<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-COMBIPACKLB</udiDi>
    <basicUdiDi>B-COMBIPACKLB</basicUdiDi>
    <tradeName>D-COMBIPACKLB</tradeName>
    <deviceName>Ovulation and Pregnancy Test Combi Pack</deviceName>
    <manufacturerName>Sanavita Pharmaceuticals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COMBIPACK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:09:53.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349YS006Q8</udiDi>
    <basicUdiDi>B-CNMF000054349YS006Q8</basicUdiDi>
    <tradeName>SP 10 Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>SP 10 Rapid Test Kit (Colloidal gold method)</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>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YS006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:09:33.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349YS003Q2</udiDi>
    <basicUdiDi>B-CNMF000054349YS003Q2</basicUdiDi>
    <tradeName>FSH Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>FSH Rapid Test Kit (Colloidal gold method)</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>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YS003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:09:32.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349YS001PW</udiDi>
    <basicUdiDi>B-CNMF000054349YS001PW</basicUdiDi>
    <tradeName>LH Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>LH Rapid Test Kit (Colloidal gold method)</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>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YS001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:09:28.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNM0000180726003N4</udiDi>
    <basicUdiDi>B-CNM0000180726003N4</basicUdiDi>
    <tradeName>D-CNM0000180726003N4</tradeName>
    <deviceName>One-Step FSH Menopause Test</deviceName>
    <manufacturerName>Shanghai Chemtron Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018072</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003C  6003S  6003D 6003B</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:10:24.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNM0000180726002N2</udiDi>
    <basicUdiDi>B-CNM0000180726002N2</basicUdiDi>
    <tradeName>D-CNM0000180726002N2</tradeName>
    <deviceName>One-Step LH Ovulation Test</deviceName>
    <manufacturerName>Shanghai Chemtron Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018072</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6002S 6002C 6002D</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:10:24.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNM0000180726001MY</udiDi>
    <basicUdiDi>B-CNM0000180726001MY</basicUdiDi>
    <tradeName>D-CNM0000180726001MY</tradeName>
    <deviceName>One-Step HCG Pregnancy Test</deviceName>
    <manufacturerName>Shanghai Chemtron Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018072</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6001C  6001S  6001D 6001B</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:10:23.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AMH-D06a9L</udiDi>
    <basicUdiDi>B-AMH-D06a9L</basicUdiDi>
    <tradeName>AMH Test Kit FIA</tradeName>
    <deviceName>AMH Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMH-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:35:21.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACK21003-S07-016DT</udiDi>
    <basicUdiDi>B-ACK21003-S07-016DT</basicUdiDi>
    <tradeName>Dr. Max Ovulation Test</tradeName>
    <deviceName>LH Ovulation Tests</deviceName>
    <manufacturerName>Core Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023522</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACK21003-S07-016</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:15.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACK21001-S02-018AS</udiDi>
    <basicUdiDi>B-ACK21001-S02-018AS</basicUdiDi>
    <tradeName>Dr. Max Pregnancy Test 2in1</tradeName>
    <deviceName>HCG Pregnancy Tests</deviceName>
    <manufacturerName>Core Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023522</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACK21001-S02-018</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:13.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACK21001-M01-01879</udiDi>
    <basicUdiDi>B-ACK21001-M01-01879</basicUdiDi>
    <tradeName>Dr. Max Pregnancy Test Comfort</tradeName>
    <deviceName>HCG Pregnancy Tests</deviceName>
    <manufacturerName>Core Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023522</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACK21001-M01-018</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:11.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACK21001-C01-018ZU</udiDi>
    <basicUdiDi>B-ACK21001-C01-018ZU</basicUdiDi>
    <tradeName>Dr. Max Pregnancy Test</tradeName>
    <deviceName>HCG Pregnancy Tests</deviceName>
    <manufacturerName>Core Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023522</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACK21001-C01-018</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:09.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-C123</udiDi>
    <basicUdiDi>B-ABT-FT-C123</basicUdiDi>
    <tradeName>One Step HCG Pregnancy Test</tradeName>
    <deviceName>One Step HCG Pregnancy Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-C1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:58.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-C387PM</udiDi>
    <basicUdiDi>B-ABT-FT-C387PM</basicUdiDi>
    <tradeName>Accu-Tell® HCG Multi-Line Midstream (Urine)</tradeName>
    <deviceName>Accu-Tell® HCG Multi-Line Midstream (Urine)</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-C387</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:56.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-C327</udiDi>
    <basicUdiDi>B-ABT-FT-C327</basicUdiDi>
    <tradeName>One Step LH Ovulation Test</tradeName>
    <deviceName>One Step LH Ovulation Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-C3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:56.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-B324</udiDi>
    <basicUdiDi>B-ABT-FT-B324</basicUdiDi>
    <tradeName>One Step LH Ovulation Test</tradeName>
    <deviceName>One Step LH Ovulation Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-B3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:39.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-B1ZV</udiDi>
    <basicUdiDi>B-ABT-FT-B1ZV</basicUdiDi>
    <tradeName>One Step HCG Pregnancy Test</tradeName>
    <deviceName>One Step HCG Pregnancy Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-B1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:38.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-A3ZW</udiDi>
    <basicUdiDi>B-ABT-FT-A3ZW</basicUdiDi>
    <tradeName>One Step LH Ovulation Test</tradeName>
    <deviceName>One Step LH Ovulation Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-A3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:37.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-A387P7</udiDi>
    <basicUdiDi>B-ABT-FT-A387P7</basicUdiDi>
    <tradeName>Accu-Tell® HCG Multi-Line Strip (Urine)</tradeName>
    <deviceName>Accu-Tell® HCG Multi-Line Strip (Urine)</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-A387</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:36.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-FT-A1ZS</udiDi>
    <basicUdiDi>B-ABT-FT-A1ZS</basicUdiDi>
    <tradeName>One Step HCG Pregnancy Test</tradeName>
    <deviceName>One Step HCG Pregnancy Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FT-A1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:25:32.724Z</lastUpdated>
  </row>
</eudamedExport>