<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>++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>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-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>
  <row>
    <udiDi>D-EIM4205323FL</udiDi>
    <basicUdiDi>B-EIM4205323FL</basicUdiDi>
    <tradeName>D-EIM4205323FL</tradeName>
    <deviceName>Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>EIM4205323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:53:05.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4202323EX</udiDi>
    <basicUdiDi>B-EIM4202323EX</basicUdiDi>
    <tradeName>D-EIM4202323EX</tradeName>
    <deviceName>Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>EIM4202323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:48:32.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4201323EQ</udiDi>
    <basicUdiDi>B-EIM4201323EQ</basicUdiDi>
    <tradeName>D-EIM4201323EQ</tradeName>
    <deviceName>Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>EIM4201323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:48:20.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR003G9</udiDi>
    <basicUdiDi>B-CNMF000054349CR003G9</basicUdiDi>
    <tradeName>Syphilis (TP) Antibody Rapid Test Kit</tradeName>
    <deviceName>Syphilis (TP) Antibody Rapid Test Kit</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>CR003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:27.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Anti-TP706-AECQ</udiDi>
    <basicUdiDi>B-Anti-TP706-AECQ</basicUdiDi>
    <tradeName>Anti-TP Treponema Pallidum Antibody (CLIA)</tradeName>
    <deviceName>Anti-TP Treponema Pallidum Antibody (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Anti-TP706-AE10Y, Anti-TP706-AE10N, Anti-TP706-AE20Y, Anti-TP706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:46:28.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7N02F5</udiDi>
    <basicUdiDi>B-7N02F5</basicUdiDi>
    <tradeName>Treponema Pallidum Antibody assay (CLIA)</tradeName>
    <deviceName>Treponema Pallidum Antibody assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</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>7N02V1-B-EU, 7N02U1-B-EU, 7N02P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:29:11.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719014</udiDi>
    <basicUdiDi>692591270114GZ</basicUdiDi>
    <tradeName>iFlash-Anti-TP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:13.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912721598</udiDi>
    <basicUdiDi>692591270114GZ</basicUdiDi>
    <tradeName>iFlash-Anti-TP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88049-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698601429</udiDi>
    <basicUdiDi>B-16972698601429</basicUdiDi>
    <tradeName>Treponema Pallidum Antibody Rapid Test</tradeName>
    <deviceName>Treponema Pallidum Antibody Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</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>P231111</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:25.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>08887581001051</udiDi>
    <basicUdiDi>B-08887581001051</basicUdiDi>
    <tradeName>MP Diagnostics TP ELISA 4.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MP Biomedicals Asia Pacific Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024819</manufacturerSrn>
    <authorisedRepresentativeName>MP Biomedicals Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000020992</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23560-096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:22:42.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>08887581001068</udiDi>
    <basicUdiDi>B-08887581001068</basicUdiDi>
    <tradeName>MP Diagnostics TP ELISA 4.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MP Biomedicals Asia Pacific Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024819</manufacturerSrn>
    <authorisedRepresentativeName>MP Biomedicals Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000020992</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23560-480</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:22:40.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385505502EH</udiDi>
    <basicUdiDi>B-084360385505502EH</basicUdiDi>
    <tradeName>TPHA, 200 tests</tradeName>
    <deviceName>TPHA, 200 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>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0177</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:15.050Z</lastUpdated>
  </row>
</eudamedExport>