUdiDi>B-IZIC-425MX</basicUdiDi>
    <tradeName>Zika IgG/IgM and NS1 Combo Rapid Test Cassette</tradeName>
    <deviceName>Zika IgG/IgM and NS1 Combo 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IZIC-425</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:57.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IZIB-402M8</udiDi>
    <basicUdiDi>B-IZIB-402M8</basicUdiDi>
    <tradeName>Zika IgG/IgM Rapid Test Cassette</tradeName>
    <deviceName>Zika IgG/IgM 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IZIB-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:57.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FI-ZIM-4022K</udiDi>
    <basicUdiDi>B-FI-ZIM-4022K</basicUdiDi>
    <tradeName>Zika IgM Test Cassette</tradeName>
    <deviceName>Zika IgM 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-ZIM-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:39.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FI-ZI-402XL</udiDi>
    <basicUdiDi>B-FI-ZI-402XL</basicUdiDi>
    <tradeName>Zika antigen Test Cassette</tradeName>
    <deviceName>Zika antigen 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-ZI-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:37.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IZIG-R402H6</udiDi>
    <basicUdiDi>B-IZIG-R402H6</basicUdiDi>
    <tradeName>Zika NS1 Rapid Test Cassette</tradeName>
    <deviceName>Zika NS1 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IZIG-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:07:13.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IZIC-R425FW</udiDi>
    <basicUdiDi>B-IZIC-R425FW</basicUdiDi>
    <tradeName>Zika IgG/IgM and NS1 Combo Rapid Test Cassette</tradeName>
    <deviceName>Zika IgG/IgM and NS1 Combo 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IZIC-R425</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:07:06.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IZIB-R402F5</udiDi>
    <basicUdiDi>B-IZIB-R402F5</basicUdiDi>
    <tradeName>Zika IgG/IgM Rapid Test Cassette</tradeName>
    <deviceName>Zika IgG/IgM 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IZIB-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:07:04.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840311242</udiDi>
    <basicUdiDi>B-69743840311242</basicUdiDi>
    <tradeName>Zika Rapid Test</tradeName>
    <deviceName>Zika Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</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>Artık piyasada değil</deviceStatus>
    <reference>3023903</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:36.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIZVM0790DS0C</udiDi>
    <basicUdiDi>B-+ENTIZVM0790DS0C</basicUdiDi>
    <tradeName>+ENTIZVM0790DS0C</tradeName>
    <deviceName>NovaLisa® Zika Virus IgM μ-capture</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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZVM0790DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:20:54.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIZVM07900E</udiDi>
    <basicUdiDi>B-+ENTIZVM07900E</basicUdiDi>
    <tradeName>+ENTIZVM07900E</tradeName>
    <deviceName>NovaLisa® Zika Virus IgM μ-capture</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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZVM0790</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:20:27.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIZVG0790DS06</udiDi>
    <basicUdiDi>B-+ENTIZVG0790DS06</basicUdiDi>
    <tradeName>+ENTIZVG0790DS06</tradeName>
    <deviceName>NovaLisa® Zika Virus IgG capture</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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZVG0790DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:20:24.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIZVG079008</udiDi>
    <basicUdiDi>B-+ENTIZVG079008</basicUdiDi>
    <tradeName>+ENTIZVG079008</tradeName>
    <deviceName>NovaLisa® Zika Virus IgG capture</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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZVG0790</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:20:23.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-59840E</udiDi>
    <basicUdiDi>B-+ENTIEIA-59840E</basicUdiDi>
    <tradeName>+ENTIEIA-59840E</tradeName>
    <deviceName>Zika Virus IgG capture 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-5984</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:54.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-59080A</udiDi>
    <basicUdiDi>B-+ENTIEIA-59080A</basicUdiDi>
    <tradeName>+ENTIEIA-59080A</tradeName>
    <deviceName>Zika Virus IgM μ-capture 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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-5908</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:48.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI301134410D</udiDi>
    <basicUdiDi>B-+ENTI301134410D</basicUdiDi>
    <tradeName>+ENTI301134410D</tradeName>
    <deviceName>Zika Virus IgM μ-capture</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>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113441</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:05.348Z</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-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>
</eudamedExport>