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    <basicUdiDi>4987669101FV</basicUdiDi>
    <tradeName>SLIT LAMP SL-2000</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>MDR 2017/745</legislation>
    <emdnCode>Z12120108</emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E003</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:58.959Z</lastUpdated>
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    <udiDi>04987669101339</udiDi>
    <basicUdiDi>4987669215GD</basicUdiDi>
    <tradeName>Microperimeter MP-3</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>MDR 2017/745</legislation>
    <emdnCode>Z1212012080</emdnCode>
    <emdnDescription>INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16202-0040,16202-0S40</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:57.361Z</lastUpdated>
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    <udiDi>04987669101100</udiDi>
    <basicUdiDi>4987669218GK</basicUdiDi>
    <tradeName>Optical Coherence Tomography RS-330</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>MDR 2017/745</legislation>
    <emdnCode>Z12120121</emdnCode>
    <emdnDescription>OPTICAL CONSISTENCY TOMOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10706-0040, 10706-0F40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:54.161Z</lastUpdated>
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    <udiDi>04987669100813</udiDi>
    <basicUdiDi>4987669104G3</basicUdiDi>
    <tradeName>REFRACTOR RT-3100</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>MDR 2017/745</legislation>
    <emdnCode>Z12120115</emdnCode>
    <emdnDescription>OPTOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34090-0S20,34090-0U20,36301-0N41,36301-0ND1,36301-0S41,36301-0SD1,36320-0N40,36320-0ND0,</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:51.757Z</lastUpdated>
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    <udiDi>04987669100776</udiDi>
    <basicUdiDi>4987669208GG</basicUdiDi>
    <tradeName>REFRACTIVE POWER/CORNEAL ANALYZER OPD-Scan III</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>MDR 2017/745</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E009</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:49.353Z</lastUpdated>
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    <udiDi>04987669100714</udiDi>
    <basicUdiDi>4987669202G4</basicUdiDi>
    <tradeName>AUTO REF/KERATOMETER ARK-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>MDR 2017/745</legislation>
    <emdnCode>Z12120113</emdnCode>
    <emdnDescription>OPHTHALMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30711-0040</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:46.954Z</lastUpdated>
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    <udiDi>04987669100554</udiDi>
    <basicUdiDi>4987669213G9</basicUdiDi>
    <tradeName>Non-Mydriatic Auto Fundus Camera AFC-330</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>MDR 2017/745</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15411-0E00,15411-00B0</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:38.945Z</lastUpdated>
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    <udiDi>04987669100530</udiDi>
    <basicUdiDi>4987669211G5</basicUdiDi>
    <tradeName>SPECULAR MICROSCOPE CEM-530</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>MDR 2017/745</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:36.547Z</lastUpdated>
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  <row>
    <udiDi>04987669100516</udiDi>
    <basicUdiDi>4987669216GF</basicUdiDi>
    <tradeName>Optical Coherence Tomography RS-3000 Advance</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>MDR 2017/745</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10703-0050, 10703-02B0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:34.946Z</lastUpdated>
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  <row>
    <udiDi>04987669100455</udiDi>
    <basicUdiDi>4987669205GA</basicUdiDi>
    <tradeName>US-500 ECHOSCAN</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>MDR 2017/745</legislation>
    <emdnCode>Z12120116</emdnCode>
    <emdnDescription>PACHYMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E012</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:31.745Z</lastUpdated>
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    <udiDi>04987669100424</udiDi>
    <basicUdiDi>4987669203G6</basicUdiDi>
    <tradeName>NON CONTACT TONOMETER NT-510</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>MDR 2017/745</legislation>
    <emdnCode>Z12120122</emdnCode>
    <emdnDescription>TONOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:30.150Z</lastUpdated>
