<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-40008FA</udiDi>
    <basicUdiDi>B-40008FA</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:54:24.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-40002EW</udiDi>
    <basicUdiDi>B-40002EW</basicUdiDi>
    <tradeName>LactalBalance</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>40002</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:42:21.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-40001EU</udiDi>
    <basicUdiDi>B-40001EU</basicUdiDi>
    <tradeName>LactalBalans</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>40001</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:42:20.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30075FE</udiDi>
    <basicUdiDi>B-30075FE</basicUdiDi>
    <tradeName>INTIMOHELP</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>30075</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:42:19.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-40007F8</udiDi>
    <basicUdiDi>B-40007F8</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>40007</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:47:48.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-507126NY</udiDi>
    <basicUdiDi>B-507126NY</basicUdiDi>
    <tradeName>Balance Activ BV Treatment Gel</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>507126</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:35:03.027Z</lastUpdated>
  </row>
  <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-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>
</eudamedExport>