<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08051511500079</udiDi>
    <basicUdiDi>B-08051511500079</basicUdiDi>
    <tradeName>ISDIN WOMAN OVULOS VAGINALES</tradeName>
    <deviceName>ISDIN WOMAN OVULES VAGINAL DM - 7 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.0310.7</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:15:18.885Z</lastUpdated>
  </row>
  <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>
</eudamedExport>