<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06952062773290</udiDi>
    <basicUdiDi>B-06952062773290</basicUdiDi>
    <tradeName>TP Syphilis Antibody Test Kit</tradeName>
    <deviceName>TP Syphilis Antibody Test Kit</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</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>TP1W-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:56:48.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062771944</udiDi>
    <basicUdiDi>B-06952062771944</basicUdiDi>
    <tradeName>TP Syphilis Antibody Test Kit</tradeName>
    <deviceName>TP Syphilis Antibody Test Kit</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</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>TP1W-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:56:17.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062771937</udiDi>
    <basicUdiDi>B-06952062771937</basicUdiDi>
    <tradeName>TP Syphilis Antibody Test Kit</tradeName>
    <deviceName>TP Syphilis Antibody Test Kit</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</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>TP1W-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:56:17.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062771920</udiDi>
    <basicUdiDi>B-06952062771920</basicUdiDi>
    <tradeName>TP Syphilis Antibody Test Kit</tradeName>
    <deviceName>TP Syphilis Antibody Test Kit</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</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>TP2W-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:56:16.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391516745048</udiDi>
    <basicUdiDi>B-05391516745048</basicUdiDi>
    <tradeName>Captia NMT Syphilis IgM EIA</tradeName>
    <deviceName>Captia NMT Syphilis IgM EIA (96 Tests)</deviceName>
    <manufacturerName>Trinity Biotech USA</manufacturerName>
    <manufacturerSrn>US-MF-000037514</manufacturerSrn>
    <authorisedRepresentativeName>TrinityBiotech</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013889</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010304</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2329360</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:47:22.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M52108114LN</udiDi>
    <basicUdiDi>B-++M52108114LN</basicUdiDi>
    <tradeName>EIAgen Syphilis Ab Kit</tradeName>
    <deviceName>EIAgen Syphilis Ab Kit</deviceName>
    <manufacturerName>ADALTIS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000028990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081141 / 081142 / 081145</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:48:33.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810114460900</udiDi>
    <basicUdiDi>081011446R0031CD7</basicUdiDi>
    <tradeName>OnSite® Syphilis Ab Combo Rapid Test</tradeName>
    <deviceName>Syphilis Ab Combo Rapid Test</deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0031C-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:53:47.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414999791</udiDi>
    <basicUdiDi>0405686900730VF</basicUdiDi>
    <tradeName>IMMULITE 2000 Syphilis Screen</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_Syphilis Screen</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>W0105010301</emdnCode>
    <emdnDescription>SYPHILIS ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10489085</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:18:37.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>EVIRTVCMDK1</udiDi>
    <basicUdiDi>++EVIRSyphilisIgMKitDC</basicUdiDi>
    <tradeName>Treponema + VDRL ViraChip IgM Deca Kit</tradeName>
    <deviceName>Treponema + VDRL ViraChip IgM Test Kit</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>W0105010304</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-TVCMDK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:24:23.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>EVIRTVCMAC1</udiDi>
    <basicUdiDi>++EVIRSyphilisIgMABRQ</basicUdiDi>
    <tradeName>Treponema + VDRL ViraChip IgM Antigen Coated Wells</tradeName>
    <deviceName>Treponema + VDRL ViraChip IgM Antigen Coated Wells</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>W0105010304</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-TVCMAC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:24:21.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>EVIRTVCGDK1</udiDi>
    <basicUdiDi>++EVIRSyphilisIgGKitC2</basicUdiDi>
    <tradeName>Treponema + VDRL ViraChip IgG Deca Kit</tradeName>
    <deviceName>Treponema + VDRL ViraChip IgG Test Kit</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-TVCGDK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:24:19.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>EVIRTVCGAC1</udiDi>
    <basicUdiDi>++EVIRSyphilisIgGABQS</basicUdiDi>
    <tradeName>Treponema + VDRL ViraChip IgG Antigen Coated Wells</tradeName>
    <deviceName>Treponema + VDRL ViraChip IgG Antigen Coated Wells</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-TVCGAC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:24:18.780Z</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>D-TD-HNKX-CED-5146</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-5146</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-5146</tradeName>
    <deviceName>Treponema Pallidum Antibody Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</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>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:03.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TP-02100UY</udiDi>
    <basicUdiDi>B-KR-TP-02100UY</basicUdiDi>
    <tradeName>INNODX TP Ab CMIA</tradeName>
    <deviceName>INNODX TP Ab CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TP-01200C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:16.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JB60108NW-50TUT</udiDi>
    <basicUdiDi>B-JB60108NW-50TUT</basicUdiDi>
    <tradeName>Treponema Pallidum Real Time PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010305</emdnCode>
    <emdnDescription>SYPHILIS DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JB60108NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:22:42.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JB60108NW-25TUT</udiDi>
    <basicUdiDi>B-JB60108NW-25TUT</basicUdiDi>
    <tradeName>Treponema Pallidum Real Time PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010305</emdnCode>
    <emdnDescription>SYPHILIS DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JB60108NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:22:41.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD157XT</udiDi>
    <basicUdiDi>B-GKPD157XT</basicUdiDi>
    <tradeName>Treponema pallidum (TP) Antibody Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>Treponema pallidum (TP) Antibody Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD157</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:46.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MR172515JP</udiDi>
    <basicUdiDi>B-G2MR172515JP</basicUdiDi>
    <tradeName>RapiSyph Rapid Antibody Test kit for Syphilis</tradeName>
    <deviceName>RapiSyph Rapid Antibody Test kit for Syphilis</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2MR172515, G2MR170115</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:46:14.285Z</lastUpdated>
  </row>
</eudamedExport>