<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DE-MF-000006543-30322SR</udiDi>
    <basicUdiDi>B-DE-MF-000006543-30322SR</basicUdiDi>
    <tradeName>ALECTOIN</tradeName>
    <deviceName>ECTOIN ALLERGY EYE DROPS 2%</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030299</emdnCode>
    <emdnDescription>OPHTHALMOLOGY, LIQUID FLUIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30322</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:18:16.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DE-MF-000006543-30250SR</udiDi>
    <basicUdiDi>B-DE-MF-000006543-30250SR</basicUdiDi>
    <tradeName>Ectoin®Sicca Eye Drops + HA 0.2%</tradeName>
    <deviceName>Ectoin® Sicca Eye Drops + HA 0.2%</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030299</emdnCode>
    <emdnDescription>OPHTHALMOLOGY, LIQUID FLUIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:18:11.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DE-MF-000006543-30261SW</udiDi>
    <basicUdiDi>B-DE-MF-000006543-30261SW</basicUdiDi>
    <tradeName>Ectoal</tradeName>
    <deviceName>medEctoin® Allergy Eye Drops 2%</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030299</emdnCode>
    <emdnDescription>OPHTHALMOLOGY, LIQUID FLUIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30261</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:18:10.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DE-MF-000006543-30226SU</udiDi>
    <basicUdiDi>B-DE-MF-000006543-30226SU</basicUdiDi>
    <tradeName>Vizol S ALLERGY</tradeName>
    <deviceName>Ectoin® Allergy Eye Drops 2%</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030299</emdnCode>
    <emdnDescription>OPHTHALMOLOGY, LIQUID FLUIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30226</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:18:06.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DE-MF-000006543-30125SM</udiDi>
    <basicUdiDi>B-DE-MF-000006543-30125SM</basicUdiDi>
    <tradeName>Ectoin® Sicca Eye Drops</tradeName>
    <deviceName>Ectoin® Sicca Eye Drops</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030299</emdnCode>
    <emdnDescription>OPHTHALMOLOGY, LIQUID FLUIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:17:50.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DE-MF-000006543-30085T2</udiDi>
    <basicUdiDi>B-DE-MF-000006543-30085T2</basicUdiDi>
    <tradeName>Ectoin® Allergy Eye Drops 2%</tradeName>
    <deviceName>Ectoin® Allergy Eye Drops 2%</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030299</emdnCode>
    <emdnDescription>OPHTHALMOLOGY, LIQUID FLUIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30085</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:17:46.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DE-MF-000006543-30084SY</udiDi>
    <basicUdiDi>B-DE-MF-000006543-30084SY</basicUdiDi>
    <tradeName>Ectoin® Allergy Eye Drops 2%</tradeName>
    <deviceName>Ectoin® Allergy Eye Drops 2%</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030299</emdnCode>
    <emdnDescription>OPHTHALMOLOGY, LIQUID FLUIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30084</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:17:43.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DE-MF-000006543-30072SR</udiDi>
    <basicUdiDi>B-DE-MF-000006543-30072SR</basicUdiDi>
    <tradeName>Ectoin® Allergy Eye Drops 1%</tradeName>
    <deviceName>Ectoin® Allergy Eye Drops 1%</deviceName>
    <manufacturerName>bitop AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030299</emdnCode>
    <emdnDescription>OPHTHALMOLOGY, LIQUID FLUIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30072</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:17:41.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D15NVT65</udiDi>
    <basicUdiDi>B-D15NVT65</basicUdiDi>
    <tradeName>NAVITAE</tradeName>
    <deviceName>NAVITAE</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15NVT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:10.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D15NPRL</udiDi>
    <basicUdiDi>B-D15NPRL</basicUdiDi>
    <tradeName>NAVITAE PLUS</tradeName>
    <deviceName>NAVITAE PLUS</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15NP</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:09.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D15NIR6</udiDi>
    <basicUdiDi>B-D15NIR6</basicUdiDi>
    <tradeName>NAVI INFLA</tradeName>
    <deviceName>NAVI INFLA</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15NI</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:05.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D15FRQY</udiDi>
    <basicUdiDi>B-D15FRQY</basicUdiDi>
    <tradeName>FLORAVISION RED EYES</tradeName>
    <deviceName>FLORAVISION RED EYES - DROPS</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15FR</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:04.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D15FIQE</udiDi>
    <basicUdiDi>B-D15FIQE</basicUdiDi>
    <tradeName>NAVIVISION PLUS - IRRITATED EYES</tradeName>
    <deviceName>FLORAVISION IRRITATED EYES - DROPS</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15FI</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:03.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D15FDQ4</udiDi>
    <basicUdiDi>B-D15FDQ4</basicUdiDi>
    <tradeName>NAVIVISION PLUS - TIRED EYES</tradeName>
    <deviceName>FLORAVISION DRY EYES - DROPS</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D15FD</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T12:42:03.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D10VXS3</udiDi>
    <basicUdiDi>B-D10VXS3</basicUdiDi>
    <tradeName>VERBALUX PF</tradeName>
    <deviceName>VERBALUX PF</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D10VX</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:41.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D10VXPDNG</udiDi>
    <basicUdiDi>B-D10VXPDNG</basicUdiDi>
    <tradeName>VISIONLUX PLUS DUO</tradeName>
    <deviceName>VISIONLUX PLUS DUO</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D10VXPD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:40.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D10VXP68</udiDi>
    <basicUdiDi>B-D10VXP68</basicUdiDi>
    <tradeName>VISIONLUX PLUS</tradeName>
    <deviceName>VISIONLUX PLUS</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D10VXP</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:36.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D10NPF3L</udiDi>
    <basicUdiDi>B-D10NPF3L</basicUdiDi>
    <tradeName>NAVITAE PLUS PF</tradeName>
    <deviceName>NAVITAE PLUS PF</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D10NPF</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:35.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D10NLQK</udiDi>
    <basicUdiDi>B-D10NLQK</basicUdiDi>
    <tradeName>NAVI®LIPO</tradeName>
    <deviceName>NAVILIPO - DROPS</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D10NL</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:34.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D10NCF2D</udiDi>
    <basicUdiDi>B-D10NCF2D</basicUdiDi>
    <tradeName>NAVI NACL 5% PF</tradeName>
    <deviceName>NAVI NACL 5% PF</deviceName>
    <manufacturerName>Novax Pharma SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000011256</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q02030206</emdnCode>
    <emdnDescription>EYE LUBRICANT SOLUTIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D10NCF</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:33.019Z</lastUpdated>
  </row>
</eudamedExport>