<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IM4419125KF</udiDi>
    <basicUdiDi>B-IM4419125KF</basicUdiDi>
    <tradeName>D-IM4419125KF</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>IM4419125</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:13.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4418123K4</udiDi>
    <basicUdiDi>B-IM4418123K4</basicUdiDi>
    <tradeName>D-IM4418123K4</tradeName>
    <deviceName>HSV-1 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>W0105040307</emdnCode>
    <emdnDescription>HSV 1 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4418123</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:09.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4419123KB</udiDi>
    <basicUdiDi>B-IM4419123KB</basicUdiDi>
    <tradeName>D-IM4419123KB</tradeName>
    <deviceName>HSV-1 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>W0105040307</emdnCode>
    <emdnDescription>HSV 1 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4419123</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:07.482Z</lastUpdated>
  </row>
  <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-HSV2IgG706-AEED</udiDi>
    <basicUdiDi>B-HSV2IgG706-AEED</basicUdiDi>
    <tradeName>HSV - 1  IgG Herpes Simplex Virus Type 1 IgG Antibody (CLIA)</tradeName>
    <deviceName>HSV - 1  IgG Herpes Simplex Virus Type 1 IgG Antibody (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSV1IgG706-AE10Y, HSV1IgG706-AE10N, HSV1IgG706-AE20Y, HSV1IgG706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:55.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HSV1IgG706-AEDG</udiDi>
    <basicUdiDi>B-HSV1IgG706-AEDG</basicUdiDi>
    <tradeName>HSV - 2 IgG Herpes Simplex Virus Type 2 IgG Antibody (CLIA)</tradeName>
    <deviceName>HSV - 2 IgG Herpes Simplex Virus Type 2 IgG Antibody (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSV2IgG706-AE10Y, HSV2IgG706-AE10N, HSV2IgG706-AE20Y, HSV2IgG706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:57:54.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCHSV(IgM)-402aX7</udiDi>
    <basicUdiDi>B-GCHSV(IgM)-402aX7</basicUdiDi>
    <tradeName>HSV IgM Rapid Test Cassette (Whole blood/Serum/Plasma)</tradeName>
    <deviceName>HSV 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>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHSV(IgM)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:37.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCHSV(IgM)-402aHGGF</udiDi>
    <basicUdiDi>B-GCHSV(IgM)-402aHGGF</basicUdiDi>
    <tradeName>HSV IgM Rapid Test Cassette (Whole blood/Serum/Plasma)</tradeName>
    <deviceName>HSV 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>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHSV(IgM)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:33.112Z</lastUpdated>
  </row>
</eudamedExport>