<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-43000FF</udiDi>
    <basicUdiDi>B-43000FF</basicUdiDi>
    <tradeName>Lactal Balans</tradeName>
    <deviceName>Lactal Gel</deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>31-6TF</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:44:32.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-40139FS</udiDi>
    <basicUdiDi>B-40139FS</basicUdiDi>
    <tradeName>Lactofeel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>40139</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:05:40.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-40126FH</udiDi>
    <basicUdiDi>B-40126FH</basicUdiDi>
    <tradeName>Lactobor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>40126</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:05:39.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-401100LP</udiDi>
    <basicUdiDi>B-401100LP</basicUdiDi>
    <tradeName>Lactal Vaginal Gel</tradeName>
    <deviceName>Lactal Gel</deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>31-6TF0001</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:05:32.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-320865NQ</udiDi>
    <basicUdiDi>B-320865NQ</basicUdiDi>
    <tradeName>Lactal Balans</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>320865</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:18:02.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-315337NJ</udiDi>
    <basicUdiDi>B-315337NJ</basicUdiDi>
    <tradeName>Etos 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>315337</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:17:27.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30069FK</udiDi>
    <basicUdiDi>B-30069FK</basicUdiDi>
    <tradeName>Gynolind Balance Activ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>30069</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:07:11.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30062F5</udiDi>
    <basicUdiDi>B-30062F5</basicUdiDi>
    <tradeName>Canesbalance</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>30062</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:07:09.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30058FE</udiDi>
    <basicUdiDi>B-30058FE</basicUdiDi>
    <tradeName>Canesbalance</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>30058</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:07:06.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30050EW</udiDi>
    <basicUdiDi>B-30050EW</basicUdiDi>
    <tradeName>Canesbalance</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>30050</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:07:05.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30009EZ</udiDi>
    <basicUdiDi>B-30009EZ</basicUdiDi>
    <tradeName>Canesten GYNO Balance</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>30009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:06:59.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30007EV</udiDi>
    <basicUdiDi>B-30007EV</basicUdiDi>
    <tradeName>Canesbalance</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>30007</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:06:58.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30005ER</udiDi>
    <basicUdiDi>B-30005ER</basicUdiDi>
    <tradeName>Gyno-Canesbalance</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>30005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:06:56.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30006ET</udiDi>
    <basicUdiDi>B-30006ET</basicUdiDi>
    <tradeName>Canesbalance</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>30006</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:06:51.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30004EP</udiDi>
    <basicUdiDi>B-30004EP</basicUdiDi>
    <tradeName>HydralinBalance</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>30004</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:06:38.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30002EK</udiDi>
    <basicUdiDi>B-30002EK</basicUdiDi>
    <tradeName>GineCanesbalance</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>30002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:06:31.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-21877GN</udiDi>
    <basicUdiDi>B-21877GN</basicUdiDi>
    <tradeName>RedCare Vaginalzäpfchen</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>Piyasada</deviceStatus>
    <reference>21877</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:27:38.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-21712FM</udiDi>
    <basicUdiDi>B-21712FM</basicUdiDi>
    <tradeName>RedCare Vaginalkapseln 2x6</tradeName>
    <deviceName>Vaginalkapseln 2x6</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>21712</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:27:31.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-21692G8</udiDi>
    <basicUdiDi>B-21692G8</basicUdiDi>
    <tradeName>Milchsäurekur Redcare 7 tubes</tradeName>
    <deviceName>Milchsäurekur 7 tubes</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>21692</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:27:30.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-200895MW</udiDi>
    <basicUdiDi>B-200895MW</basicUdiDi>
    <tradeName>Lactal Balans</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolf Kullgren AB</manufacturerName>
    <manufacturerSrn>SE-MF-000021108</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>200895</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:33.321Z</lastUpdated>
  </row>
</eudamedExport>