<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06009888639016</udiDi>
    <basicUdiDi>60099003902UBTUL</basicUdiDi>
    <tradeName>Ellavi UBT</tradeName>
    <deviceName>Ellavi UBT</deviceName>
    <manufacturerName>SINAPI Biomedical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000012126</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U100102</emdnCode>
    <emdnDescription>POSTPARTUM INTRAUTERINE CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UBT-Deluxe</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:48:13.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>00610075973255</udiDi>
    <basicUdiDi>610075D01P030S00606H</basicUdiDi>
    <tradeName>Hollister</tradeName>
    <deviceName>Male Incontinence Sheath (Catheter)</deviceName>
    <manufacturerName>Hollister Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000027818</manufacturerSrn>
    <authorisedRepresentativeName>Hollister ULC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000022119</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>97325</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:44:38.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999542973642</udiDi>
    <basicUdiDi>599954297GM0930QF</basicUdiDi>
    <tradeName>GM felnőtt nadrágpelenka S (1200 ml)</tradeName>
    <deviceName>VIZELETFELSZÍVÓ ÉS DEFEKÁLÁSI SEGÉDESZKÖZÖK</deviceName>
    <manufacturerName>PATELLA-96 Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság</manufacturerName>
    <manufacturerSrn>HU-MF-000004588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070299</emdnCode>
    <emdnDescription>EXTERNAL DEVICES FOR THE TREATMENT OF INCONTINENCE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GM felnőtt nadrágpelenka S (1200 ml)</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:38:04.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999542971624</udiDi>
    <basicUdiDi>599954297GM0940QJ</basicUdiDi>
    <tradeName>GM betegalátét 40x60 cm</tradeName>
    <deviceName>BETEGALÁTÉTEK</deviceName>
    <manufacturerName>PATELLA-96 Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság</manufacturerName>
    <manufacturerSrn>HU-MF-000004588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GM egyszerhasználatos antidecubitus alátét 40x60 cm</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:37:55.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>05996617000050</udiDi>
    <basicUdiDi>5996617ADAPTER7F</basicUdiDi>
    <tradeName>IALUADAPTER/UroDapter</tradeName>
    <deviceName>Urológiai Fecskendő Adapter</deviceName>
    <manufacturerName>Pharmico Medical Korlátolt felelősségi társaság - MF</manufacturerName>
    <manufacturerSrn>HU-MF-000018352</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0199</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>www.urosystem.hu</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:29:44.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944757500039</udiDi>
    <basicUdiDi>5944757502halovaovulepcPE</basicUdiDi>
    <tradeName>Halova</tradeName>
    <deviceName>Halova ovules</deviceName>
    <manufacturerName>Perfect Care Manufacturing SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000024062</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DM12</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:17:58.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944757500015</udiDi>
    <basicUdiDi>59447575ovulevaginale01ST</basicUdiDi>
    <tradeName>Cerviron</tradeName>
    <deviceName>Cerviron</deviceName>
    <manufacturerName>Perfect Care Manufacturing SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000024062</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DM01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:17:58.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906188005491</udiDi>
    <basicUdiDi>5906188Aplikatory-kI3U</basicUdiDi>
    <tradeName>APLIKATOR DOPOCHWOWY 100</tradeName>
    <deviceName>APLIKATORY DOPOCHWOWE</deviceName>
    <manufacturerName>Lubelskie Zakłady Farmaceutyczne "POLFA" Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000015608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0899</emdnCode>
    <emdnDescription>GYNAECOLOGICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QAPL-0001-000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:12:57.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906168942259</udiDi>
    <basicUdiDi>59061689422SUR019M2</basicUdiDi>
    <tradeName>Sealing Connector (T-Piece)</tradeName>
    <deviceName>SEALING CONNECTOR (T-PIECE)</deviceName>
    <manufacturerName>Calyx Medical Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000038787</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U090199</emdnCode>
    <emdnDescription>URINARY STONE RETRIEVAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUR019</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:12:45.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906168942242</udiDi>
    <basicUdiDi>59061689422SUR021LM</basicUdiDi>
    <tradeName>Sealing Connector (S-Piece)</tradeName>
    <deviceName>SEALING CONNECTOR (S-Piece)</deviceName>
    <manufacturerName>Calyx Medical Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000038787</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U090199</emdnCode>
    <emdnDescription>URINARY STONE RETRIEVAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUR021</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:12:45.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906168942235</udiDi>
