<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>B350GSD0116000</udiDi>
    <basicUdiDi>B-B350GSD0116000</basicUdiDi>
    <tradeName>Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System</tradeName>
    <deviceName>Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System</deviceName>
    <manufacturerName>Gold Standard Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000027142</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GSD01-1600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:42:38.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360386346344FZ</udiDi>
    <basicUdiDi>B-084360386346344FZ</basicUdiDi>
    <tradeName>RPR Carbon, 1 x 5 mL</tradeName>
    <deviceName>RPR Carbon, 1 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0431</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:30:57.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360386336337FR</udiDi>
    <basicUdiDi>B-084360386336337FR</basicUdiDi>
    <tradeName>RPR Carbon, 250 tests</tradeName>
    <deviceName>RPR Carbon, 250 tests</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0426</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:30:53.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360386196197H9</udiDi>
    <basicUdiDi>B-084360386196197H9</basicUdiDi>
    <tradeName>VDRL, 250 tests</tradeName>
    <deviceName>VDRL, 250 tests</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0382</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:30:34.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385675677JF</udiDi>
    <basicUdiDi>B-084360385675677JF</basicUdiDi>
    <tradeName>RPR Carbon, 500 tests</tradeName>
    <deviceName>RPR Carbon, 500 tests</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0220</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:30.247Z</lastUpdated>
  </row>
  <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>05060515140122</udiDi>
    <basicUdiDi>506051514RPREF</basicUdiDi>
    <tradeName>Newbio RPR 100</tradeName>
    <deviceName>Newbio RPR</deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:22:54.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891328412</udiDi>
    <basicUdiDi>803389132RPRD-A00YC</basicUdiDi>
    <tradeName>RPR-DAT ADVANCED</tradeName>
    <deviceName>RPR-DAT ADVANCED</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26031</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:43:34.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140306</udiDi>
    <basicUdiDi>506051514RPREF</basicUdiDi>
    <tradeName>Newbio RPR 500</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:23.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140290</udiDi>
    <basicUdiDi>506051514RPREF</basicUdiDi>
    <tradeName>Newbio RPR 100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:22.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140139</udiDi>
    <basicUdiDi>506051514RPREF</basicUdiDi>
    <tradeName>Newbio RPR 500</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:18.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140047</udiDi>
    <basicUdiDi>B-05060515140047</basicUdiDi>
    <tradeName>PK7400 TP HA Controls</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B11187</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:10.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658559947</udiDi>
    <basicUdiDi>B-04260658559947</basicUdiDi>
    <tradeName>Atlas RPR Carbon Antigen Reagent, 5 ml/Vial, 1 Vial/Box.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.18.2.0005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:36:09.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658557455</udiDi>
    <basicUdiDi>B-04260658557455</basicUdiDi>
    <tradeName>RPR Carbon Antigen Kit, 100 Tests (2 ml Reagent, 2x0.5 ml Controls, White Glass slide, Stirring sticks).</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.18.2.0100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:35:59.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658551248</udiDi>
    <basicUdiDi>B-04260658551248</basicUdiDi>
    <tradeName>Atlas VDRL Kit , 2500 Tests</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.20.0.2500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:15.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658551224</udiDi>
    <basicUdiDi>B-04260658551224</basicUdiDi>
    <tradeName>Atlas TPHA Kit, 200 Tests</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.19.0.0200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:14.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658551194</udiDi>
    <basicUdiDi>B-04260658551194</basicUdiDi>
    <tradeName>Atlas RPR Carbon Antigen Kit, 100 Tests</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.18.0.0100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:13.746Z</lastUpdated>
  </row>
</eudamedExport>