<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04049584005717</udiDi>
    <basicUdiDi>404958416PY</basicUdiDi>
    <tradeName>Universal-Messbrille UB 4</tradeName>
    <deviceName>Manuelle Refraktion</deviceName>
    <manufacturerName>OCULUS Optikgeräte GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212012099</emdnCode>
    <emdnDescription>INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:30:00.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049584005656</udiDi>
    <basicUdiDi>404958427Q5</basicUdiDi>
    <tradeName>Praxisbrille für Kinder mit fester Nasenauflage</tradeName>
    <deviceName>Praxisbrillen</deviceName>
    <manufacturerName>OCULUS Optikgeräte GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212012099</emdnCode>
    <emdnDescription>INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42480</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:29:59.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049584001153</udiDi>
    <basicUdiDi>404958429Q9</basicUdiDi>
    <tradeName>Prismengläserkasten S, vergütet</tradeName>
    <deviceName>Messgläser</deviceName>
    <manufacturerName>OCULUS Optikgeräte GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212012080</emdnCode>
    <emdnDescription>INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:29:56.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049368226178</udiDi>
    <basicUdiDi>4049368200BPL</basicUdiDi>
    <tradeName>04049368226178</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Geuder AG</manufacturerName>
    <manufacturerSrn>DE-MF-000008044</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1212020780</emdnCode>
    <emdnDescription>PHACO-VITRECTOMY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-90030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:29:54.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049368226000</udiDi>
    <basicUdiDi>4049368200APJ</basicUdiDi>
    <tradeName>04049368226000</tradeName>
    <deviceName>VIVOS device system</deviceName>
    <manufacturerName>Geuder AG</manufacturerName>
    <manufacturerSrn>DE-MF-000008044</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212020702</emdnCode>
    <emdnDescription>PHACO-VITRECTOMY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-90001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:29:48.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065600007</udiDi>
    <basicUdiDi>08800065600007H6</basicUdiDi>
    <tradeName>nun</tradeName>
    <deviceName>Ophthalmoscope</deviceName>
    <manufacturerName>WikiOptics Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026369</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120114</emdnCode>
    <emdnDescription>OPHTHALMOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08800065600007</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:05:32.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850062486027</udiDi>
    <basicUdiDi>08677440001ALLYUN</basicUdiDi>
    <tradeName>Patient Interface Device</tradeName>
    <deviceName>ALLY Adaptive Cataract Treatment System</deviceName>
    <manufacturerName>LENSAR</manufacturerName>
    <manufacturerSrn>US-MF-000008522</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120285</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70-00036-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:58:32.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>08600098265101</udiDi>
    <basicUdiDi>08600098265MacEx5N</basicUdiDi>
    <tradeName>Macula Explorer</tradeName>
    <deviceName>Macula Explorer</deviceName>
    <manufacturerName>Altris Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000043686</manufacturerSrn>
    <authorisedRepresentativeName>ALTRIS EUROPE, SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043669</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120282</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:56:50.850Z</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>00860009826502</udiDi>
    <basicUdiDi>0860009826527W</basicUdiDi>
    <tradeName>Altris</tradeName>
    <deviceName>Altris AI</deviceName>
    <manufacturerName>Altris Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000043686</manufacturerSrn>
    <authorisedRepresentativeName>ALTRIS EUROPE, SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043669</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120182</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:52:58.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858848006773</udiDi>
    <basicUdiDi>085884800677383</basicUdiDi>
    <tradeName>iVue 80</tradeName>
    <deviceName>iVue</deviceName>
    <manufacturerName>Optovue, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000018369</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120121</emdnCode>
    <emdnDescription>OPTICAL CONSISTENCY TOMOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iVue 100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:49:03.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858848006261</udiDi>
    <basicUdiDi>08588480068037K</basicUdiDi>
    <tradeName>Solix Essential</tradeName>
    <deviceName>Solix</deviceName>
    <manufacturerName>Optovue, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000018369</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120121</emdnCode>
    <emdnDescription>OPTICAL CONSISTENCY TOMOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Solix Essential</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:49:02.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850088816006</udiDi>
    <basicUdiDi>08600075895VAC26757E</basicUdiDi>
    <tradeName>00850088816006</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vision Assessment Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000047190</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:48:58.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858848006766</udiDi>
    <basicUdiDi>085884800676686</basicUdiDi>
    <tradeName>iVue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Optovue, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000018369</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12120121</emdnCode>
    <emdnDescription>OPTICAL CONSISTENCY TOMOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iVue 100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:43:09.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840311346271</udiDi>
    <basicUdiDi>08415421OCOSJZ</basicUdiDi>
    <tradeName>ICL/TICL Calculation / Implantation Orientation Diagram (IOD) Software</tradeName>
    <deviceName>ICL/TICL Calculation Software</deviceName>
    <manufacturerName>STAAR Surgical AG</manufacturerName>
    <manufacturerSrn>CH-MF-000039544</manufacturerSrn>
    <authorisedRepresentativeName>STAAR Surgical AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000025479</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12129082</emdnCode>
    <emdnDescription>VARIOUS OPHTALMOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICL/TICL Calculation / Implantation Orientation Diagram (IOD) Software</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:08:51.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813125015428</udiDi>
    <basicUdiDi>081312501LIO9E</basicUdiDi>
    <tradeName>PASCAL LIO</tradeName>
    <deviceName>Laser Indirect Ophthalmoscope (LIO)</deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120114</emdnCode>
    <emdnDescription>OPHTHALMOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-06620</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:16:52.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813125010584</udiDi>
    <basicUdiDi>081312501OMA9D</basicUdiDi>
    <tradeName>OMA (810 nm)</tradeName>
    <deviceName>Operating Microscope Adapter (OMA)</deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>13411</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:16:51.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813125010478</udiDi>
    <basicUdiDi>081312501SLA9W</basicUdiDi>
    <tradeName>SLA Symphony 3 (532 nm &amp; 810 nm)</tradeName>
    <deviceName>Slit Lamp Adapter (SLA)</deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120108</emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31122-02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:16:46.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813125010164</udiDi>
    <basicUdiDi>081312501ESF8P</basicUdiDi>
    <tradeName>Eye Safety Filter, Fixed (810 nm)</tradeName>
    <deviceName>Eye Safety Filter (ESF)</deviceName>
    <manufacturerName>Iridex Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000029814</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>11326</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:16:45.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811286033312</udiDi>
    <basicUdiDi>081128603FluorBulb8X</basicUdiDi>
    <tradeName>Replacement Lamp with Fenestrated Sleeve specifically Calibrated for Precision Vision 2425Ev3 illuminator Cabinets</tradeName>
    <deviceName>Replacement Lamp with Fenestrated Sleeve specifically Calibrated for Precision Vision illuminator Cabinets</deviceName>
    <manufacturerName>Precision Vision, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008456</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212012080</emdnCode>
    <emdnDescription>INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2427D-BI-V3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:58:40.590Z</lastUpdated>
  </row>
</eudamedExport>