<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-074085P2</udiDi>
    <basicUdiDi>B-074085P2</basicUdiDi>
    <tradeName>Biolife Hemorrhoid gel spray</tradeName>
    <deviceName>Hemorrhoid gel Spray</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>074085</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:33:27.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-074009NJ</udiDi>
    <basicUdiDi>B-074009NJ</basicUdiDi>
    <tradeName>WeFix Wart Away 2 ml</tradeName>
    <deviceName>Wart Away 2 ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>074009</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:33:25.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-073897QA</udiDi>
    <basicUdiDi>B-073897QA</basicUdiDi>
    <tradeName>YogaMedic</tradeName>
    <deviceName>YogaMedic Hamorrhoiden Gel 40ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073897</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:33:20.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-073965Q2</udiDi>
    <basicUdiDi>B-073965Q2</basicUdiDi>
    <tradeName>JutaVit Wart Away 2 ml</tradeName>
    <deviceName>Wart Away 2 ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>073965</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:33:19.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-073866PX</udiDi>
    <basicUdiDi>B-073866PX</basicUdiDi>
    <tradeName>ActiveMed</tradeName>
    <deviceName>ActiveMed Hamerrhoid gel 40ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>073866</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:33:17.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-073804P9</udiDi>
    <basicUdiDi>B-073804P9</basicUdiDi>
    <tradeName>Evolsin</tradeName>
    <deviceName>Evolsin Hamorrhoiden gel 40ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073804</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:33:00.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-073620NV</udiDi>
    <basicUdiDi>B-073620NV</basicUdiDi>
    <tradeName>APO Warzenentferner 2 ml</tradeName>
    <deviceName>Warzenentferner 2 ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073620</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:32:52.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-073545P8</udiDi>
    <basicUdiDi>B-073545P8</basicUdiDi>
    <tradeName>Behrend Warzenentferner 2 ml</tradeName>
    <deviceName>Warzenentferner 2 ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073545</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:32:44.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-073415NS</udiDi>
    <basicUdiDi>B-073415NS</basicUdiDi>
    <tradeName>Acetocaustin 2 ml</tradeName>
    <deviceName>Acetocaustin 2 ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073415</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:23.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-073194NZ</udiDi>
    <basicUdiDi>B-073194NZ</basicUdiDi>
    <tradeName>Bliyabelet Gel 2ml</tradeName>
    <deviceName>Bliyabelet Gel 2ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073194</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:04:23.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-073170NK</udiDi>
    <basicUdiDi>B-073170NK</basicUdiDi>
    <tradeName>Dermovitamina Verruche 2 ml</tradeName>
    <deviceName>Dermovitamina Verruche 2 ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073170</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:04:19.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-072982PT</udiDi>
    <basicUdiDi>B-072982PT</basicUdiDi>
    <tradeName>Verrumax 2 ml</tradeName>
    <deviceName>Verrumax 2 ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>072982</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:54:29.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290100665077</udiDi>
    <basicUdiDi>B-07290100665077</basicUdiDi>
    <tradeName>07290100665077</tradeName>
    <deviceName>Sterile Lubricant Jelly</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53J505-8000-000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:11:32.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290100663301</udiDi>
    <basicUdiDi>B-07290100663301</basicUdiDi>
    <tradeName>07290100663301</tradeName>
    <deviceName>Sterile Lubricating Jelly</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53J805-5001-000A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:11:31.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-072623NU</udiDi>
    <basicUdiDi>B-072623NU</basicUdiDi>
    <tradeName>Kidsner Wart Remover 2 ml</tradeName>
    <deviceName>Wart Remover 2 ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>072623</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:04:15.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-072548P7</udiDi>
    <basicUdiDi>B-072548P7</basicUdiDi>
    <tradeName>LA</tradeName>
    <deviceName>LA Hemorrhoid gel 40ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>072548</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:04:08.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-072081NC</udiDi>
    <basicUdiDi>B-072081NC</basicUdiDi>
    <tradeName>Molysky</tradeName>
    <deviceName>Molysky Hemorrhoid gel 40ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>072081</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:03:39.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-071480NP</udiDi>
    <basicUdiDi>B-071480NP</basicUdiDi>
    <tradeName>Lucovital</tradeName>
    <deviceName>Lucovital Hemorrhoid gel 40ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>071480</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:03:19.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-071084NB</udiDi>
    <basicUdiDi>B-071084NB</basicUdiDi>
    <tradeName>Derma Forte Wart Away 2ml</tradeName>
    <deviceName>Wart away CE 2 ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>071084</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:03:06.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>08588005606318</udiDi>
    <basicUdiDi>8588010113RECTOVENALNF</basicUdiDi>
    <tradeName>RECTOVENAL® ACUTE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VULM s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000001981</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZV-1490024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:18:37.854Z</lastUpdated>
  </row>
</eudamedExport>