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    <udiDi>05055272720885</udiDi>
    <basicUdiDi>50552727VisionTestChartA3</basicUdiDi>
    <tradeName>Peter Rabbit Test</tradeName>
    <deviceName>Vision testing/training chart</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</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>2205-L-1004</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:08:54.158Z</lastUpdated>
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    <udiDi>05055272701532</udiDi>
    <basicUdiDi>50552727RETINOSCOPESD7</basicUdiDi>
    <tradeName>2.8V SPOT MAGNETIC RET</tradeName>
    <deviceName>Retinoscope</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120118</emdnCode>
    <emdnDescription>RETINOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1302-P-1004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:08:48.511Z</lastUpdated>
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    <udiDi>05055272701204</udiDi>
    <basicUdiDi>50552727INDOSCOPES5Q</basicUdiDi>
    <tradeName>API 2/2 IN CARTON</tradeName>
    <deviceName>Indirect Ophthalmoscope</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120114</emdnCode>
    <emdnDescription>OPHTHALMOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1204-P-3036</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:08:33.134Z</lastUpdated>
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    <udiDi>05055272700641</udiDi>
    <basicUdiDi>5055272745084XR</basicUdiDi>
    <tradeName>POCKET SET 2.8V</tradeName>
    <deviceName>Ophthalmic/otologic diagnostic set</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</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>1102-P-1041</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:08:32.444Z</lastUpdated>
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  <row>
    <udiDi>05055272700634</udiDi>
    <basicUdiDi>50552727OPHTHALMOSCOPES39</basicUdiDi>
    <tradeName>2.8V POCKET OPHTHALMOSCOPE HEAD &amp; BULB</tradeName>
    <deviceName>Ophthalmoscope</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120114</emdnCode>
    <emdnDescription>OPHTHALMOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1102-P-1033</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:08:20.281Z</lastUpdated>
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  <row>
    <udiDi>05050474617193</udiDi>
    <basicUdiDi>5050474a000079E</basicUdiDi>
    <tradeName>PATIENT CHAIR</tradeName>
    <deviceName>CATALYS PATIENT CHAIR</deviceName>
    <manufacturerName>AMO Manufacturing USA, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023322</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120280</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0160-6030</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:58:38.912Z</lastUpdated>
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  <row>
    <udiDi>05050474604797</udiDi>
    <basicUdiDi>5050474a000089G</basicUdiDi>
    <tradeName>CATALYS PRECISION LASER SYSTEM</tradeName>
    <deviceName>CATALYS SYSTEM</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>MDR 2017/745</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CATALYS-I</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:58:34.107Z</lastUpdated>
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  <row>
    <udiDi>04987669101773</udiDi>
    <basicUdiDi>4987669221G8</basicUdiDi>
    <tradeName>OPHTHALMIC SURGICAL SYSTEM CV-30000</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>Z1212020785</emdnCode>
    <emdnDescription>PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fortas_B01E007</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:43:28.791Z</lastUpdated>
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  <row>
    <udiDi>04987669203552</udiDi>
    <basicUdiDi>4987669233GF</basicUdiDi>
    <tradeName>Fully Assisted Refraction System FARS</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>Z12129092</emdnCode>
    <emdnDescription>VARIOUS OPHTALMOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTP15-0A40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:43:27.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101711</udiDi>
    <basicUdiDi>4987669103FZ</basicUdiDi>
    <tradeName>REFRACTOR RT-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>MDR 2017/745</legislation>
    <emdnCode>Z12120115</emdnCode>
    <emdnDescription>OPTOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33863-0040</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:43:11.765Z</lastUpdated>
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  <row>
    <udiDi>04987669101674</udiDi>
    <basicUdiDi>4987669207GE</basicUdiDi>
    <tradeName>AUTO REF/KERATO/TONO/PACHYMETER TONOREF 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>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:43:10.164Z</lastUpdated>
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  <row>
    <udiDi>04987669101667</udiDi>
    <basicUdiDi>4987669204G8</basicUdiDi>
    <tradeName>NONCONTACT TONO/PACHYMETER NT-530P</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>B01E012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:43:07.765Z</lastUpdated>
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  <row>
    <udiDi>04987669101643</udiDi>
    <basicUdiDi>4987669217GH</basicUdiDi>
    <tradeName>Image Filing Software NAVIS-EX</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>Z12120192</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19702-0040</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:43:06.171Z</lastUpdated>
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    <udiDi>04987669101629</udiDi>
    <basicUdiDi>4987669222GA</basicUdiDi>
    <tradeName>OPHTHALMIC SURGICAL SYSTEM CV-9000R</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>Z1212020785</emdnCode>
    <emdnDescription>PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cubeα_B01E001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:43:05.377Z</lastUpdated>
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    <udiDi>04987669101582</udiDi>
    <basicUdiDi>4987669212G7</basicUdiDi>
    <tradeName>GONIOSCOPE GS-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>Z12120114</emdnCode>
    <emdnDescription>OPHTHALMOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:43:03.774Z</lastUpdated>
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    <udiDi>04987669101483</udiDi>
    <basicUdiDi>4987669102FX</basicUdiDi>
    <tradeName>System Table ST-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>MDR 2017/745</legislation>
    <emdnCode>Z12129001</emdnCode>
    <emdnDescription>OPHTHALMOLOGICAL INSTRUMENT STANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36301-0P41,36301-0T41</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:43:01.397Z</lastUpdated>
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    <udiDi>04987669101377</udiDi>
    <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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