    <basicUdiDi>59061689422SUR020LK</basicUdiDi>
    <tradeName>Sealing Connector (Y-Piece)</tradeName>
    <deviceName>SEALING CONNECTOR (Y-PIECE)</deviceName>
    <manufacturerName>Calyx Medical Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000038787</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U090199</emdnCode>
    <emdnDescription>URINARY STONE RETRIEVAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUR020</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:12:45.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>05905567844713</udiDi>
    <basicUdiDi>59055678447001ZH</basicUdiDi>
    <tradeName>ONIRY Spectrometer</tradeName>
    <deviceName>ONIRY Spectrometer</deviceName>
    <manufacturerName>OASIS Diagnostics S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000018772</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0899</emdnCode>
    <emdnDescription>GYNAECOLOGICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:07:37.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>05905567844706</udiDi>
    <basicUdiDi>59055678447002ZK</basicUdiDi>
    <tradeName>ONIRY Probe</tradeName>
    <deviceName>ONIRY Probe</deviceName>
    <manufacturerName>OASIS Diagnostics S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000018772</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0899</emdnCode>
    <emdnDescription>GYNAECOLOGICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:07:34.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>05905090198901</udiDi>
    <basicUdiDi>59050901989fertilityVS</basicUdiDi>
    <tradeName>EMBRYOAID</tradeName>
    <deviceName>EMBRYOAID</deviceName>
    <manufacturerName>MIM Fertility Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000030821</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U080299</emdnCode>
    <emdnDescription>DEVICES FOR ASSISTED REPRODUCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EMBRYOAID</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:58:01.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>05905178376719</udiDi>
    <basicUdiDi>5904347808GINCA</basicUdiDi>
    <tradeName>PERFECT G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kinesis Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000023594</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0899</emdnCode>
    <emdnDescription>GYNAECOLOGICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PERFECT G</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:44:25.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903260909463</udiDi>
    <basicUdiDi>5904335216zel/dopX4</basicUdiDi>
    <tradeName>Lactoviva gel</tradeName>
    <deviceName>Żel dopochwowy/ Vaginal gel</deviceName>
    <manufacturerName>LABORATOIRE L'IDEAL Parisien Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000005402</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lactoviva gel Wyrób pakowany po 7 tub  w kartoniku jednostkowym wraz z instrukcją używania</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:36:20.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901179933852</udiDi>
    <basicUdiDi>5904335216globul/dopEL</basicUdiDi>
    <tradeName>Rigenya</tradeName>
    <deviceName>Globulki dopochwowe/ Vaginal globules</deviceName>
    <manufacturerName>LABORATOIRE L'IDEAL Parisien Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000005402</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rigenya 2 sztuki globulek w kartoniku jednostkowym wraz z instrukcją używania Wersja językowa : Włoska</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:36:19.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901179933807</udiDi>
    <basicUdiDi>5904335216lub/wodUX</basicUdiDi>
    <tradeName>DOZ MED HYDROINTIMA ŻEL INTYMNY</tradeName>
    <deviceName>Lubrykant wodny/ Water lubricant</deviceName>
    <manufacturerName>LABORATOIRE L'IDEAL Parisien Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000005402</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOZ MED HYDROINTIMA ŻEL INTYMNY w tubie 75 ml</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:30:31.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260018197482</udiDi>
    <basicUdiDi>5904335216zel/dopX4</basicUdiDi>
    <tradeName>ELANEE Vaginal-Gel</tradeName>
    <deviceName>Żel dopochwowy/ Vaginal gel</deviceName>
    <manufacturerName>LABORATOIRE L'IDEAL Parisien Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000005402</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0803</emdnCode>
    <emdnDescription>VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELANEE Vaginal-Gel 7 applicators DE, EN, FR,  IT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:30:30.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260018197390</udiDi>
    <basicUdiDi>5904335216globul/dopEL</basicUdiDi>
    <tradeName>ELANEE Vaginal-Ovula</tradeName>
    <deviceName>Globulki dopochwowe/ Vaginal globules</deviceName>
    <manufacturerName>LABORATOIRE L'IDEAL Parisien Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000005402</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U089005</emdnCode>
    <emdnDescription>PESSARIANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELANEE Vaginal-Ovula 10 Vaginal-Ovula, DE, EN, FR, IT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:30:29.240Z</lastUpdated>
  </row>
</eudamedExport>