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<eudamedExport entity="devices">
  <row>
    <udiDi>+ENTIEIA-41980A</udiDi>
    <basicUdiDi>B-+ENTIEIA-41980A</basicUdiDi>
    <tradeName>+ENTIEIA-41980A</tradeName>
    <deviceName>Herpes Simplex Virus 2 IgG 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>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-4198</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:36.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-419709</udiDi>
    <basicUdiDi>B-+ENTIEIA-419709</basicUdiDi>
    <tradeName>+ENTIEIA-419709</tradeName>
    <deviceName>Herpes Simplex Virus 1 IgM 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>W0105040307</emdnCode>
    <emdnDescription>HSV 1 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-4197</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:35.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-419608</udiDi>
    <basicUdiDi>B-+ENTIEIA-419608</basicUdiDi>
    <tradeName>+ENTIEIA-419608</tradeName>
    <deviceName>Herpes Simplex Virus 1 IgG 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>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-4196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:13:34.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-384003</udiDi>
    <basicUdiDi>B-+ENTIEIA-384003</basicUdiDi>
    <tradeName>+ENTIEIA-384003</tradeName>
    <deviceName>Herpes Simplex Virus 1+2 IgM 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>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3840</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:55.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIEIA-38390B</udiDi>
    <basicUdiDi>B-+ENTIEIA-38390B</basicUdiDi>
    <tradeName>+ENTIEIA-38390B</tradeName>
    <deviceName>Herpes Simplex Virus 1+2 IgG 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>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIA-3839</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:12:51.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIDEHSVM02500%</udiDi>
    <basicUdiDi>B-+ENTIDEHSVM02500%</basicUdiDi>
    <tradeName>+ENTIDEHSVM02500%</tradeName>
    <deviceName>Herpes simplex Virus 1+2 (HSV) IgM 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>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEHSVM0250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:07.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIDEHSVG02500-</udiDi>
    <basicUdiDi>B-+ENTIDEHSVG02500-</basicUdiDi>
    <tradeName>+ENTIDEHSVG02500-</tradeName>
    <deviceName>Herpes simplex Virus 1+2 (HSV) IgG 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>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEHSVG0250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:02.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIDEHSV2M054003</udiDi>
    <basicUdiDi>B-+ENTIDEHSV2M054003</basicUdiDi>
    <tradeName>+ENTIDEHSV2M054003</tradeName>
    <deviceName>Herpes simplex Virus 2 (HSV 2) IgM 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>W0105040310</emdnCode>
    <emdnDescription>HSV 2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEHSV2M0540</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:01.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIDEHSV2G05400/</udiDi>
    <basicUdiDi>B-+ENTIDEHSV2G05400/</basicUdiDi>
    <tradeName>+ENTIDEHSV2G05400/</tradeName>
    <deviceName>Herpes simplex Virus 2 (HSV 2) IgG 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>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEHSV2G0540</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:01.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIDEHSV1M05000+</udiDi>
    <basicUdiDi>B-+ENTIDEHSV1M05000+</basicUdiDi>
    <tradeName>+ENTIDEHSV1M05000+</tradeName>
    <deviceName>Herpes simplex Virus 1 (HSV 1) IgM 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>W0105040307</emdnCode>
    <emdnDescription>HSV 1 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEHSV1M0500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:00.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIDEHSV1G05000Z</udiDi>
    <basicUdiDi>B-+ENTIDEHSV1G05000Z</basicUdiDi>
    <tradeName>+ENTIDEHSV1G05000Z</tradeName>
    <deviceName>Herpes simplex Virus 1 (HSV 1) IgG 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>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEHSV1G0500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:10:56.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID133EU</udiDi>
    <basicUdiDi>B-VID133EU</basicUdiDi>
    <tradeName>VivaDiag Herpes Simplex Virus Type 1 IgG Test Kit (FIA)</tradeName>
    <deviceName>VivaDiag Herpes Simplex Virus Type 1 IgG Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID133-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:39.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST05N6</udiDi>
    <basicUdiDi>B-ST05N6</basicUdiDi>
    <tradeName>Cowingene Herpes Simplex Virus 1/2 Detection Kit</tradeName>
    <deviceName>Cowingene Herpes Simplex Virus 1/2 Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST05011X, ST05012X, ST05013W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:40:29.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JC60202NW-48TU4</udiDi>
    <basicUdiDi>B-JC60202NW-48TU4</basicUdiDi>
    <tradeName>Herpes Simplex Virus Type I/II Real Time PCR Kit</tradeName>
    <deviceName>Herpes Simplex Virus Type I/II Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JC60202NW-48T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:24:16.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JC60202NW-24TTE</udiDi>
    <basicUdiDi>B-JC60202NW-24TTE</basicUdiDi>
    <tradeName>Herpes Simplex Virus Type I/II Real Time PCR Kit</tradeName>
    <deviceName>Herpes Simplex Virus Type I/II Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JC60202NW-24T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:24:16.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISAB-425EM</udiDi>
    <basicUdiDi>B-ISAB-425EM</basicUdiDi>
    <tradeName>HSV 1/2 IgG/IgM Combo Rapid Test Cassette</tradeName>
    <deviceName>HSV 1/2 IgG/IgM 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>W0105040301</emdnCode>
    <emdnDescription>HSV ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISAB-425</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:42:36.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4423125JG</udiDi>
    <basicUdiDi>B-IM4423125JG</basicUdiDi>
    <tradeName>D-IM4423125JG</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>IM4423125</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:29.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4423123JC</udiDi>
    <basicUdiDi>B-IM4423123JC</basicUdiDi>
    <tradeName>D-IM4423123JC</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>IM4423123</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:28.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4422125J9</udiDi>
    <basicUdiDi>B-IM4422125J9</basicUdiDi>
    <tradeName>D-IM4422125J9</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>IM4422125</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:21.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4422123J5</udiDi>
    <basicUdiDi>B-IM4422123J5</basicUdiDi>
    <tradeName>D-IM4422123J5</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>IM4422123</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:35:16.291Z</lastUpdated>
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</eudamedExport>