<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  </row>
  <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>
    <riskClass>Sınıf I</riskClass>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
    <riskClass>Sınıf I</riskClass>
    <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>
  </row>
  <row>
    <udiDi>08034125188796</udiDi>
    <basicUdiDi>803412518TF0974</basicUdiDi>
    <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>
  </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-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>
  </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-3700225602641QG</udiDi>
    <basicUdiDi>B-3700225602641QG</basicUdiDi>
    <tradeName>Pediakid Oti-Protect</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>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:55:13.522Z</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>08961104260788</udiDi>
    <basicUdiDi>B-08961104260788</basicUdiDi>
    <tradeName>Wrangler Instruments</tradeName>
    <deviceName>HARTMANN Tuning Fork, C2-512, ss</deviceName>
    <manufacturerName>Wrangler Instruments</manufacturerName>
    <manufacturerSrn>PK-MF-000009409</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-250-C2-512MD</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:16:52.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>08961104260771</udiDi>
    <basicUdiDi>B-08961104260771</basicUdiDi>
    <tradeName>Wrangler Instruments</tradeName>
    <deviceName>HARTMANN Tuning Fork, C1-256, ss</deviceName>
    <manufacturerName>Wrangler Instruments</manufacturerName>
    <manufacturerSrn>PK-MF-000009409</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-250-C1-256MD</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:16:45.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>08961104260764</udiDi>
    <basicUdiDi>B-08961104260764</basicUdiDi>
    <tradeName>Wrangler Instruments</tradeName>
    <deviceName>HARTMANN Tuning Fork, C0-128, ss</deviceName>
    <manufacturerName>Wrangler Instruments</manufacturerName>
    <manufacturerSrn>PK-MF-000009409</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-250-C0-128MD</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:16:44.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906039310696</udiDi>
    <basicUdiDi>B-08906039310696</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Ear wick Fenestrated (9.0 Dia.x15.0) mm</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E7169</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:56:56.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906039310702</udiDi>
    <basicUdiDi>B-08906039310702</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Ear wick Fenestrated (9.0 Dia.x24.0) mm</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E7170</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:56:51.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906039310689</udiDi>
    <basicUdiDi>B-08906039310689</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Ear Pack with String (12.0Dia.x24.0)mm</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E7168</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:56:50.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906039310672</udiDi>
    <basicUdiDi>B-08906039310672</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Ear Pack with String (12.0Dia.x15.0)mm</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E7167</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:56:35.682Z</lastUpdated>
  </row>
</eudamedExport>