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<eudamedExport entity="devices">
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    <udiDi>08436040326343</udiDi>
    <basicUdiDi>843604032VCM03601CQ</basicUdiDi>
    <tradeName>HERPES SIMPLEX 1+2 VIRCLIA® IgM 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>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCM036</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:48:49.713Z</lastUpdated>
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  <row>
    <udiDi>06903053039512</udiDi>
    <basicUdiDi>69449040AB74000145F</basicUdiDi>
    <tradeName>Herpes Simplex Virus 1+2 IgM（CLIA）</tradeName>
    <deviceName>Herpes Simplex Virus 1+2 IgM（CLIA）</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012489-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:49:13.829Z</lastUpdated>
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  <row>
    <udiDi>D-R187163U</udiDi>
    <basicUdiDi>B-R187163U</basicUdiDi>
    <tradeName>D-R187163U</tradeName>
    <deviceName>Herpes Simplex Virus type 1/2 Antibody IgM (HSV1/2 IgM) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R18716</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:30.660Z</lastUpdated>
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  <row>
    <udiDi>D-R187153S</udiDi>
    <basicUdiDi>B-R187153S</basicUdiDi>
    <tradeName>D-R187153S</tradeName>
    <deviceName>Herpes Simplex Virus type 1/2 Antibody IgM (HSV1/2 IgM) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R18715</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:29.488Z</lastUpdated>
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    <udiDi>D-R187143Q</udiDi>
    <basicUdiDi>B-R187143Q</basicUdiDi>
    <tradeName>D-R187143Q</tradeName>
    <deviceName>Herpes Simplex Virus type 1/2 Antibody IgM (HSV1/2 IgM) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R18714</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:28.684Z</lastUpdated>
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  <row>
    <udiDi>D-R187133N</udiDi>
    <basicUdiDi>B-R187133N</basicUdiDi>
    <tradeName>D-R187133N</tradeName>
    <deviceName>Herpes Simplex Virus type 1/2 Antibody IgM (HSV1/2 IgM) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R18713</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:23.890Z</lastUpdated>
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  <row>
    <udiDi>D-R187123L</udiDi>
    <basicUdiDi>B-R187123L</basicUdiDi>
    <tradeName>D-R187123L</tradeName>
    <deviceName>Herpes Simplex Virus type 1/2 Antibody IgM (HSV1/2 IgM) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R18712</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:23.076Z</lastUpdated>
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  <row>
    <udiDi>D-R187113J</udiDi>
    <basicUdiDi>B-R187113J</basicUdiDi>
    <tradeName>D-R187113J</tradeName>
    <deviceName>Herpes Simplex Virus type 1/2 Antibody IgM (HSV1/2 IgM) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R18711</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:22.827Z</lastUpdated>
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  <row>
    <udiDi>D-ISM-402VY</udiDi>
    <basicUdiDi>B-ISM-402VY</basicUdiDi>
    <tradeName>HSV 1/2 IgM Rapid Test Cassette</tradeName>
    <deviceName>HSV 1/2 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>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISM-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:30:27.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISM-302VT</udiDi>
    <basicUdiDi>B-ISM-302VT</basicUdiDi>
    <tradeName>HSV 1/2 IgM Rapid Test Cassette</tradeName>
    <deviceName>HSV 1/2 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>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISM-302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:30:27.109Z</lastUpdated>
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  <row>
    <udiDi>D-ISM-R402L5</udiDi>
    <basicUdiDi>B-ISM-R402L5</basicUdiDi>
    <tradeName>HSV 1/2 IgM Rapid Test Cassette</tradeName>
    <deviceName>HSV 1/2 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>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISM-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:04:22.450Z</lastUpdated>
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    <udiDi>+ENTIRE579510L</udiDi>
    <basicUdiDi>B-+ENTIRE579510L</basicUdiDi>
    <tradeName>+ENTIRE579510L</tradeName>
    <deviceName>Herpes simplex Virus 1+2 (HSV) IgM</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>RE57951</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:18:59.745Z</lastUpdated>
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    <udiDi>+ENTIHSVM0250DS0D</udiDi>
    <basicUdiDi>B-+ENTIHSVM0250DS0D</basicUdiDi>
    <tradeName>+ENTIHSVM0250DS0D</tradeName>
    <deviceName>NovaLisa® Herpes simplex Virus 1+2 (HSV) IgM</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>HSVM0250DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:14:46.249Z</lastUpdated>
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    <udiDi>+ENTIHSVM02500F</udiDi>
    <basicUdiDi>B-+ENTIHSVM02500F</basicUdiDi>
    <tradeName>+ENTIHSVM02500F</tradeName>
    <deviceName>NovaLisa® Herpes simplex Virus 1+2 (HSV) IgM</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>HSVM0250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:14:45.441Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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