<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07798100043180</udiDi>
    <basicUdiDi>B-07798100043180</basicUdiDi>
    <tradeName>V.D.R.L. test</tradeName>
    <deviceName>V.D.R.L. test</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1853155</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:54.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798100043166</udiDi>
    <basicUdiDi>B-07798100043166</basicUdiDi>
    <tradeName>V.D.R.L. test</tradeName>
    <deviceName>V.D.R.L. test</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1853153</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:53.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798100043159</udiDi>
    <basicUdiDi>B-07798100043159</basicUdiDi>
    <tradeName>V.D.R.L. test</tradeName>
    <deviceName>V.D.R.L. test</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1853152</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:38.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798100043142</udiDi>
    <basicUdiDi>B-07798100043142</basicUdiDi>
    <tradeName>V.D.R.L. test</tradeName>
    <deviceName>V.D.R.L. test</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1853151</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:37.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979878282013</udiDi>
    <basicUdiDi>B-06979878282013</basicUdiDi>
    <tradeName>06979878282013</tradeName>
    <deviceName>Syphilis Antibody Test (Colloidal Gold)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001057</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:51:57.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903341223</udiDi>
    <basicUdiDi>B-06977903341223</basicUdiDi>
    <tradeName>06977903341223</tradeName>
    <deviceName>Syphilis Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110205C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:31.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903341216</udiDi>
    <basicUdiDi>B-06977903341216</basicUdiDi>
    <tradeName>06977903341216</tradeName>
    <deviceName>Syphilis Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110205C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:29.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753477823</udiDi>
    <basicUdiDi>B-06976753477823</basicUdiDi>
    <tradeName>The Anti-Treponema Pallidum(Anti-TP)  Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KC009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:01:30.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753475782</udiDi>
    <basicUdiDi>B-06976753475782</basicUdiDi>
    <tradeName>Syphilis Rapid Test Strip (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010301</emdnCode>
    <emdnDescription>SYPHILIS ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A460501S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:25.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753475751</udiDi>
    <basicUdiDi>B-06976753475751</basicUdiDi>
    <tradeName>Syphilis Rapid Test (serum/plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010301</emdnCode>
    <emdnDescription>SYPHILIS ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A451401D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:25.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753474631</udiDi>
    <basicUdiDi>B-06976753474631</basicUdiDi>
    <tradeName>Syphilis Rapid Test Device (serum/plasma/whole blood)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010301</emdnCode>
    <emdnDescription>SYPHILIS ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A300501D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:12.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984065274</udiDi>
    <basicUdiDi>B-06975984065274</basicUdiDi>
    <tradeName>Syphilis (eCLIA)</tradeName>
    <deviceName>Syphilis (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509812</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:21:55.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984065267</udiDi>
    <basicUdiDi>B-06975984065267</basicUdiDi>
    <tradeName>Syphilis (eCLIA)</tradeName>
    <deviceName>Syphilis (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509811</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:21:54.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984065236</udiDi>
    <basicUdiDi>B-06975984065236</basicUdiDi>
    <tradeName>Syphilis (eCLIA)</tradeName>
    <deviceName>Syphilis (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509807</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:21:38.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984065205</udiDi>
    <basicUdiDi>B-06975984065205</basicUdiDi>
    <tradeName>Syphilis (eCLIA)</tradeName>
    <deviceName>Syphilis (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509808</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:21:33.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>EVIRTVCGRT1</udiDi>
    <basicUdiDi>++EVIRSyphilisIgGABQS</basicUdiDi>
    <tradeName>Treponema + VDRL ViraChip IgG Antigen Coated Wells (8)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010303</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-TVCGRT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:38.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974986814613</udiDi>
    <basicUdiDi>B-06974986814613</basicUdiDi>
    <tradeName>Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:23:57.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974986814606</udiDi>
    <basicUdiDi>B-06974986814606</basicUdiDi>
    <tradeName>Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:23:56.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974986814590</udiDi>
    <basicUdiDi>B-06974986814590</basicUdiDi>
    <tradeName>Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:23:55.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974969982933</udiDi>
    <basicUdiDi>B-06974969982933</basicUdiDi>
    <tradeName>Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay）</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200 Tests/kit（DR1140-3）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:17:18.419Z</lastUpdated>
  </row>
</eudamedExport>