<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-USMF000023322000003MX</udiDi>
    <basicUdiDi>B-USMF000023322000003MX</basicUdiDi>
    <tradeName>D-USMF000023322000003MX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AMO Manufacturing USA, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023322</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0110-2280</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:46:58.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000023322000002MV</udiDi>
    <basicUdiDi>B-USMF000023322000002MV</basicUdiDi>
    <tradeName>D-USMF000023322000002MV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AMO Manufacturing USA, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023322</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0110-3443</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:46:54.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000023322000001MT</udiDi>
    <basicUdiDi>B-USMF000023322000001MT</basicUdiDi>
    <tradeName>D-USMF000023322000001MT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AMO Manufacturing USA, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023322</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0110-3442</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:46:53.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SOOFT164ZN</udiDi>
    <basicUdiDi>B-SOOFT164ZN</basicUdiDi>
    <tradeName>FLUOROFTA</tradeName>
    <deviceName>FLUOROFTA</deviceName>
    <manufacturerName>Fidia Farmaceutici S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000026988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SOOFT164</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:46:31.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RU600118BE</udiDi>
    <basicUdiDi>B-RU600118BE</basicUdiDi>
    <tradeName>Optrex ACTISPRAY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Optima Medical Swiss AG</manufacturerName>
    <manufacturerSrn>CH-MF-000041543</manufacturerSrn>
    <authorisedRepresentativeName>Optima Sanità S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RU600118</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:32:55.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RU600087BU</udiDi>
    <basicUdiDi>B-RU600087BU</basicUdiDi>
    <tradeName>Optrex ACTIMIST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Optima Medical Swiss AG</manufacturerName>
    <manufacturerSrn>CH-MF-000041543</manufacturerSrn>
    <authorisedRepresentativeName>Optima Sanità S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RU600087</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:32:51.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RU600086BS</udiDi>
    <basicUdiDi>B-RU600086BS</basicUdiDi>
    <tradeName>Optrex ACTIMIST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Optima Medical Swiss AG</manufacturerName>
    <manufacturerSrn>CH-MF-000041543</manufacturerSrn>
    <authorisedRepresentativeName>Optima Sanità S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RU600086</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:32:51.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RU600085BQ</udiDi>
    <basicUdiDi>B-RU600085BQ</basicUdiDi>
    <tradeName>Optrex ACTIMIST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Optima Medical Swiss AG</manufacturerName>
    <manufacturerSrn>CH-MF-000041543</manufacturerSrn>
    <authorisedRepresentativeName>Optima Sanità S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RU600085</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:32:50.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RU600083BL</udiDi>
    <basicUdiDi>B-RU600083BL</basicUdiDi>
    <tradeName>Optrex ACTIMIST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Optima Medical Swiss AG</manufacturerName>
    <manufacturerSrn>CH-MF-000041543</manufacturerSrn>
    <authorisedRepresentativeName>Optima Sanità S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RU600083</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:32:49.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RU600081BG</udiDi>
    <basicUdiDi>B-RU600081BG</basicUdiDi>
    <tradeName>Optrex ACTIMIST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Optima Medical Swiss AG</manufacturerName>
    <manufacturerSrn>CH-MF-000041543</manufacturerSrn>
    <authorisedRepresentativeName>Optima Sanità S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RU600081</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:32:45.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560323641176</udiDi>
    <basicUdiDi>4560323640018B</basicUdiDi>
    <tradeName>Slit Lamp Microscopes 30GL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Takagi seiko</manufacturerName>
    <manufacturerSrn>JP-MF-000008791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30GL</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:56:53.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332343301586</udiDi>
    <basicUdiDi>7332343200027F</basicUdiDi>
    <tradeName>MEDIC EYE WASH Spray, 50 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aurena Laboratories AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002890</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301535</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T07:57:46.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PF00258KY</udiDi>
    <basicUdiDi>B-PF00258KY</basicUdiDi>
    <tradeName>OFTAROS SAGGIO</tradeName>
    <deviceName>OFTAROS SAGGIO</deviceName>
    <manufacturerName>STAROS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000052612</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF00258</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:43:05.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PF00204K9</udiDi>
    <basicUdiDi>B-PF00204K9</basicUdiDi>
    <tradeName>OFTAROS</tradeName>
    <deviceName>OFTAROS</deviceName>
    <manufacturerName>STAROS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000052612</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF00204</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:43:04.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380651000063</udiDi>
    <basicUdiDi>038065GMN000035GW</basicUdiDi>
    <tradeName>I-Spear</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alcon Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016248</manufacturerSrn>
    <authorisedRepresentativeName>Alcon Laboratories Belgium</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014721</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8065100006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:45:53.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380651000100</udiDi>
    <basicUdiDi>038065GMN000035GW</basicUdiDi>
    <tradeName>I-Spear</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alcon Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016248</manufacturerSrn>
    <authorisedRepresentativeName>Alcon Laboratories Belgium</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014721</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8065100010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:45:53.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OPTOMD7101YN</udiDi>
    <basicUdiDi>B-OPTOMD7101YN</basicUdiDi>
    <tradeName>OPTONIC B5 GEL</tradeName>
    <deviceName>OPTONIC B5 GEL</deviceName>
    <manufacturerName>IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.</manufacturerName>
    <manufacturerSrn>GR-MF-000032958</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPTONIC B5 GEL</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:15:28.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OPTOMD4402YJ</udiDi>
    <basicUdiDi>B-OPTOMD4402YJ</basicUdiDi>
    <tradeName>OPTOFRESH EYELID CLEANSER</tradeName>
    <deviceName>OPTOFRESH EYELID CLEANSER</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>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPTOFRESH EYELID CLEANSER</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:15:23.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OPTOMD2801YN</udiDi>
    <basicUdiDi>B-OPTOMD2801YN</basicUdiDi>
    <tradeName>OPTONIC</tradeName>
    <deviceName>OPTONIC</deviceName>
    <manufacturerName>IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.</manufacturerName>
    <manufacturerSrn>GR-MF-000032958</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPTONIC</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:15:22.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OPTOMD2701YH</udiDi>
    <basicUdiDi>B-OPTOMD2701YH</basicUdiDi>
    <tradeName>OPTOFRESH</tradeName>
    <deviceName>OPTOFRESH</deviceName>
    <manufacturerName>IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.</manufacturerName>
    <manufacturerSrn>GR-MF-000032958</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPTOFRESH</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:15:21.702Z</lastUpdated>
  </row>
</eudamedExport>