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<eudamedExport entity="devices">
  <row>
    <udiDi>04987669100851</udiDi>
    <basicUdiDi>4987669220G6</basicUdiDi>
    <tradeName>Green Laser Photocoagulator GYC-500</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER PHOTOCOAGULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101117</udiDi>
    <basicUdiDi>4987669220G6</basicUdiDi>
    <tradeName>Multicolor Laser Photocoagulator MC-500</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER PHOTOCOAGULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E003</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101391</udiDi>
    <basicUdiDi>4987669106G7</basicUdiDi>
    <tradeName>AUTO LENSMETER LM-7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31035-0N40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101407</udiDi>
    <basicUdiDi>4987669106G7</basicUdiDi>
    <tradeName>AUTO LENSMETER LM-7P</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31035-0040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101414</udiDi>
    <basicUdiDi>4987669104G3</basicUdiDi>
    <tradeName>Tabletop Refraction System TS-310</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPTOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS001-0040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101445</udiDi>
    <basicUdiDi>4987669104G3</basicUdiDi>
    <tradeName>REFRACTOR RT-6100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPTOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36301-0M41,36301-0MD1,36301-0Q41,36301-0QD1,36320-0M40,36320-0MD0,RT015-0U40,RT015-0UD0</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101469</udiDi>
    <basicUdiDi>4987669201G2</basicUdiDi>
    <tradeName>AUTO REFRACTOMETER AR-F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30641-0A40,30641-0B40,30641-0C40,30641-0D40,30641-0E40,30641-0F40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101476</udiDi>
    <basicUdiDi>4987669202G4</basicUdiDi>
    <tradeName>AUTO REF/KERATOMETER ARK-F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30741-0A40,30741-0B40,30741-0C40,30741-0D40,30741-0E40,30741-0F40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101490</udiDi>
    <basicUdiDi>4987669102FX</basicUdiDi>
    <tradeName>System Table ST-600</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMOLOGICAL INSTRUMENT STANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36320-0P40</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101568</udiDi>
    <basicUdiDi>4987669216GF</basicUdiDi>
    <tradeName>Scanning Laser Ophthalmoscope Mirante</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR002-0040,SR002-0S40,</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101575</udiDi>
    <basicUdiDi>4987669105G5</basicUdiDi>
    <tradeName>CHART PROJECTOR CP-9</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP009-0CCF,CP009-0G30,CP009-0G60,CP009-0K30,CP009-0M50,CP009-0T30,CP009-0T3F,CP009-0Z30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101681</udiDi>
    <basicUdiDi>4987669101FV</basicUdiDi>
    <tradeName>SLIT LAMP SL-1800</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101698</udiDi>
    <basicUdiDi>4987669101FV</basicUdiDi>
    <tradeName>SLIT LAMP SL-250</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E006</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101704</udiDi>
    <basicUdiDi>4987669101FV</basicUdiDi>
    <tradeName>SLIT LAMP SL-450</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E006</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101766</udiDi>
    <basicUdiDi>4987669222GA</basicUdiDi>
    <tradeName>OPHTHALMIC SURGICAL SYSTEM CV-9000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cubeα_B01E001</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669200650</udiDi>
    <basicUdiDi>4987669101FV</basicUdiDi>
    <tradeName>SLIT LAMP SL-1800</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669200674</udiDi>
    <basicUdiDi>4987669101FV</basicUdiDi>
    <tradeName>SLIT LAMP SL-1800</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669203705</udiDi>
    <basicUdiDi>4987669216GF</basicUdiDi>
    <tradeName>Optical Coherence Tomography RS-1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA002-0040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669609637</udiDi>
    <basicUdiDi>4987669204G8</basicUdiDi>
    <tradeName>NON CONTACT TONO/PACHYMETER NT-1p</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TONOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT-1p/NT-1/NT-1e_B01E001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669609644</udiDi>
    <basicUdiDi>4987669204G8</basicUdiDi>
    <tradeName>NON CONTACT TONO/PACHYMETER NT-1p</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TONOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT-1p/NT-1/NT-1e_B01E001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:21.208Z</lastUpdated>
  </row>
</eudamedExport>