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    <basicUdiDi>4560126260080UF</basicUdiDi>
    <tradeName>OPHTHALMIC DATA SYSTEM IMAGEnet 7</tradeName>
    <deviceName>OPHTHALMIC DATA SYSTEM</deviceName>
    <manufacturerName>TOPCON CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000003928</manufacturerSrn>
    <authorisedRepresentativeName>Topcon Europe Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000441</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>IMAGEnet 7</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:58:12.003Z</lastUpdated>
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    <udiDi>04560126268860</udiDi>
    <basicUdiDi>4560126260010TS</basicUdiDi>
    <tradeName>AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA</tradeName>
    <deviceName>AUTO KERATO-REFRACTO TONOMETER</deviceName>
    <manufacturerName>TOPCON CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000003928</manufacturerSrn>
    <authorisedRepresentativeName>Topcon Europe Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000441</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120122</emdnCode>
    <emdnDescription>TONOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRK-3 OMNIA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:58:08.001Z</lastUpdated>
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    <udiDi>04560126268563</udiDi>
    <basicUdiDi>4560126260111TZ</basicUdiDi>
    <tradeName>04560126268563</tradeName>
    <deviceName>Optional Accessory for COMPU VISION CV-5000</deviceName>
    <manufacturerName>TOPCON CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000003928</manufacturerSrn>
    <authorisedRepresentativeName>Topcon Europe Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000441</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 DIAL CONTROLLER KB-50S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:58:07.249Z</lastUpdated>
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    <udiDi>04560126268518</udiDi>
    <basicUdiDi>4560126260110TX</basicUdiDi>
    <tradeName>COMPU VISION CV-5000</tradeName>
    <deviceName>COMPU VISION / VISION TESTER</deviceName>
    <manufacturerName>TOPCON CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000003928</manufacturerSrn>
    <authorisedRepresentativeName>Topcon Europe Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000441</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV-5000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:58:06.404Z</lastUpdated>
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    <udiDi>04560126268341</udiDi>
    <basicUdiDi>4560126260500UG</basicUdiDi>
    <tradeName>REFRACTION SYSTEM Chronos</tradeName>
    <deviceName>Chronos</deviceName>
    <manufacturerName>TOPCON CORPORATION</manufacturerName>
    <manufacturerSrn>JP-PR-000041957</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120115</emdnCode>
    <emdnDescription>OPTOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Chronos</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:58:05.600Z</lastUpdated>
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    <udiDi>04560126268303</udiDi>
    <basicUdiDi>4560126260040U3</basicUdiDi>
    <tradeName>3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton2</tradeName>
    <deviceName>3D Optical Coherence Tomography</deviceName>
    <manufacturerName>TOPCON CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000003928</manufacturerSrn>
    <authorisedRepresentativeName>Topcon Europe Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000441</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120121</emdnCode>
    <emdnDescription>OPTICAL CONSISTENCY TOMOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRI OCT Triton2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:58:01.610Z</lastUpdated>
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    <udiDi>04560126268204</udiDi>
    <basicUdiDi>4560126260020TV</basicUdiDi>
    <tradeName>NON-MYDRIATIC RETINAL CAMERA NW500</tradeName>
    <deviceName>RETINAL CAMERA</deviceName>
    <manufacturerName>TOPCON CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000003928</manufacturerSrn>
    <authorisedRepresentativeName>Topcon Europe Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000441</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120105</emdnCode>
    <emdnDescription>FLUOROANGIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NW500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:58:00.804Z</lastUpdated>
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    <udiDi>04560126268198</udiDi>
    <basicUdiDi>4560126260061UB</basicUdiDi>
    <tradeName>Chinrest CRX-1000 for REFRACTION SYSTEM Chronos</tradeName>
    <deviceName>Optional Accessories for REFRACTION SYSTEM Chronos</deviceName>
    <manufacturerName>TOPCON CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000003928</manufacturerSrn>
    <authorisedRepresentativeName>Topcon Europe Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000441</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120115</emdnCode>
    <emdnDescription>OPTOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRX-1000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:58:00.040Z</lastUpdated>
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    <udiDi>04560126268174</udiDi>
    <basicUdiDi>4560126260060U9</basicUdiDi>
    <tradeName>REFRACTION SYSTEM Chronos</tradeName>
    <deviceName>AUTO KERATO-REFRACTOMETER</deviceName>
    <manufacturerName>TOPCON CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000003928</manufacturerSrn>
    <authorisedRepresentativeName>Topcon Europe Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000441</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120115</emdnCode>
    <emdnDescription>OPTOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Chronos</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:57:59.342Z</lastUpdated>
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    <udiDi>04560126268150</udiDi>
    <basicUdiDi>4560126260030TY</basicUdiDi>
    <tradeName>COMPUTERIZED TONOMETER　CT-800</tradeName>
    <deviceName>COMPUTERIZED TONOMETER</deviceName>
    <manufacturerName>TOPCON CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000003928</manufacturerSrn>
    <authorisedRepresentativeName>Topcon Europe Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000441</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120122</emdnCode>
