<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07640486840856</udiDi>
    <basicUdiDi>764048684Discovery18091G4</basicUdiDi>
    <tradeName>07640486840856</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ikerian AG</manufacturerName>
    <manufacturerSrn>CH-MF-000014537</manufacturerSrn>
    <authorisedRepresentativeName>Blue Broccoli GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LI-AR-000000233</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12120192</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>07640486840856</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:04:51.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640486840023</udiDi>
    <basicUdiDi>764048684Layer200412M</basicUdiDi>
    <tradeName>Retinai Layer Segmentation</tradeName>
    <deviceName>RetinAI Layer Segmentation</deviceName>
    <manufacturerName>Ikerian AG</manufacturerName>
    <manufacturerSrn>CH-MF-000014537</manufacturerSrn>
    <authorisedRepresentativeName>Blue Broccoli GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LI-AR-000000233</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120192</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>7640486840023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:04:50.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640486840016</udiDi>
    <basicUdiDi>764048684Fluid20042X5</basicUdiDi>
    <tradeName>07640486840016</tradeName>
    <deviceName>RetinAI Fluid Segmentation</deviceName>
    <manufacturerName>Ikerian AG</manufacturerName>
    <manufacturerSrn>CH-MF-000014537</manufacturerSrn>
    <authorisedRepresentativeName>Blue Broccoli GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LI-AR-000000233</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120192</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>7640486840016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:04:49.845Z</lastUpdated>
  </row>
  <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>
  </row>
  <row>
    <udiDi>04560126268976</udiDi>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>07640486840047</udiDi>
    <basicUdiDi>764048684Discovery18091G4</basicUdiDi>
    <tradeName>Retinai Discovery</tradeName>
    <deviceName>RetinAI Discovery</deviceName>
    <manufacturerName>Ikerian AG</manufacturerName>
    <manufacturerSrn>CH-MF-000014537</manufacturerSrn>
    <authorisedRepresentativeName>Blue Broccoli GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LI-AR-000000233</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>7640486840047</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:49:35.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JPMF3928_1036133-01UL</udiDi>
    <basicUdiDi>B-JPMF3928_1036133-01UL</basicUdiDi>
    <tradeName>OPHTHALMIC DATA SYSTEM IMAGEnet 6</tradeName>
    <deviceName>OPHTHALMIC DATA SYSTEM IMAGEnet 6</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>MDD</legislation>
    <emdnCode>Z12120192</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1036133-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:07:10.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860011973201</udiDi>
    <basicUdiDi>08600119732APVN</basicUdiDi>
    <tradeName>Assure Plus</tradeName>
    <deviceName>Assure Plus</deviceName>
    <manufacturerName>Eyetelligence Pty Ltd, an Optain Health Company</manufacturerName>
    <manufacturerSrn>AU-MF-000044109</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>Assure Plus 1.0.0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:53:52.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITOS-standaloneXB</udiDi>
    <basicUdiDi>B-ITOS-standaloneXB</basicUdiDi>
    <tradeName>D-ITOS-standaloneXB</tradeName>
    <deviceName>ITOS standalone</deviceName>
    <manufacturerName>Voigtmann GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120192</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITOS standalone</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:16:11.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860000470018</udiDi>
    <basicUdiDi>B-00860000470018</basicUdiDi>
    <tradeName>EyeArt</tradeName>
    <deviceName>EyeArt</deviceName>
    <manufacturerName>Eyenuk, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000004180</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120192</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.1.0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:44:47.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040295122</udiDi>
    <basicUdiDi>B-00850040295122</basicUdiDi>
    <tradeName>M&amp;S Technologies Smart System® Virtual Reality Headset System</tradeName>
    <deviceName>M&amp;S Technologies Smart System® Virtual Reality Headset System</deviceName>
    <manufacturerName>M&amp;S Technologies</manufacturerName>
    <manufacturerSrn>US-MF-000048924</manufacturerSrn>
    <authorisedRepresentativeName>Certification Company</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120192</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VR-1002H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:21.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045800076</udiDi>
    <basicUdiDi>88000458VFSZ7</basicUdiDi>
    <tradeName>08800045800076</tradeName>
    <deviceName>VUNO Med-Fundus AI</deviceName>
    <manufacturerName>VUNO Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022266</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>VN-M-03</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:24:44.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720299818118</udiDi>
    <basicUdiDi>87202998181EASEEEYEEXAMZ8</basicUdiDi>
    <tradeName>easee online eye exam</tradeName>
    <deviceName>easee online eye exam</deviceName>
    <manufacturerName>easee b.v.</manufacturerName>
    <manufacturerSrn>NL-MF-000021408</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>eo-018</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:53:13.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719333039381</udiDi>
    <basicUdiDi>871933303938RSPLus01EQ</basicUdiDi>
    <tradeName>RS Plus</tradeName>
    <deviceName>RSPlus</deviceName>
    <manufacturerName>IDCP Solutions BV</manufacturerName>
    <manufacturerSrn>NL-MF-000038184</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120192</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS Plus</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:37:18.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683845754011</udiDi>
    <basicUdiDi>8683845754RAI01KF</basicUdiDi>
    <tradeName>Retinow</tradeName>
    <deviceName>Retinow AI (Cloud-based software for diagnosis of retinal disorders)</deviceName>
    <manufacturerName>Retinow Sağlık Teknolojileri ve ARGE Sanayi Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000035284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120192</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RAI01-V01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:16:17.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437024282013</udiDi>
    <basicUdiDi>8437024282ULMASWIAOFT016K</basicUdiDi>
    <tradeName>UMI DR</tradeName>
    <deviceName>UMI DR</deviceName>
    <manufacturerName>ULMA Medical Technologies, S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000019352</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>08437024282013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:13:20.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053610750003</udiDi>
    <basicUdiDi>805361075OPHJW</basicUdiDi>
    <tradeName>Ophthal</tradeName>
    <deviceName>Ophthal</deviceName>
    <manufacturerName>MR DOC S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000027809</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>OPH_IT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:49:01.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640486841211</udiDi>
    <basicUdiDi>764048684Luxia20101BE</basicUdiDi>
    <tradeName>LuxIA</tradeName>
    <deviceName>LuxIA</deviceName>
    <manufacturerName>Ikerian AG</manufacturerName>
    <manufacturerSrn>CH-MF-000014537</manufacturerSrn>
    <authorisedRepresentativeName>Blue Broccoli GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LI-AR-000000233</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120192</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7640486841211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:49:11.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640486841167</udiDi>
    <basicUdiDi>764048684Biomarker20043SV</basicUdiDi>
    <tradeName>RetinAI Macula Biomarkers</tradeName>
    <deviceName>RetinAI Macula Biomarkers</deviceName>
    <manufacturerName>Ikerian AG</manufacturerName>
    <manufacturerSrn>CH-MF-000014537</manufacturerSrn>
    <authorisedRepresentativeName>Blue Broccoli GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LI-AR-000000233</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>7640486841167</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:49:10.273Z</lastUpdated>
  </row>
</eudamedExport>