<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IM4418125K8</udiDi>
    <basicUdiDi>B-IM4418125K8</basicUdiDi>
    <tradeName>D-IM4418125K8</tradeName>
    <deviceName>HSV-2 IgM Antibody Chemiluminescent Immunoassay 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>W0105040310</emdnCode>
    <emdnDescription>HSV 2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4418125</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:06.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4415126JM</udiDi>
    <basicUdiDi>B-IM4415126JM</basicUdiDi>
    <tradeName>D-IM4415126JM</tradeName>
    <deviceName>HSV-1/2 IgM Antibody Chemiluminescent Immunoassay 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>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4415126</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:34:22.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4415124JH</udiDi>
    <basicUdiDi>B-IM4415124JH</basicUdiDi>
    <tradeName>D-IM4415124JH</tradeName>
    <deviceName>HSV-2 IgG Antibody Chemiluminescent Immunoassay 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>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4415124</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:34:21.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4415122JD</udiDi>
    <basicUdiDi>B-IM4415122JD</basicUdiDi>
    <tradeName>D-IM4415122JD</tradeName>
    <deviceName>HSV-1 IgG Antibody Chemiluminescent Immunoassay 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>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4415122</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:34:17.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4414126JE</udiDi>
    <basicUdiDi>B-IM4414126JE</basicUdiDi>
    <tradeName>D-IM4414126JE</tradeName>
    <deviceName>HSV-1/2 IgM Antibody Chemiluminescent Immunoassay 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>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4414126</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:33:32.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4414124JA</udiDi>
    <basicUdiDi>B-IM4414124JA</basicUdiDi>
    <tradeName>D-IM4414124JA</tradeName>
    <deviceName>HSV-2 IgG Antibody Chemiluminescent Immunoassay 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>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4414124</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:33:32.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4414122J6</udiDi>
    <basicUdiDi>B-IM4414122J6</basicUdiDi>
    <tradeName>D-IM4414122J6</tradeName>
    <deviceName>HSV-1 IgG Antibody Chemiluminescent Immunoassay 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>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4414122</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:33:31.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4411126HR</udiDi>
    <basicUdiDi>B-IM4411126HR</basicUdiDi>
    <tradeName>D-IM4411126HR</tradeName>
    <deviceName>HSV-1/2 IgM Antibody Chemiluminescent Immunoassay 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>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4411126</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:32:41.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4411124HM</udiDi>
    <basicUdiDi>B-IM4411124HM</basicUdiDi>
    <tradeName>D-IM4411124HM</tradeName>
    <deviceName>HSV-2 IgG Antibody Chemiluminescent Immunoassay 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>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4411124</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:32:40.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4411122HH</udiDi>
    <basicUdiDi>B-IM4411122HH</basicUdiDi>
    <tradeName>D-IM4411122HH</tradeName>
    <deviceName>HSV-1 IgG Antibody Chemiluminescent Immunoassay 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>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4411122</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:32:40.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4410126HJ</udiDi>
    <basicUdiDi>B-IM4410126HJ</basicUdiDi>
    <tradeName>D-IM4410126HJ</tradeName>
    <deviceName>HSV-1/2 IgM Antibody Chemiluminescent Immunoassay 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>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4410126</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:32:07.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4410124HE</udiDi>
    <basicUdiDi>B-IM4410124HE</basicUdiDi>
    <tradeName>D-IM4410124HE</tradeName>
    <deviceName>HSV-2 IgG Antibody Chemiluminescent Immunoassay 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>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4410124</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:32:07.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4410122HA</udiDi>
    <basicUdiDi>B-IM4410122HA</basicUdiDi>
    <tradeName>D-IM4410122HA</tradeName>
    <deviceName>HSV-1 IgG Antibody Chemiluminescent Immunoassay 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>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4410122</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:30:37.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHVGM-402G6</udiDi>
    <basicUdiDi>B-IHVGM-402G6</basicUdiDi>
    <tradeName>Hantavirus lgG/lgM Rapid Test Cassette</tradeName>
    <deviceName>Hantavirus lgG/lgM 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>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHVGM-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:46.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHMPV-R502LB</udiDi>
    <basicUdiDi>B-IHMPV-R502LB</basicUdiDi>
    <tradeName>HMPV Rapid Test</tradeName>
    <deviceName>HMPV Rapid Test</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>W0105040617</emdnCode>
    <emdnDescription>HUMAN METAPNEUMOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHMPV-R502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:40.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFA-R5028H</udiDi>
    <basicUdiDi>B-IFA-R5028H</basicUdiDi>
    <tradeName>H1N1 Antigen Rapid Test Cassette</tradeName>
    <deviceName>H1N1 Antigen 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>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFA-R502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:14.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IENG-R4027C</udiDi>
    <basicUdiDi>B-IENG-R4027C</basicUdiDi>
    <tradeName>EBNA IgG Rapid Test Cassette</tradeName>
    <deviceName>EBNA IgG 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>W010504040106</emdnCode>
    <emdnDescription>EBV EBNA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IENG-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:13.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IECNG-R4255A</udiDi>
    <basicUdiDi>B-IECNG-R4255A</basicUdiDi>
    <tradeName>EBV VCA and EBNA IgG Combo Rapid Test Cassette</tradeName>
    <deviceName>EBV VCA and EBNA IgG 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>W010504040199</emdnCode>
    <emdnDescription>EBV ANTIBODIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IECNG-R425</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:05:34.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IECG-R402ZE</udiDi>
    <basicUdiDi>B-IECG-R402ZE</basicUdiDi>
    <tradeName>EBV VCA IgG Rapid Test Cassette</tradeName>
    <deviceName>EBV VCA IgG 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>W010504040105</emdnCode>
    <emdnDescription>EBV VCA IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IECG-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:05:33.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICSG-R4028T</udiDi>
    <basicUdiDi>B-ICSG-R4028T</basicUdiDi>
    <tradeName>SARS-CoV-2 S-RBD IgG Antibody Rapid Test</tradeName>
    <deviceName>SARS-CoV-2 S-RBD IgG Antibody Rapid Test</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>W0105041103</emdnCode>
    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICSG-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:05:14.737Z</lastUpdated>
  </row>
</eudamedExport>