<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DE-MF-000006543-38069UU</udiDi>
    <basicUdiDi>B-DE-MF-000006543-38069UU</basicUdiDi>
    <tradeName>Hydralin ConfortVaginal</tradeName>
    <deviceName>Ectoin® Vaginal Gel</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0899</emdnCode>
    <emdnDescription>GYNAECOLOGICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38069</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:22:11.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DE-MF-000006543-38030TZ</udiDi>
    <basicUdiDi>B-DE-MF-000006543-38030TZ</basicUdiDi>
    <tradeName>CanesMeno Hydration &amp; Comfort Gel</tradeName>
    <deviceName>Ectoin® Vaginal Gel</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0899</emdnCode>
    <emdnDescription>GYNAECOLOGICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38030</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:20:31.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DE-MF-000006543-32996V2</udiDi>
    <basicUdiDi>B-DE-MF-000006543-32996V2</basicUdiDi>
    <tradeName>Ectoin® Vaginal Gel</tradeName>
    <deviceName>Ectoin® Vaginal Gel</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0899</emdnCode>
    <emdnDescription>GYNAECOLOGICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32996</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:19:50.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DE-MF-000006543-30751TL</udiDi>
    <basicUdiDi>B-DE-MF-000006543-30751TL</basicUdiDi>
    <tradeName>Ectifem żel</tradeName>
    <deviceName>Ectoin® Vaginal Gel</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0899</emdnCode>
    <emdnDescription>GYNAECOLOGICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30751</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:19:24.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D42211E50YT</udiDi>
    <basicUdiDi>B-D42211E50YT</basicUdiDi>
    <tradeName>Cumlaude lab: PREBIOTIC Ovulos</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISTITUTO GANASSINI S.p.A. di Ricerche Biochimiche</manufacturerName>
    <manufacturerSrn>IT-MF-000027942</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D42211E50</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:25.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D42211E40YQ</udiDi>
    <basicUdiDi>B-D42211E40YQ</basicUdiDi>
    <tradeName>Cumlaude lab: Ovulos CLX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISTITUTO GANASSINI S.p.A. di Ricerche Biochimiche</manufacturerName>
    <manufacturerSrn>IT-MF-000027942</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D42211E40</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:24.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D42211E30YM</udiDi>
    <basicUdiDi>B-D42211E30YM</basicUdiDi>
    <tradeName>Cumlaude lab: LUBRIPIU' Ovulos</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISTITUTO GANASSINI S.p.A. di Ricerche Biochimiche</manufacturerName>
    <manufacturerSrn>IT-MF-000027942</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D42211E30</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:23.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D42211C90YV</udiDi>
    <basicUdiDi>B-D42211C90YV</basicUdiDi>
    <tradeName>Cumlaude lab: GINESEDA Ovulos</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISTITUTO GANASSINI S.p.A. di Ricerche Biochimiche</manufacturerName>
    <manufacturerSrn>IT-MF-000027942</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D42211C90</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:22.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D42011N20Z5</udiDi>
    <basicUdiDi>B-D42011N20Z5</basicUdiDi>
    <tradeName>Cumlaude lab: PREBIOTIC Ovulos</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISTITUTO GANASSINI S.p.A. di Ricerche Biochimiche</manufacturerName>
    <manufacturerSrn>IT-MF-000027942</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D42011N20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:18.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D42011N10Z2</udiDi>
    <basicUdiDi>B-D42011N10Z2</basicUdiDi>
    <tradeName>Cumlaude lab: Ovulos CLX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISTITUTO GANASSINI S.p.A. di Ricerche Biochimiche</manufacturerName>
    <manufacturerSrn>IT-MF-000027942</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D42011N10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:17.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D42011N00YX</udiDi>
    <basicUdiDi>B-D42011N00YX</basicUdiDi>
    <tradeName>Cumlaude lab: GINESEDA Ovulos</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISTITUTO GANASSINI S.p.A. di Ricerche Biochimiche</manufacturerName>
    <manufacturerSrn>IT-MF-000027942</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D42011N00</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:17.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D42011M80ZJ</udiDi>
    <basicUdiDi>B-D42011M80ZJ</basicUdiDi>
    <tradeName>Cumlaude lab: LUBRIPIU' Ovulos</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ISTITUTO GANASSINI S.p.A. di Ricerche Biochimiche</manufacturerName>
    <manufacturerSrn>IT-MF-000027942</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D42011M80</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:16.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNP03WY</udiDi>
    <basicUdiDi>B-CNP03WY</basicUdiDi>
    <tradeName>Candinorm PRO ovulos</tradeName>
    <deviceName>Candinorm PRO</deviceName>
    <manufacturerName>Schwabe Pharma Italia</manufacturerName>
    <manufacturerSrn>IT-MF-000029129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CNP03</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:09:38.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNP02WW</udiDi>
    <basicUdiDi>B-CNP02WW</basicUdiDi>
    <tradeName>Candinorm PRO campione</tradeName>
    <deviceName>Candinorm PRO</deviceName>
    <manufacturerName>Schwabe Pharma Italia</manufacturerName>
    <manufacturerSrn>IT-MF-000029129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CNP02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:09:38.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNP01WU</udiDi>
    <basicUdiDi>B-CNP01WU</basicUdiDi>
    <tradeName>Candinorm PRO</tradeName>
    <deviceName>Candinorm PRO</deviceName>
    <manufacturerName>Schwabe Pharma Italia</manufacturerName>
    <manufacturerSrn>IT-MF-000029129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CNP01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:09:34.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CIE01U2</udiDi>
    <basicUdiDi>B-CIE01U2</basicUdiDi>
    <tradeName>Candinorm Idrogel Equilibra</tradeName>
    <deviceName>Candinorm Idrogel Equilibra</deviceName>
    <manufacturerName>Schwabe Pharma Italia</manufacturerName>
    <manufacturerSrn>IT-MF-000029129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIE01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:05:35.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BEMF000032366POLYB001CC</udiDi>
    <basicUdiDi>B-BEMF000032366POLYB001CC</basicUdiDi>
    <tradeName>POLYBACTUM</tradeName>
    <deviceName>POLYBACTUM</deviceName>
    <manufacturerName>Effik Benelux NV/SA</manufacturerName>
    <manufacturerSrn>BE-MF-000032366</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POLYBACTUM</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:23:36.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>B199GDCT37M60</udiDi>
    <basicUdiDi>B-B199GDCT37M60</basicUdiDi>
    <tradeName>CT37stax</tradeName>
    <deviceName>CT37stax Benchtop Incubator</deviceName>
    <manufacturerName>Planer Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000002773</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U080299</emdnCode>
    <emdnDescription>DEVICES FOR ASSISTED REPRODUCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDCT37-M</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:42:22.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>B199GDCT37M50</udiDi>
    <basicUdiDi>B-B199GDCT37M50</basicUdiDi>
    <tradeName>CT37</tradeName>
    <deviceName>CT37</deviceName>
    <manufacturerName>Planer Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000002773</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U080299</emdnCode>
    <emdnDescription>DEVICES FOR ASSISTED REPRODUCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDCT37-M-5</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:42:18.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>B199GDCT37M40</udiDi>
    <basicUdiDi>B-B199GDCT37M40</basicUdiDi>
    <tradeName>CT37</tradeName>
    <deviceName>CT37</deviceName>
    <manufacturerName>Planer Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000002773</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U080299</emdnCode>
    <emdnDescription>DEVICES FOR ASSISTED REPRODUCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDCT37-M-4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:42:18.067Z</lastUpdated>
  </row>
</eudamedExport>