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<eudamedExport entity="devices">
  <row>
    <udiDi>D-060842NH</udiDi>
    <basicUdiDi>B-060842NH</basicUdiDi>
    <tradeName>PL Private Label</tradeName>
    <deviceName>PL Private label</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>060842</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T07:13:38.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-060380MY</udiDi>
    <basicUdiDi>B-060380MY</basicUdiDi>
    <tradeName>Medolin</tradeName>
    <deviceName>Medolin Anti Ohrenschmalz 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>060380</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T07:13:32.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060180256722</udiDi>
    <basicUdiDi>B-05060180256722</basicUdiDi>
    <tradeName>Shah Vent Tube with wire 1.14 mm</tradeName>
    <deviceName>Aural Ventilation Tubes</deviceName>
    <manufacturerName>Exmoor Plastics Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025513</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040101</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION CATHETERS AND CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E115x5</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:23:34.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060180255732</udiDi>
    <basicUdiDi>B-05060180255732</basicUdiDi>
    <tradeName>Aural Speculum Oval/Bevelled, 3.6mm</tradeName>
    <deviceName>Exmoor Aural Specula</deviceName>
    <manufacturerName>Exmoor Plastics Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025513</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040101</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION CATHETERS AND CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS5</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:23:33.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250365142297</udiDi>
    <basicUdiDi>B-04250365142297</basicUdiDi>
    <tradeName>Hygrotherm plus</tradeName>
    <deviceName>Hygrotherm Plus</deviceName>
    <manufacturerName>ATMOS MedizinTechnik GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>502.0901.0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:40:13.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-04024EQ</udiDi>
    <basicUdiDi>B-04024EQ</basicUdiDi>
    <tradeName>fytofontana Aurecon drops forte Junior</tradeName>
    <deviceName>fytofontana Aurecon drops forte Junior</deviceName>
    <manufacturerName>Herb-Pharma Corporation s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000005839</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>04024</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:54:24.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976204590224</udiDi>
    <basicUdiDi>697620459ES01KU</basicUdiDi>
    <tradeName>06976204590224</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HUI ZHOU SUAN TECHNOLOGY CO., LIMITED</manufacturerName>
    <manufacturerSrn>CN-MF-000043037</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-N10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:28.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976204590231</udiDi>
    <basicUdiDi>697620459ES01KU</basicUdiDi>
    <tradeName>06976204590231</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HUI ZHOU SUAN TECHNOLOGY CO., LIMITED</manufacturerName>
    <manufacturerSrn>CN-MF-000043037</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-N11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:28.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976204590248</udiDi>
    <basicUdiDi>697620459ES01KU</basicUdiDi>
    <tradeName>06976204590248</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HUI ZHOU SUAN TECHNOLOGY CO., LIMITED</manufacturerName>
    <manufacturerSrn>CN-MF-000043037</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-N12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:47:28.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-04023EN</udiDi>
    <basicUdiDi>B-04023EN</basicUdiDi>
    <tradeName>fytofontana Aurecon drops forte</tradeName>
    <deviceName>fytofontana Aurecon drops forte</deviceName>
    <manufacturerName>Herb-Pharma Corporation s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000005839</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>04023</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:44:21.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-04022EL</udiDi>
    <basicUdiDi>B-04022EL</basicUdiDi>
    <tradeName>fytofontana Aurecon drops</tradeName>
    <deviceName>fytofontana Aurecon</deviceName>
    <manufacturerName>Herb-Pharma Corporation s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000005839</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>04022</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:44:20.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-04021EJ</udiDi>
    <basicUdiDi>B-04021EJ</basicUdiDi>
    <tradeName>fytofontana Aurecon ear spray</tradeName>
    <deviceName>fytofontana Aurecon ear spray</deviceName>
    <manufacturerName>Herb-Pharma Corporation s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000005839</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>04021</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:44:20.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-04019EX</udiDi>
    <basicUdiDi>B-04019EX</basicUdiDi>
    <tradeName>fytofontana Aurecon Forte spray</tradeName>
    <deviceName>fytofontana Aurecon Forte spray</deviceName>
    <manufacturerName>Herb-Pharma Corporation s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000005839</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>04019</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:44:17.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-04018EV</udiDi>
    <basicUdiDi>B-04018EV</basicUdiDi>
    <tradeName>fytofontana Aurecon DRY spray</tradeName>
    <deviceName>fytofontana Aurecon DRY spray</deviceName>
    <manufacturerName>Herb-Pharma Corporation s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000005839</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>04018</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:44:16.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-04006EN</udiDi>
    <basicUdiDi>B-04006EN</basicUdiDi>
    <tradeName>fytofontana Aurecon peroxide drops</tradeName>
    <deviceName>fytofontana Aurecon peroxide drops</deviceName>
    <manufacturerName>Herb-Pharma Corporation s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000005839</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>04006</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:44:00.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-04005EL</udiDi>
    <basicUdiDi>B-04005EL</basicUdiDi>
    <tradeName>fytofontana Aurecon Junior spray</tradeName>
    <deviceName>fytofontana Aurecon Junior spray</deviceName>
    <manufacturerName>Herb-Pharma Corporation s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000005839</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>04005</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:43:58.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>03859892779795</udiDi>
    <basicUdiDi>B-03859892779795</basicUdiDi>
    <tradeName>ForVax H</tradeName>
    <deviceName>ForVax H</deviceName>
    <manufacturerName>Hamapharm d.o.o.</manufacturerName>
    <manufacturerSrn>HR-MF-000023827</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GP0072</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:38:50.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>03859892779788</udiDi>
    <basicUdiDi>B-03859892779788</basicUdiDi>
    <tradeName>ForVax C</tradeName>
    <deviceName>ForVax C</deviceName>
    <manufacturerName>Hamapharm d.o.o.</manufacturerName>
    <manufacturerSrn>HR-MF-000023827</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GP0069</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:38:47.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770026518045</udiDi>
    <basicUdiDi>B-03770026518045</basicUdiDi>
    <tradeName>Laboratoires Inébios</tradeName>
    <deviceName>OTOLAYA</deviceName>
    <manufacturerName>LABORATOIRES INEBIOS</manufacturerName>
    <manufacturerSrn>FR-MF-000020166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040299</emdnCode>
    <emdnDescription>EAR IRRIGATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4701998</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:28.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0200031134</udiDi>
    <basicUdiDi>B-0200031134</basicUdiDi>
    <tradeName>DEBROX GOCCE AURICOLARI</tradeName>
    <deviceName>DEBROX GOCCE AURICOLARI</deviceName>
    <manufacturerName>Alfasigma S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000017931</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFDM001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:11:03.713Z</lastUpdated>
  </row>
</eudamedExport>