<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-R179163X</udiDi>
    <basicUdiDi>B-R179163X</basicUdiDi>
    <tradeName>D-R179163X</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17916</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:20.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R179153V</udiDi>
    <basicUdiDi>B-R179153V</basicUdiDi>
    <tradeName>D-R179153V</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17915</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:16.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R179143T</udiDi>
    <basicUdiDi>B-R179143T</basicUdiDi>
    <tradeName>D-R179143T</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17914</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:15.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R179133R</udiDi>
    <basicUdiDi>B-R179133R</basicUdiDi>
    <tradeName>D-R179133R</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17913</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:14.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R179123P</udiDi>
    <basicUdiDi>B-R179123P</basicUdiDi>
    <tradeName>D-R179123P</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17912</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:13.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R179113M</udiDi>
    <basicUdiDi>B-R179113M</basicUdiDi>
    <tradeName>D-R179113M</tradeName>
    <deviceName>Treponema Pallidum Antibody (Anti-TP) 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>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R17911</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:06:09.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873209052</udiDi>
    <basicUdiDi>B-84352873209052</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>VDRL Antigen MR</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2540010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:32:49.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873209045</udiDi>
    <basicUdiDi>B-84352873209045</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>VDRL Antigen MR</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2540005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:32:49.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873209038</udiDi>
    <basicUdiDi>B-84352873209038</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>RPR-Carbon</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2510025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:32:46.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873209021</udiDi>
    <basicUdiDi>B-84352873209021</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>RPR-Carbon</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2510020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:32:45.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873209014</udiDi>
    <basicUdiDi>B-84352873209014</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>RPR-Carbon</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2510015</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:32:40.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873209007</udiDi>
    <basicUdiDi>B-84352873209007</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>RPR-Carbon</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2510010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:32:39.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>18430155003202</udiDi>
    <basicUdiDi>B-18430155003202</basicUdiDi>
    <tradeName>RPR CARBON</tradeName>
    <deviceName>RPR Carbon</deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>992405</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:41:13.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>18430155003073</udiDi>
    <basicUdiDi>B-18430155003073</basicUdiDi>
    <tradeName>RPR CARBON</tradeName>
    <deviceName>RPR Carbon</deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>991400</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:41:13.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>18430155003110</udiDi>
    <basicUdiDi>B-18430155003110</basicUdiDi>
    <tradeName>RPR CARBON</tradeName>
    <deviceName>RPR Carbon</deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>991797</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:41:13.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>B350GSD051600PC0</udiDi>
    <basicUdiDi>++B350GSD051600PCJD</basicUdiDi>
    <tradeName>RPR Reactive Control</tradeName>
    <deviceName>RPR Reactive Control</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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GSD05-1600-PC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:54:13.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>B350GSD051600NC0</udiDi>
    <basicUdiDi>++B350GSD051600NCJ7</basicUdiDi>
    <tradeName>RPR Non-Reactive Control</tradeName>
    <deviceName>RPR Non-Reactive Control</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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GSD05-1600-NC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:54:12.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>B350GSD341600R0</udiDi>
    <basicUdiDi>B-B350GSD341600R0</basicUdiDi>
    <tradeName>Gold Standard Diagnostics RPR Reagent Pack</tradeName>
    <deviceName>Gold Standard Diagnostics RPR Reagent Pack</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>GSD34-1600-R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:42:45.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>B350GSD1600WCASE0</udiDi>
    <basicUdiDi>B-B350GSD1600WCASE0</basicUdiDi>
    <tradeName>Microtiterplates</tradeName>
    <deviceName>Microtiterplates</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>GSD-1600-W-CASE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:42:44.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>B350GSD0116005C0</udiDi>
    <basicUdiDi>B-B350GSD0116005C0</basicUdiDi>
    <tradeName>Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C</tradeName>
    <deviceName>Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C</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>GSD01-1600-5C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:42:43.875Z</lastUpdated>
  </row>
</eudamedExport>