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    <tradeName>Cue Cap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drugs Minerals and Generics Italia S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000024945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80CAP008A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:05:24.482Z</lastUpdated>
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    <udiDi>D-INSTARETMD6201U2</udiDi>
    <basicUdiDi>B-INSTARETMD6201U2</basicUdiDi>
    <tradeName>INSTARET HERBAL</tradeName>
    <deviceName>INSTARET HERBAL</deviceName>
    <manufacturerName>UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.</manufacturerName>
    <manufacturerSrn>GR-MF-000032960</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>INSTARET HERBAL</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:40:17.555Z</lastUpdated>
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  <row>
    <udiDi>D-GocceAuricVV</udiDi>
    <basicUdiDi>B-GocceAuricVV</basicUdiDi>
    <tradeName>OTOSAN</tradeName>
    <deviceName>Gocce Auricolari</deviceName>
    <manufacturerName>Otosan Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000017617</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040201</emdnCode>
    <emdnDescription>EAR DROPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1000011231</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:44:16.695Z</lastUpdated>
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    <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>
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  <row>
    <udiDi>D-DRYEARMD460330XU</udiDi>
    <basicUdiDi>B-DRYEARMD460330XU</basicUdiDi>
    <tradeName>DRY EAR</tradeName>
    <deviceName>DRY EAR</deviceName>
    <manufacturerName>IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.</manufacturerName>
    <manufacturerSrn>GR-MF-000032958</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040201</emdnCode>
    <emdnDescription>EAR DROPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRY EAR</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:13:42.170Z</lastUpdated>
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  <row>
    <udiDi>D-DRYEARMD460310XN</udiDi>
    <basicUdiDi>B-DRYEARMD460310XN</basicUdiDi>
    <tradeName>DRY EAR</tradeName>
    <deviceName>DRY EAR</deviceName>
    <manufacturerName>IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.</manufacturerName>
    <manufacturerSrn>GR-MF-000032958</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q03040201</emdnCode>
    <emdnDescription>EAR DROPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRY EAR</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:13:41.418Z</lastUpdated>
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  <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>
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  <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>
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  <row>
    <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>
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    <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>
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    <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>
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  <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <udiDi>89080225670490</udiDi>
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    <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>
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    <legislation>MDD</legislation>
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    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:42:16.217Z</lastUpdated>
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    <udiDi>89080225670322</udiDi>
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    <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>
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