    <emdnDescription>TONOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT-800</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:57:55.218Z</lastUpdated>
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    <udiDi>04549292228489</udiDi>
    <basicUdiDi>4549292rc01DK</basicUdiDi>
    <tradeName>Digital Retinal Camera CR-10</tradeName>
    <deviceName>CR-10</deviceName>
    <manufacturerName>Canon Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000013254</manufacturerSrn>
    <authorisedRepresentativeName>Canon Medical Systems Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010531</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120114</emdnCode>
    <emdnDescription>OPHTHALMOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT8-2172</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:56:35.095Z</lastUpdated>
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    <udiDi>04549292214802</udiDi>
    <basicUdiDi>4549292rk01ET</basicUdiDi>
    <tradeName>Full Auto Ref-Keratometer RK-F3m</tradeName>
    <deviceName>RK-F3m</deviceName>
    <manufacturerName>Canon Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000013254</manufacturerSrn>
    <authorisedRepresentativeName>Canon Medical Systems Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010531</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120113</emdnCode>
    <emdnDescription>OPHTHALMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB-A20A-B009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:56:34.306Z</lastUpdated>
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    <udiDi>04549292147216</udiDi>
    <basicUdiDi>4549292oc01CW</basicUdiDi>
    <tradeName>Optical Coherence Tomography OCT-A1</tradeName>
    <deviceName>OCT-R1</deviceName>
    <manufacturerName>Canon Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000013254</manufacturerSrn>
    <authorisedRepresentativeName>Canon Medical Systems Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010531</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120113</emdnCode>
    <emdnDescription>OPHTHALMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT8-1835</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:56:29.502Z</lastUpdated>
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    <udiDi>04549292084696</udiDi>
    <basicUdiDi>4549292es01D8</basicUdiDi>
    <tradeName>Ophthalmic Software Platform RX(RX Capture for Retinal Camera, RX Server, RX Viewer)</tradeName>
    <deviceName>Ophthalmic Software Platform RX</deviceName>
    <manufacturerName>Canon Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000013254</manufacturerSrn>
    <authorisedRepresentativeName>Canon Medical Systems Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010531</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>BT8-1836</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:56:27.923Z</lastUpdated>
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    <udiDi>04549292074376</udiDi>
    <basicUdiDi>4549292to01FV</basicUdiDi>
    <tradeName>Full Auto Tonometer TX-20P</tradeName>
    <deviceName>TX-20P</deviceName>
    <manufacturerName>Canon Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000013254</manufacturerSrn>
    <authorisedRepresentativeName>Canon Medical Systems Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010531</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120122</emdnCode>
    <emdnDescription>TONOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT8-2590</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:56:27.111Z</lastUpdated>
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    <udiDi>04540008310627</udiDi>
    <basicUdiDi>45400080000837</basicUdiDi>
    <tradeName>SLIT LAMP RS-5000</tradeName>
    <deviceName>SLIT LAMP RS-5000</deviceName>
    <manufacturerName>Rexxam Co.,Ltd. Kagawa Factory</manufacturerName>
    <manufacturerSrn>JP-MF-000004361</manufacturerSrn>
    <authorisedRepresentativeName>Rexxam Co., Ltd. Netherlands Office</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002643</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120108</emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS303</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:51:45.926Z</lastUpdated>
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    <udiDi>04262451050003</udiDi>
    <basicUdiDi>426245105PasKalSD</basicUdiDi>
    <tradeName>PASKAL 3D</tradeName>
    <deviceName>Sehzeichenprojektor PASKAL 3D Erlebnisrefraktion</deviceName>
    <manufacturerName>EVEX Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037933</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PASKAL 3D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:37:06.778Z</lastUpdated>
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    <udiDi>04262388710247</udiDi>
    <basicUdiDi>426238871T21023K</basicUdiDi>
    <tradeName>Merlin</tradeName>
    <deviceName>Typ2102</deviceName>
    <manufacturerName>Zeisberg GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120124</emdnCode>
    <emdnDescription>VIDEO/ELECTRONYSTAGMOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP30.AR01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:24:12.481Z</lastUpdated>
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    <udiDi>04260381965008</udiDi>
    <basicUdiDi>426038196WandstationSC</basicUdiDi>
    <tradeName>wall diagnostic center with otoscope and ophthalmoscope</tradeName>
    <deviceName>wall diagnostic center</deviceName>
    <manufacturerName>Luxamed GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120114</emdnCode>
    <emdnDescription>OPHTHALMOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W1.336.114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:57:18.067Z</lastUpdated>
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    <udiDi>04260381964315</udiDi>
    <basicUdiDi>426038196OphthalmoskopZH</basicUdiDi>
    <tradeName>LuxaScope Oculus</tradeName>
    <deviceName>LuxaScope Oculus LED</deviceName>
    <manufacturerName>Luxamed GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120114</emdnCode>
    <emdnDescription>OPHTHALMOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F1.416.114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:54:58.905Z</lastUpdated>
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