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<eudamedExport entity="devices">
  <row>
    <udiDi>D-FONSPYCV.05B6</udiDi>
    <basicUdiDi>B-FONSPYCV.05B6</basicUdiDi>
    <tradeName>Fonitis Spray Auricolare</tradeName>
    <deviceName>Fonitis Spray Auricolare</deviceName>
    <manufacturerName>Nalkein SA</manufacturerName>
    <manufacturerSrn>CH-MF-000039092</manufacturerSrn>
    <authorisedRepresentativeName>Nalkein Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000037559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FONSPYCV.05</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:37:10.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CeruDEF</udiDi>
    <basicUdiDi>B-CeruDEF</basicUdiDi>
    <tradeName>D-CeruDEF</tradeName>
    <deviceName>Ceru Fluid/Spray</deviceName>
    <manufacturerName>Ghimas S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000017070</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ceru Fluid/Spray</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:14:14.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AMICOBORSOL.ALCOLICA3B</udiDi>
    <basicUdiDi>B-AMICOBORSOL.ALCOLICA3B</basicUdiDi>
    <tradeName>D-AMICOBORSOL.ALCOLICA3B</tradeName>
    <deviceName>AMICOBOR SOLUZIONE ALCOLICA</deviceName>
    <manufacturerName>Levante srl</manufacturerName>
    <manufacturerSrn>IT-MF-000036829</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2141</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:35:25.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AMICOBORSOL.ACQUOSALZ</udiDi>
    <basicUdiDi>B-AMICOBORSOL.ACQUOSALZ</basicUdiDi>
    <tradeName>D-AMICOBORSOL.ACQUOSALZ</tradeName>
    <deviceName>AMICOBOR SOLUZIONE ACQUOSA</deviceName>
    <manufacturerName>Levante srl</manufacturerName>
    <manufacturerSrn>IT-MF-000036829</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2140</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:35:24.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84353737OTOSPRAYRC6Z</udiDi>
    <basicUdiDi>B-84353737OTOSPRAYRC6Z</basicUdiDi>
    <tradeName>OTOSPRAY</tradeName>
    <deviceName>OTOSPRAY</deviceName>
    <manufacturerName>LABORATORIO REIG JOFRE, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000010862</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>84353737OTOSPRAYRC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:35.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3877R</udiDi>
    <basicUdiDi>B-3877R</basicUdiDi>
    <tradeName>ProtectOhr</tradeName>
    <deviceName>ProtectOhr Ohren Reinigungsspray 20ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>387</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:58:14.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3757CETF</udiDi>
    <basicUdiDi>B-3757CETF</basicUdiDi>
    <tradeName>Lucovitaal</tradeName>
    <deviceName>Lucovitaal oorspray 20ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3757CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:55:38.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-200002814E8</udiDi>
    <basicUdiDi>B-200002814E8</basicUdiDi>
    <tradeName>Rossmann</tradeName>
    <deviceName>Rossmann Altapharma Ohren Spray 20ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200002814</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:14.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-125510MR</udiDi>
    <basicUdiDi>B-125510MR</basicUdiDi>
    <tradeName>Peony Care</tradeName>
    <deviceName>Peony Care Ohrwohl 20ml</deviceName>
    <manufacturerName>PK Benelux BV</manufacturerName>
    <manufacturerSrn>NL-MF-000006672</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>125510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:55:11.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436542625449</udiDi>
    <basicUdiDi>843654262PL01358W</basicUdiDi>
    <tradeName>AUDYZEN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>STE PHARMACEUTICALS, S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000000144</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL0135</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:37:29.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436542625456</udiDi>
    <basicUdiDi>843654262PL00278S</basicUdiDi>
    <tradeName>AUDYZEN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>STE PHARMACEUTICALS, S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000000144</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL0027_30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:37:29.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436542627061</udiDi>
    <basicUdiDi>843654262PL01358W</basicUdiDi>
    <tradeName>CERUDEX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>STE PHARMACEUTICALS, S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000000144</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL0135</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:37:28.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436542627108</udiDi>
    <basicUdiDi>843654262PL00278S</basicUdiDi>
    <tradeName>EARZAC DAILY CLEAN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>STE PHARMACEUTICALS, S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000000144</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>PL0027_30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:37:28.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436542627115</udiDi>
    <basicUdiDi>843654262PL01358W</basicUdiDi>
    <tradeName>EARZAC EARWAX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>STE PHARMACEUTICALS, S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000000144</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>PL0135</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:37:28.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436542627146</udiDi>
    <basicUdiDi>843654262PL00278S</basicUdiDi>
    <tradeName>AUDYZEN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>STE PHARMACEUTICALS, S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000000144</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL0027_100_Soft</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:37:28.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436542627153</udiDi>
    <basicUdiDi>843654262PL00278S</basicUdiDi>
    <tradeName>YSANA AUDIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>STE PHARMACEUTICALS, S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000000144</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL0027_100_Soft</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:37:28.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907438982005</udiDi>
    <basicUdiDi>59074389102UQ</basicUdiDi>
    <tradeName>Gruszka Sanity z miękkim końcem nr 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Albert Polska Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000007130</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nr 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:37:52.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907438987000</udiDi>
    <basicUdiDi>59074389102UQ</basicUdiDi>
    <tradeName>Gruszka Sanity z miękkim końcem nr 7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Albert Polska Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000007130</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8107200000000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:37:52.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907438989004</udiDi>
    <basicUdiDi>59074389102UQ</basicUdiDi>
    <tradeName>Gruszka Sanity z miękkim końcem nr 9</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Albert Polska Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000007130</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8109200000000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-08T08:37:52.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595566423582</udiDi>
    <basicUdiDi>B-08595566423582</basicUdiDi>
    <tradeName>Dr. Max Audimax Olive</tradeName>
    <deviceName>Dr. Max Audimax Olive</deviceName>
    <manufacturerName>Društvo za proizvodnju i promet Esensa d.o.o.</manufacturerName>
    <manufacturerSrn>RS-MF-000031288</manufacturerSrn>
    <authorisedRepresentativeName>Salus Cons Kft.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000006177</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60000288</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:53:08.550Z</lastUpdated>
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</eudamedExport>