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<eudamedExport entity="devices">
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    <udiDi>D-93502990069886G</udiDi>
    <basicUdiDi>B-93502990069886G</basicUdiDi>
    <tradeName>Chemists’ Own Ear Wax Removal Drops</tradeName>
    <deviceName>Aurin Aloe</deviceName>
    <manufacturerName>Gofarm Sp. z o.o. Sp. k.</manufacturerName>
    <manufacturerSrn>PL-MF-000003485</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040201</emdnCode>
    <emdnDescription>EAR DROPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENT46</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:37.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-93384750275769Y</udiDi>
    <basicUdiDi>B-93384750275769Y</basicUdiDi>
    <tradeName>APOHEALTH Ear Wax Drops</tradeName>
    <deviceName>Aurin Aloe</deviceName>
    <manufacturerName>Gofarm Sp. z o.o. Sp. k.</manufacturerName>
    <manufacturerSrn>PL-MF-000003485</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040201</emdnCode>
    <emdnDescription>EAR DROPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENT46</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:36.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9316100306296V7</udiDi>
    <basicUdiDi>B-9316100306296V7</basicUdiDi>
    <tradeName>Pharmacy Choice Ear Wax Removal Drops</tradeName>
    <deviceName>Aurin Aloe</deviceName>
    <manufacturerName>Gofarm Sp. z o.o. Sp. k.</manufacturerName>
    <manufacturerSrn>PL-MF-000003485</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040201</emdnCode>
    <emdnDescription>EAR DROPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENT46</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:33.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9313501038191VN</udiDi>
    <basicUdiDi>B-9313501038191VN</basicUdiDi>
    <tradeName>Ear Clear Olive Oil Ear Spray</tradeName>
    <deviceName>Aurin Olivo</deviceName>
    <manufacturerName>Gofarm Sp. z o.o. Sp. k.</manufacturerName>
    <manufacturerSrn>PL-MF-000003485</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040201</emdnCode>
    <emdnDescription>EAR DROPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENT07</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:32.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-92518JB</udiDi>
    <basicUdiDi>B-92518JB</basicUdiDi>
    <tradeName>Otinova</tradeName>
    <deviceName>Otinova</deviceName>
    <manufacturerName>Circius Pharma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000013023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92518</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:29.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-92517J9</udiDi>
    <basicUdiDi>B-92517J9</basicUdiDi>
    <tradeName>Otinova</tradeName>
    <deviceName>Otinova</deviceName>
    <manufacturerName>Circius Pharma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000013023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92517</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:29.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-92512HX</udiDi>
    <basicUdiDi>B-92512HX</basicUdiDi>
    <tradeName>Otinova</tradeName>
    <deviceName>Otinova</deviceName>
    <manufacturerName>Circius Pharma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000013023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92512</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:26.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-92510HT</udiDi>
    <basicUdiDi>B-92510HT</basicUdiDi>
    <tradeName>Otinova</tradeName>
    <deviceName>Otinova</deviceName>
    <manufacturerName>Circius Pharma AB</manufacturerName>
    <manufacturerSrn>SE-MF-000013023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92510</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:57:26.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>89080225670568</udiDi>
    <basicUdiDi>B-89080225670568</basicUdiDi>
    <tradeName>NeuroEquilibrium</tradeName>
    <deviceName>Posturography</deviceName>
    <manufacturerName>NeuroEquilibrium Diagnostic Systems Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000015590</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:42:17.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>89080225670490</udiDi>
    <basicUdiDi>B-89080225670490</basicUdiDi>
    <tradeName>NeuroEquilibrium</tradeName>
    <deviceName>Video Head Impulse Test</deviceName>
    <manufacturerName>NeuroEquilibrium Diagnostic Systems Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000015590</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:42:16.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>89080225670322</udiDi>
    <basicUdiDi>B-89080225670322</basicUdiDi>
    <tradeName>NeuroEquilibrium</tradeName>
    <deviceName>Subjective Visual Vertical</deviceName>
    <manufacturerName>NeuroEquilibrium Diagnostic Systems Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000015590</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:42:15.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>89080225670254</udiDi>
    <basicUdiDi>B-89080225670254</basicUdiDi>
    <tradeName>NeuroEquilibrium</tradeName>
    <deviceName>Dynamic Visual Acuity</deviceName>
    <manufacturerName>NeuroEquilibrium Diagnostic Systems Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000015590</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:42:14.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>89080225670186</udiDi>
    <basicUdiDi>B-89080225670186</basicUdiDi>
    <tradeName>NeuroEquilibrium</tradeName>
    <deviceName>CranioCorpography</deviceName>
    <manufacturerName>NeuroEquilibrium Diagnostic Systems Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000015590</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:42:10.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>89080225670018</udiDi>
    <basicUdiDi>B-89080225670018</basicUdiDi>
    <tradeName>NeuroEquilibrium</tradeName>
    <deviceName>Videonystagmography</deviceName>
    <manufacturerName>NeuroEquilibrium Diagnostic Systems Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000015590</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:42:09.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88EN-7ZR</udiDi>
    <basicUdiDi>B-88EN-7ZR</basicUdiDi>
    <tradeName>Senti2 Spray Auricular</tradeName>
    <deviceName>Spray do ucha</deviceName>
    <manufacturerName>GLOBAL PHARMA CM S.A</manufacturerName>
    <manufacturerSrn>PL-MF-000034662</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88EN-7</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:30:12.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88EN-6ZP</udiDi>
    <basicUdiDi>B-88EN-6ZP</basicUdiDi>
    <tradeName>AKUVAX SPRAY DO HIGIENY USZU</tradeName>
    <deviceName>Spray do ucha</deviceName>
    <manufacturerName>GLOBAL PHARMA CM S.A</manufacturerName>
    <manufacturerSrn>PL-MF-000034662</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88EN-6</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:30:11.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88EN-9ZV</udiDi>
    <basicUdiDi>B-88EN-9ZV</basicUdiDi>
    <tradeName>AUDI Care</tradeName>
    <deviceName>Spray do ucha</deviceName>
    <manufacturerName>GLOBAL PHARMA CM S.A</manufacturerName>
    <manufacturerSrn>PL-MF-000034662</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88EN-9</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:30:11.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88EN-8ZT</udiDi>
    <basicUdiDi>B-88EN-8ZT</basicUdiDi>
    <tradeName>AURIN Spray do uszu</tradeName>
    <deviceName>Spray do ucha</deviceName>
    <manufacturerName>GLOBAL PHARMA CM S.A</manufacturerName>
    <manufacturerSrn>PL-MF-000034662</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88EN-8</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:30:11.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88EN-5ZM</udiDi>
    <basicUdiDi>B-88EN-5ZM</basicUdiDi>
    <tradeName>AUDI Care</tradeName>
    <deviceName>Spray do ucha</deviceName>
    <manufacturerName>GLOBAL PHARMA CM S.A</manufacturerName>
    <manufacturerSrn>PL-MF-000034662</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88EN-5</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:53.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88EN-4ZK</udiDi>
    <basicUdiDi>B-88EN-4ZK</basicUdiDi>
    <tradeName>Audio Tone</tradeName>
    <deviceName>Spray do ucha</deviceName>
    <manufacturerName>GLOBAL PHARMA CM S.A</manufacturerName>
    <manufacturerSrn>PL-MF-000034662</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88EN-4</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:52.678Z</lastUpdated>
  </row>
</eudamedExport>