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    <udiDi>04987669100080</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>MDR 2017/745</legislation>
    <emdnCode>Z12120202</emdnCode>
    <emdnDescription>LASER PHOTOCOAGULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B02E002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:28.544Z</lastUpdated>
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    <udiDi>04987669100448</udiDi>
    <basicUdiDi>4987669206GC</basicUdiDi>
    <tradeName>ECHOSCAN US-4000</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>MDR 2017/745</legislation>
    <emdnCode>Z12120116</emdnCode>
    <emdnDescription>PACHYMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E012</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:27.049Z</lastUpdated>
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    <udiDi>04987646810100</udiDi>
    <basicUdiDi>498764681010P6</basicUdiDi>
    <tradeName>04987646810100</tradeName>
    <deviceName>KOWA SL-19</deviceName>
    <manufacturerName>Kowa Company, Ltd. Chofu Factory</manufacturerName>
    <manufacturerSrn>JP-MF-000021126</manufacturerSrn>
    <authorisedRepresentativeName>Kowa Medical Care Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000043041</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120108</emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL191_2491100CO-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:12.494Z</lastUpdated>
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    <udiDi>04987646809531</udiDi>
    <basicUdiDi>498764680953QW</basicUdiDi>
    <tradeName>04987646809531</tradeName>
    <deviceName>KOWA AP-7000</deviceName>
    <manufacturerName>Kowa Company, Ltd. Chofu Factory</manufacturerName>
    <manufacturerSrn>JP-MF-000021126</manufacturerSrn>
    <authorisedRepresentativeName>Kowa Medical Care Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000043041</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT11H_2594CO-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:08.475Z</lastUpdated>
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    <udiDi>04719872710066</udiDi>
    <basicUdiDi>47198727100007L</basicUdiDi>
    <tradeName>MiiS Horus Scope</tradeName>
    <deviceName>Control unit</deviceName>
    <manufacturerName>Medimaging Integrated Solution Inc</manufacturerName>
    <manufacturerSrn>TW-MF-000009317</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MiiS Horus Scope DSC 300</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:01:13.547Z</lastUpdated>
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    <udiDi>04719872711100</udiDi>
    <basicUdiDi>47198727110017V</basicUdiDi>
    <tradeName>MiiS Horus Scope</tradeName>
    <deviceName>Digital Eye Anterior Camera (Lens)</deviceName>
    <manufacturerName>Medimaging Integrated Solution Inc</manufacturerName>
    <manufacturerSrn>TW-MF-000009317</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120108</emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MiiS Horus Scope DEA 200P</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:44:05.585Z</lastUpdated>
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    <udiDi>04719872711056</udiDi>
    <basicUdiDi>47198727110027X</basicUdiDi>
    <tradeName>MiiS Horus Scope</tradeName>
    <deviceName>Digital Eye Anterior Camera (Lens), Digital Eye Surface Camera (Lens)</deviceName>
    <manufacturerName>Medimaging Integrated Solution Inc</manufacturerName>
    <manufacturerSrn>TW-MF-000009317</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MiiS Horus+ Scope DGC 200</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:44:04.789Z</lastUpdated>
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    <udiDi>04719872711032</udiDi>
    <basicUdiDi>47198727110007T</basicUdiDi>
    <tradeName>MiiS Horus Scope</tradeName>
    <deviceName>Digital Eye Fundus Camera (Lens)</deviceName>
    <manufacturerName>Medimaging Integrated Solution Inc</manufacturerName>
    <manufacturerSrn>TW-MF-000009317</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MiiS Horus Scope EEC 100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:44:03.989Z</lastUpdated>
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    <udiDi>04719872710028</udiDi>
    <basicUdiDi>47198727100007L</basicUdiDi>
    <tradeName>MiiS Horus Scope</tradeName>
    <deviceName>Control unit</deviceName>
    <manufacturerName>Medimaging Integrated Solution Inc</manufacturerName>
    <manufacturerSrn>TW-MF-000009317</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MiiS Horus+ Scope DSC 200</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:44:00.006Z</lastUpdated>
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