<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08051511500062</udiDi>
    <basicUdiDi>B-08051511500062</basicUdiDi>
    <tradeName>ISDIN WOMAN OVULES VAGINAL DM - 2 OVULI</tradeName>
    <deviceName>ISDIN WOMAN OVULES VAGINAL DM - 2 OVULI</deviceName>
    <manufacturerName>ROELMI HPC SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000026619</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>R.NT.PR.MDEV.0310.6</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:13:29.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>08051511500055</udiDi>
    <basicUdiDi>B-08051511500055</basicUdiDi>
    <tradeName>Infectim plus</tradeName>
    <deviceName>Infectim Plus</deviceName>
    <manufacturerName>ROELMI HPC SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000026619</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>R.NT.PR.MDEV.0310.5</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:13:28.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>08051511500048</udiDi>
    <basicUdiDi>B-08051511500048</basicUdiDi>
    <tradeName>GYNEXELLE ACTI-GYN</tradeName>
    <deviceName>GYNEXELLE ACTI-GYN 7 pezzi</deviceName>
    <manufacturerName>ROELMI HPC SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000026619</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>R.NT.PR.MDEV.0310.3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:13:27.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>08051511500031</udiDi>
    <basicUdiDi>B-08051511500031</basicUdiDi>
    <tradeName>GYNEXELLE ACTI-GYN</tradeName>
    <deviceName>GYNEXELLE ACTI-GYN 2 pezzi</deviceName>
    <manufacturerName>ROELMI HPC SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000026619</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>R.NT.PR.MDEV.0310.2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:13:23.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>08051511500017</udiDi>
    <basicUdiDi>B-08051511500017</basicUdiDi>
    <tradeName>BACTIGYN OVULES</tradeName>
    <deviceName>BACTIGYN OVULES 7</deviceName>
    <manufacturerName>ROELMI HPC SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000026619</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>R.NT.PR.MEDV.0310</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:13:23.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>08051511500000</udiDi>
    <basicUdiDi>B-08051511500000</basicUdiDi>
    <tradeName>Intimique ovuli</tradeName>
    <deviceName>Intimique</deviceName>
    <manufacturerName>ROELMI HPC SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000026619</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>R.NT.PR.MDEV.0300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:13:22.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033837330165</udiDi>
    <basicUdiDi>B-08033837330165</basicUdiDi>
    <tradeName>Filme Gyno-V12</tradeName>
    <deviceName>Filme Gyno-V12</deviceName>
    <manufacturerName>Panin Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000020738</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>FEGYNO-V12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:29:13.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033837330158</udiDi>
    <basicUdiDi>B-08033837330158</basicUdiDi>
    <tradeName>Filme Gyno-V</tradeName>
    <deviceName>Filme Gyno-V</deviceName>
    <manufacturerName>Panin Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000020738</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>FEGYNO-V</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:29:12.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>08029241107318</udiDi>
    <basicUdiDi>B-08029241107318</basicUdiDi>
    <tradeName>INTIMA+ LAVANDA VAGINALE</tradeName>
    <deviceName>INTIMA+ LAVANDA VAGINALE</deviceName>
    <manufacturerName>SO.DI.CO. S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000043852</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8029241107318</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:51:13.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-076652PX</udiDi>
    <basicUdiDi>B-076652PX</basicUdiDi>
    <tradeName>Feminis vajinal 6 kapsül</tradeName>
    <deviceName>Vajinal 6 kapsül</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</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>Artık piyasada değil</deviceStatus>
    <reference>076652</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:04:19.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-076515PL</udiDi>
    <basicUdiDi>B-076515PL</basicUdiDi>
    <tradeName>Feminis vajinal jel</tradeName>
    <deviceName>Vajinal jel</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</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>076515</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:04:12.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640108050786</udiDi>
    <basicUdiDi>B-07640108050786</basicUdiDi>
    <tradeName>Ardo Natal Restore</tradeName>
    <deviceName>Ardo Natal Restore</deviceName>
    <manufacturerName>Ardo medical AG</manufacturerName>
    <manufacturerSrn>CH-MF-000016526</manufacturerSrn>
    <authorisedRepresentativeName>ARDO medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000014440</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>66.00.16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:38:20.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640108050762</udiDi>
    <basicUdiDi>B-07640108050762</basicUdiDi>
    <tradeName>Ardo Natal Restore</tradeName>
    <deviceName>Ardo Natal Restore</deviceName>
    <manufacturerName>Ardo medical AG</manufacturerName>
    <manufacturerSrn>CH-MF-000016526</manufacturerSrn>
    <authorisedRepresentativeName>ARDO medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000014440</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>66.00.13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:38:16.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-076225P8</udiDi>
    <basicUdiDi>B-076225P8</basicUdiDi>
    <tradeName>Matas Medicare Vaginal Gel</tradeName>
    <deviceName>Vaginal Gel</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</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>076225</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:04:33.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-076195PQ</udiDi>
    <basicUdiDi>B-076195PQ</basicUdiDi>
    <tradeName>Lucovital Vaginal infec 6c</tradeName>
    <deviceName>Vaginal infec 6c</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</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>Artık piyasada değil</deviceStatus>
    <reference>076195</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:04:28.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-076126P5</udiDi>
    <basicUdiDi>B-076126P5</basicUdiDi>
    <tradeName>Lucovital Vaginal dryness</tradeName>
    <deviceName>Vaginal Dryness Ovules</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</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>Artık piyasada değil</deviceStatus>
    <reference>076126</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:54:35.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-076102NP</udiDi>
    <basicUdiDi>B-076102NP</basicUdiDi>
    <tradeName>Medivag Hydro ovules</tradeName>
    <deviceName>Vaginal Dryness Ovules</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</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>Artık piyasada değil</deviceStatus>
    <reference>076102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:54:34.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-074702P7</udiDi>
    <basicUdiDi>B-074702P7</basicUdiDi>
    <tradeName>Kruidvat Vaginale gel</tradeName>
    <deviceName>Vaginale gel</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</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>074702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:34:19.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-074221NJ</udiDi>
    <basicUdiDi>B-074221NJ</basicUdiDi>
    <tradeName>BioLife Vaginal Infections 6c</tradeName>
    <deviceName>Vaginal Infections 6c</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</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>Artık piyasada değil</deviceStatus>
    <reference>074221</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:33:39.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-074153NS</udiDi>
    <basicUdiDi>B-074153NS</basicUdiDi>
    <tradeName>BioLife Vaginal dryness</tradeName>
    <deviceName>Vaginal Dryness Ovules</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</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>Artık piyasada değil</deviceStatus>
    <reference>074153</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:33:32.897Z</lastUpdated>
  </row>
</eudamedExport>