<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-8435232341607ZS</udiDi>
    <basicUdiDi>B-8435232341607ZS</basicUdiDi>
    <tradeName>HIALIX®</tradeName>
    <deviceName>HIALUSEPT BLACKCURRANT</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>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENT12</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:29.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-425106NM</udiDi>
    <basicUdiDi>B-425106NM</basicUdiDi>
    <tradeName>YA Dekspantenoli nenäsuihke 25ml</tradeName>
    <deviceName>Nasal spray (dekspanthenol)</deviceName>
    <manufacturerName>Galena Pharma Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>425106</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:12.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-39992JS</udiDi>
    <basicUdiDi>B-39992JS</basicUdiDi>
    <tradeName>A.Vogel Pollinosan® Hooikoorts neusspray</tradeName>
    <deviceName>Ectoin® Allergy Nasal Spray 2%</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>39992</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:03:35.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-38133GT</udiDi>
    <basicUdiDi>B-38133GT</basicUdiDi>
    <tradeName>Mucosec Pastylki do ssania</tradeName>
    <deviceName>Ectoin® Protect Lozenges Cherry</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38133</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:58:12.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-38132GR</udiDi>
    <basicUdiDi>B-38132GR</basicUdiDi>
    <tradeName>Mucosan Lutschtabletten</tradeName>
    <deviceName>Ectoin® Protect Lozenges Cherry</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38132</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:58:12.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-38123GQ</udiDi>
    <basicUdiDi>B-38123GQ</basicUdiDi>
    <tradeName>Granions® Mal de Gorge Intense</tradeName>
    <deviceName>ECTOIN® CONTAINING LOZENGES</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38068</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:58:06.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-38068H9</udiDi>
    <basicUdiDi>B-38068H9</basicUdiDi>
    <tradeName>Phytoxil Pastille Mal de Gorge miel</tradeName>
    <deviceName>Ectoin® Protect Lozenges Honey Salt</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38068</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:58:01.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-38095HC</udiDi>
    <basicUdiDi>B-38095HC</basicUdiDi>
    <tradeName>MedicaVox®</tradeName>
    <deviceName>Ectoin® Protect Lozenges Honey Lemon</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38095</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:58:00.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3760155215625WS</udiDi>
    <basicUdiDi>B-3760155215625WS</basicUdiDi>
    <tradeName>Granions® Kid Toux</tradeName>
    <deviceName>Hialusept syrop natural</deviceName>
    <manufacturerName>Gofarm Sp. z o.o. Sp. k.</manufacturerName>
    <manufacturerSrn>PL-MF-000003485</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENT40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:55:39.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3614790000460VX</udiDi>
    <basicUdiDi>B-3614790000460VX</basicUdiDi>
    <tradeName>Collurynx™</tradeName>
    <deviceName>Hialusept forte spray</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>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENT14</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:37:57.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-36021FZ</udiDi>
    <basicUdiDi>B-36021FZ</basicUdiDi>
    <tradeName>Pollinosan Allergy Nasal Spray</tradeName>
    <deviceName>Ectoin® Allergy Nasal Spray forte</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36021</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:37:38.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33045FS</udiDi>
    <basicUdiDi>B-33045FS</basicUdiDi>
    <tradeName>Phytoxil Pastille Mal de Gorge fruit rouges</tradeName>
    <deviceName>Ectoin® Protect Lozenges Cherry</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33045</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:26:17.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33044FQ</udiDi>
    <basicUdiDi>B-33044FQ</basicUdiDi>
    <tradeName>Phytoxil Pastille Mal de Gorge miel citron menthe</tradeName>
    <deviceName>Ectoin® Protect Lozenges Honey Lemon</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33044</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:26:12.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33043FN</udiDi>
    <basicUdiDi>B-33043FN</basicUdiDi>
    <tradeName>HUMER PHARYNGITE</tradeName>
    <deviceName>Ectoin® Soft Lozenges</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33043</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:26:11.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33040FG</udiDi>
    <basicUdiDi>B-33040FG</basicUdiDi>
    <tradeName>A.Vogel Pollinosan® Hooikoorts neusspray</tradeName>
    <deviceName>Ectoin® Allergy Nasal Spray 2%</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33040</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:26:11.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30603FK</udiDi>
    <basicUdiDi>B-30603FK</basicUdiDi>
    <tradeName>HUMER PHARYNGITE</tradeName>
    <deviceName>Ectoin® Soft Lozenges</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30603</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:08:19.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>18961104263649</udiDi>
    <basicUdiDi>B-18961104263649</basicUdiDi>
    <tradeName>Wrangler Instruments</tradeName>
    <deviceName>LOOP,EAR,BILLEAU,FIG1,2X3MM,16,5CM,SMOOTH EDGE</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>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13-510-01BK</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:03:30.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>18961104263533</udiDi>
    <basicUdiDi>B-18961104263533</basicUdiDi>
    <tradeName>Wrangler Instruments</tradeName>
    <deviceName>LOOP,EAR,BILLEAU,FIG3, 4X7MM,16,5CM,SMOOTH EDGE</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>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13-510-03BK</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:03:12.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029902519</udiDi>
    <basicUdiDi>88000299GTVS10PP</basicUdiDi>
    <tradeName>18800029902519</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENT Endoscopy Visual System / MGSI-CA-VS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T09:06:38.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029902526</udiDi>
    <basicUdiDi>88000299GTVS10PP</basicUdiDi>
    <tradeName>18800029902526</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Portable Pen Light / MGSI-CA-LS-PT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T09:06:38.144Z</lastUpdated>
  </row>
</eudamedExport>