<?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-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>86979834610139</udiDi>
    <basicUdiDi>B-86979834610139</basicUdiDi>
    <tradeName>HCG Test Kit(Urine)</tradeName>
    <deviceName>HCG Test Kit(Urine)</deviceName>
    <manufacturerName>Neo-nostics (Suzhou) Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013087</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCG0034</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:22:10.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-823150PW</udiDi>
    <basicUdiDi>B-823150PW</basicUdiDi>
    <tradeName>safe &amp; easy</tradeName>
    <deviceName>Ovulationstest</deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>823150-5</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:07:58.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-821050PB</udiDi>
    <basicUdiDi>B-821050PB</basicUdiDi>
    <tradeName>Securtest Test di Ovulazione</tradeName>
    <deviceName>Test di Ovulazione</deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</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>821050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:07:14.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-820008P5</udiDi>
    <basicUdiDi>B-820008P5</basicUdiDi>
    <tradeName>FertiQUICK</tradeName>
    <deviceName>FertiQUICK [BG/EN]</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</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>820008</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:06:13.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-820007P3</udiDi>
    <basicUdiDi>B-820007P3</basicUdiDi>
    <tradeName>FertiQUICK</tradeName>
    <deviceName>FertiQUICK [HU/EN/RO/PL]</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</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>820007</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:06:13.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-820005NX</udiDi>
    <basicUdiDi>B-820005NX</basicUdiDi>
    <tradeName>FertiQUICK</tradeName>
    <deviceName>FertiQUICK  [DE/EN/FR/NL]</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</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>820005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:06:12.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-820003NT</udiDi>
    <basicUdiDi>B-820003NT</basicUdiDi>
    <tradeName>FertiQUICK</tradeName>
    <deviceName>FertiQUICK  [SLO/HR]</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</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>820003</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:06:11.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-820002NR</udiDi>
    <basicUdiDi>B-820002NR</basicUdiDi>
    <tradeName>ZuhauseTEST Fertilität</tradeName>
    <deviceName>ZuhauseTEST Fertilität</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</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>820002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:06:07.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-820001NP</udiDi>
    <basicUdiDi>B-820001NP</basicUdiDi>
    <tradeName>D-820001NP</tradeName>
    <deviceName>FertiQUICK (DE/EN)</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</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>820001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:06:06.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-811043P3</udiDi>
    <basicUdiDi>B-811043P3</basicUdiDi>
    <tradeName>D-811043P3</tradeName>
    <deviceName>SHBG  Rapid Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:57:29.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-811022NT</udiDi>
    <basicUdiDi>B-811022NT</basicUdiDi>
    <tradeName>D-811022NT</tradeName>
    <deviceName>AMH Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:57:07.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-811021NR</udiDi>
    <basicUdiDi>B-811021NR</basicUdiDi>
    <tradeName>D-811021NR</tradeName>
    <deviceName>PRL Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:57:06.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808185QW</udiDi>
    <basicUdiDi>B-808185QW</basicUdiDi>
    <tradeName>D-808185QW</tradeName>
    <deviceName>TESTO Rapid Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808185</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:34.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808183QS</udiDi>
    <basicUdiDi>B-808183QS</basicUdiDi>
    <tradeName>D-808183QS</tradeName>
    <deviceName>PRL Rapid Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808183</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:29.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808182QQ</udiDi>
    <basicUdiDi>B-808182QQ</basicUdiDi>
    <tradeName>D-808182QQ</tradeName>
    <deviceName>PROG Rapid Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808182</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:28.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808180QL</udiDi>
    <basicUdiDi>B-808180QL</basicUdiDi>
    <tradeName>D-808180QL</tradeName>
    <deviceName>E2 Rapid Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:25.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808179R3</udiDi>
    <basicUdiDi>B-808179R3</basicUdiDi>
    <tradeName>D-808179R3</tradeName>
    <deviceName>AMH Rapid Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808179</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:21.859Z</lastUpdated>
  </row>
</eudamedExport>