<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ISGMA-402D2</udiDi>
    <basicUdiDi>B-ISGMA-402D2</basicUdiDi>
    <tradeName>HSV 1 IgG/IgM Rapid Test Cassette</tradeName>
    <deviceName>HSV 1 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>W0105040305</emdnCode>
    <emdnDescription>HSV 1 ANTIBODIES - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISGMA-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:30:25.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISGM-425LU</udiDi>
    <basicUdiDi>B-ISGM-425LU</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>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040302</emdnCode>
    <emdnDescription>HSV 1+2 ANTIBODIES - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISGM-425</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:30:23.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISGM-402LG</udiDi>
    <basicUdiDi>B-ISGM-402LG</basicUdiDi>
    <tradeName>HSV 1/2 IgG/IgM Rapid Test Cassette</tradeName>
    <deviceName>HSV 1/2 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>W0105040302</emdnCode>
    <emdnDescription>HSV 1+2 ANTIBODIES - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISGM-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:30:21.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISGM-325LP</udiDi>
    <basicUdiDi>B-ISGM-325LP</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>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040302</emdnCode>
    <emdnDescription>HSV 1+2 ANTIBODIES - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISGM-325</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:30:20.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISGM-302LB</udiDi>
    <basicUdiDi>B-ISGM-302LB</basicUdiDi>
    <tradeName>HSV 1/2 IgG/IgM Rapid Test Cassette</tradeName>
    <deviceName>HSV 1/2 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>W0105040302</emdnCode>
    <emdnDescription>HSV 1+2 ANTIBODIES - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISGM-302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:30:19.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISG-402TW</udiDi>
    <basicUdiDi>B-ISG-402TW</basicUdiDi>
    <tradeName>HSV 1/2 IgG Rapid Test Cassette</tradeName>
    <deviceName>HSV 1/2 IgG 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>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISG-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:30:16.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISG-302TR</udiDi>
    <basicUdiDi>B-ISG-302TR</basicUdiDi>
    <tradeName>HSV 1/2 IgG Rapid Test Cassette</tradeName>
    <deviceName>HSV 1/2 IgG 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>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISG-302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:30:15.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768022784</udiDi>
    <basicUdiDi>0405686901815VX</basicUdiDi>
    <tradeName>Atellica IM Herpes-1 IgG (HSV1)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_HSV1</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10733031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:49:32.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768022807</udiDi>
    <basicUdiDi>0405686901816VZ</basicUdiDi>
    <tradeName>Atellica IM Herpes-2 IgG (HSV2)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_HSV2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10733033</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:52:24.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414999784</udiDi>
    <basicUdiDi>0405686901454VM</basicUdiDi>
    <tradeName>IMMULITE 2000 Herpes I &amp; II IgG</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_Herpes I &amp; II IgG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381333</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:41:09.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414016740</udiDi>
    <basicUdiDi>0405686901815VX</basicUdiDi>
    <tradeName>ADVIA Centaur Herpes-1 IgG (HSV1)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_HSV1</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040306</emdnCode>
    <emdnDescription>HSV 1 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10720846</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:10.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414016726</udiDi>
    <basicUdiDi>0405686901816VZ</basicUdiDi>
    <tradeName>ADVIA Centaur Herpes-2 IgG (HSV2)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_HSV2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040309</emdnCode>
    <emdnDescription>HSV 2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10720849</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:08.100Z</lastUpdated>
  </row>
  <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>
  </row>
  <row>
    <udiDi>D-ISGM-R425ER</udiDi>
    <basicUdiDi>B-ISGM-R425ER</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>W0105040302</emdnCode>
    <emdnDescription>HSV 1+2 ANTIBODIES - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISGM-R425</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:04:16.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISGM-R402ED</udiDi>
    <basicUdiDi>B-ISGM-R402ED</basicUdiDi>
    <tradeName>HSV 1/2 IgG/IgM Rapid Test Cassette</tradeName>
    <deviceName>HSV 1/2 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>W0105040302</emdnCode>
    <emdnDescription>HSV 1+2 ANTIBODIES - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISGM-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:04:13.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISG-R402HP</udiDi>
    <basicUdiDi>B-ISG-R402HP</basicUdiDi>
    <tradeName>HSV 1/2 IgG Rapid Test Cassette</tradeName>
    <deviceName>HSV 1/2 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>W0105040303</emdnCode>
    <emdnDescription>HSV 1+2 IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISG-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:04:12.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130A0209EYSK5U</udiDi>
    <basicUdiDi>B-697603130A0209EYSK5U</basicUdiDi>
    <tradeName>D-697603130A0209EYSK5U</tradeName>
    <deviceName>Herpes Simplex VirusⅠDetection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101A0209EY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:49.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130A0216EYSB4N</udiDi>
    <basicUdiDi>B-697603130A0216EYSB4N</basicUdiDi>
    <tradeName>D-697603130A0216EYSB4N</tradeName>
    <deviceName>Herpes Simplex VirusⅡDetection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101A0216EY ，101A0216EYD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:43.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840310634</udiDi>
    <basicUdiDi>B-69743840310634</basicUdiDi>
    <tradeName>HSV IgG/IgM Rapid Test</tradeName>
    <deviceName>HSV IgG/IgM 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>W0105040305</emdnCode>
    <emdnDescription>HSV 1 ANTIBODIES - TOTAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3022901</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:23.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960AHSV201WCJG</udiDi>
    <basicUdiDi>B-69509960AHSV201WCJG</basicUdiDi>
    <tradeName>D-69509960AHSV201WCJG</tradeName>
    <deviceName>Herpes Simplex VirusⅡDetection Kit (Fluorescence PCR)</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>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHSV201-AOG48E; AHSV201-AOG96E; AHSV201D-AOG48E; AHSV201D-AOG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:49.940Z</lastUpdated>
  </row>
</eudamedExport>