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    <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>
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    <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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    <tradeName>NeuroEquilibrium</tradeName>
    <deviceName>Video Head Impulse Test</deviceName>
    <manufacturerName>NeuroEquilibrium Diagnostic Systems Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000015590</manufacturerSrn>
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    <legislation>MDD</legislation>
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    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <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>
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    <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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    <udiDi>89080225670254</udiDi>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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  <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>
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    <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>
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  <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>
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  <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>
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  <row>
    <udiDi>D-88EN-3ZH</udiDi>
    <basicUdiDi>B-88EN-3ZH</basicUdiDi>
    <tradeName>ZINIQ Higiena 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-3</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:51.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-88EN-1ZD</udiDi>
    <basicUdiDi>B-88EN-1ZD</basicUdiDi>
    <tradeName>Contravax</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-1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:51.086Z</lastUpdated>
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  <row>
    <udiDi>D-88EN-12E6</udiDi>
    <basicUdiDi>B-88EN-12E6</basicUdiDi>
    <tradeName>Spray do higieny uszu Biolane</tradeName>
    <deviceName>Spray do ucha</deviceName>
    <manufacturerName>GLOBAL PHARMA CM S.A</manufacturerName>
    <manufacturerSrn>PL-MF-000034662</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88EN-12</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:47.303Z</lastUpdated>
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    <udiDi>D-88EN-11E4</udiDi>
    <basicUdiDi>B-88EN-11E4</basicUdiDi>
    <tradeName>Wax control</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-11</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:46.300Z</lastUpdated>
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    <udiDi>D-88EN-10E2</udiDi>
    <basicUdiDi>B-88EN-10E2</basicUdiDi>
    <tradeName>Spray do higieny uszu Cephamed</tradeName>
    <deviceName>Spray do ucha</deviceName>
    <manufacturerName>GLOBAL PHARMA CM S.A</manufacturerName>
    <manufacturerSrn>PL-MF-000034662</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Q03040199</emdnCode>
    <emdnDescription>EAR DRAINAGE AND VENTILATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88EN-10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:45.787Z</lastUpdated>
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    <udiDi>08034125188796</udiDi>
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    <tradeName>Cue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drugs Minerals and Generics Italia S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000024945</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92CUE015BGM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T16:48:18.273Z</lastUpdated>
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    <udiDi>D-84353737OTOSPRAYRC6Z</udiDi>
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    <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>
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    <udiDi>D-4897082940180CA</udiDi>
    <basicUdiDi>B-4897082940180CA</basicUdiDi>
    <tradeName>Vivo Ear Drops</tradeName>
    <deviceName>Vivo Ear Drops</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>ENT05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:17:54.379Z</lastUpdated>
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