<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809240011058</udiDi>
    <basicUdiDi>880924001PRKNW</basicUdiDi>
    <tradeName>08809240011058</tradeName>
    <deviceName>Auto Ref-Keratometer</deviceName>
    <manufacturerName>POTEC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000012281</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</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>PRK-5000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:01:05.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087500286</udiDi>
    <basicUdiDi>69450875600BLE</basicUdiDi>
    <tradeName>Fundus Viewing System</tradeName>
    <deviceName>Fundus Viewing System</deviceName>
    <manufacturerName>Shanghai Mediworks Precision Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004251</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>600B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:04:25.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087500279</udiDi>
    <basicUdiDi>69450875600ALC</basicUdiDi>
    <tradeName>Stereoptic Inverter</tradeName>
    <deviceName>Stereoptic Inverter</deviceName>
    <manufacturerName>Shanghai Mediworks Precision Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004251</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>600A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:04:25.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>05070002498346</udiDi>
    <basicUdiDi>50700024983003DX</basicUdiDi>
    <tradeName>Lumio</tradeName>
    <deviceName>Lumio</deviceName>
    <manufacturerName>Aston Vision Sciences Ltd.</manufacturerName>
    <manufacturerSrn>UK-MF-000038786</manufacturerSrn>
    <authorisedRepresentativeName>Eclipse Medtech Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000037925</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>003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:19:56.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272706773</udiDi>
    <basicUdiDi>50552727AmslerGridH7</basicUdiDi>
    <tradeName>Amsler Chart (Pad of 50)</tradeName>
    <deviceName>Amsler Grid</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>2215-P-7057</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:08:54.926Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>04719872711025</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 DEA 100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:35:56.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872711018</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 DEC 100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:35:53.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250668607219</udiDi>
    <basicUdiDi>42506686-B01-VCR500S-5K</basicUdiDi>
    <tradeName>VISUCORE 500 System</tradeName>
    <deviceName>VISUCORE 500 System</deviceName>
    <manufacturerName>Carl Zeiss Vision GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000040411</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>000000-2548-409</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:43:24.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250668607202</udiDi>
    <basicUdiDi>42506686-B01-VR600-87</basicUdiDi>
    <tradeName>VISUREF 600</tradeName>
    <deviceName>VISUREF 600</deviceName>
    <manufacturerName>Carl Zeiss Vision GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>000000-2572-424</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:43:22.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250668606052</udiDi>
    <basicUdiDi>42506686-B01-VCR500R-5G</basicUdiDi>
    <tradeName>VISUCORE 500 Refractor</tradeName>
    <deviceName>VISUCORE 500 Refractor</deviceName>
    <manufacturerName>Carl Zeiss Vision GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006173</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>000000-2522-537</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:43:07.691Z</lastUpdated>
  </row>
</eudamedExport>