<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-JPMF3928_405089701FZ</udiDi>
    <basicUdiDi>B-JPMF3928_405089701FZ</basicUdiDi>
    <tradeName>NON-MYDRIATIC RETINAL CAMERA TRC-NW8</tradeName>
    <deviceName>NON-MYDRIATIC RETINAL CAMERA TRC-NW8</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>MDD</legislation>
    <emdnCode>Z12120105</emdnCode>
    <emdnDescription>FLUOROANGIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>405089701</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:24:37.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JPMF3928_1037591-03YH</udiDi>
    <basicUdiDi>B-JPMF3928_1037591-03YH</basicUdiDi>
    <tradeName>REFRACTION SYSTEM Chronos</tradeName>
    <deviceName>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>MDD</legislation>
    <emdnCode>Z12120115</emdnCode>
    <emdnDescription>OPTOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1037591-03</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:24:37.003Z</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>D-HX001VW</udiDi>
    <basicUdiDi>B-HX001VW</basicUdiDi>
    <tradeName>Precisio</tradeName>
    <deviceName>Precisio</deviceName>
    <manufacturerName>iVis Technologies S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000016859</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HX001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:38.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ESMF000024270OPTODES1MH</udiDi>
    <basicUdiDi>B-ESMF000024270OPTODES1MH</basicUdiDi>
    <tradeName>DALTE</tradeName>
    <deviceName>OPTOTIPO CON DESLUMBRÓMETRO</deviceName>
    <manufacturerName>MNM INGENIERIA SCA</manufacturerName>
    <manufacturerSrn>ES-MF-000024270</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPTODES1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:02:31.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ESMF000024270DTSENSI1GP</udiDi>
    <basicUdiDi>B-ESMF000024270DTSENSI1GP</basicUdiDi>
    <tradeName>DALTE</tradeName>
    <deviceName>TEST DE SENSIBILIDAD AL CONTRASTE</deviceName>
    <manufacturerName>MNM INGENIERIA SCA</manufacturerName>
    <manufacturerSrn>ES-MF-000024270</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSENSI1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:02:30.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ESMF000024270CAMPIME14X</udiDi>
    <basicUdiDi>B-ESMF000024270CAMPIME14X</basicUdiDi>
    <tradeName>DALTE</tradeName>
    <deviceName>PANTALLA TANGENTE PARA DIAGNÓSTICO DEL CAMPO VISUAL</deviceName>
    <manufacturerName>MNM INGENIERIA SCA</manufacturerName>
    <manufacturerSrn>ES-MF-000024270</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAMPIME1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:02:27.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ENTstatistics-5.1.19MA</udiDi>
    <basicUdiDi>B-ENTstatistics-5.1.19MA</basicUdiDi>
    <tradeName>D-ENTstatistics-5.1.19MA</tradeName>
    <deviceName>ENTstatistics</deviceName>
    <manufacturerName>Innoforce Anstalt</manufacturerName>
    <manufacturerSrn>LI-MF-000002047</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12129092</emdnCode>
    <emdnDescription>VARIOUS OPHTALMOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENTstatistics 5.1.19</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T17:44:27.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ENTstatistics-5.1.18M8</udiDi>
    <basicUdiDi>B-ENTstatistics-5.1.18M8</basicUdiDi>
    <tradeName>D-ENTstatistics-5.1.18M8</tradeName>
    <deviceName>ENTstatistics</deviceName>
    <manufacturerName>Innoforce Anstalt</manufacturerName>
    <manufacturerSrn>LI-MF-000002047</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12129092</emdnCode>
    <emdnDescription>VARIOUS OPHTALMOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENTstatistics 5.1.18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T17:44:26.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECM-5.1.186N</udiDi>
    <basicUdiDi>B-ECM-5.1.186N</basicUdiDi>
    <tradeName>D-ECM-5.1.186N</tradeName>
    <deviceName>Eye Clinic Manager</deviceName>
    <manufacturerName>Innoforce Anstalt</manufacturerName>
    <manufacturerSrn>LI-MF-000002047</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12129092</emdnCode>
    <emdnDescription>VARIOUS OPHTALMOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECM 5.1.18</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:43.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DX001UJ</udiDi>
    <basicUdiDi>B-DX001UJ</basicUdiDi>
    <tradeName>pMetrics</tradeName>
    <deviceName>pMetrics</deviceName>
    <manufacturerName>iVis Technologies S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000016859</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:18:25.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BNOMF000040782001S9</udiDi>
    <basicUdiDi>B-BNOMF000040782001S9</basicUdiDi>
    <tradeName>BulbiCAM</tradeName>
    <deviceName>BulbiCAM</deviceName>
    <manufacturerName>Bulbitech AS</manufacturerName>
    <manufacturerSrn>NO-MF-000040782</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:28:20.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A1021KD</udiDi>
    <basicUdiDi>B-A1021KD</basicUdiDi>
    <tradeName>P200, P200Dx</tradeName>
    <deviceName>Panoramic Ophthalmoscope 200</deviceName>
    <manufacturerName>Optos plc</manufacturerName>
    <manufacturerSrn>GB-MF-000019460</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120114</emdnCode>
    <emdnDescription>OPHTHALMOSCOPES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>A1021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:15:31.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A10022RU</udiDi>
    <basicUdiDi>B-A10022RU</basicUdiDi>
    <tradeName>P200MA</tradeName>
    <deviceName>Panoramic Ophthalmoscope 200MA</deviceName>
    <manufacturerName>Optos plc</manufacturerName>
    <manufacturerSrn>GB-MF-000019460</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120114</emdnCode>
    <emdnDescription>OPHTHALMOSCOPES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>A10022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:15:31.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A10021RS</udiDi>
    <basicUdiDi>B-A10021RS</basicUdiDi>
    <tradeName>P200C</tradeName>
    <deviceName>Panoramic Ophthalmoscope 200C</deviceName>
    <manufacturerName>Optos plc</manufacturerName>
    <manufacturerSrn>GB-MF-000019460</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120114</emdnCode>
    <emdnDescription>OPHTHALMOSCOPES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>A10021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:15:25.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84370263851014VN7</udiDi>
    <basicUdiDi>B-84370263851014VN7</basicUdiDi>
    <tradeName>OPTOMEP</tradeName>
    <deviceName>OPTOMEP</deviceName>
    <manufacturerName>SMT4V RESEARCHING SL</manufacturerName>
    <manufacturerSrn>ES-MF-000042932</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1212012092</emdnCode>
    <emdnDescription>INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:16:06.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-805669782TL</udiDi>
    <basicUdiDi>B-805669782TL</basicUdiDi>
    <tradeName>REXON-EYE</tradeName>
    <deviceName>REXON-EYE</deviceName>
    <manufacturerName>Resono Ophthalmic</manufacturerName>
    <manufacturerSrn>IT-MF-000019770</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4001007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:48:18.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4602122003158MM4H</udiDi>
    <basicUdiDi>B-4602122003158MM4H</basicUdiDi>
    <tradeName>EASYTON</tradeName>
    <deviceName>Easyton</deviceName>
    <manufacturerName>Yelatma Instrument-Making Enterprise Joint-Stock Company</manufacturerName>
    <manufacturerSrn>RU-MF-000008411</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120122</emdnCode>
    <emdnDescription>TONOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11782</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:51:40.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>42624749300045</udiDi>
    <basicUdiDi>B-42624749300045</basicUdiDi>
    <tradeName>Lens Reviewer</tradeName>
    <deviceName>Lens Reviewer</deviceName>
    <manufacturerName>AkknaTek</manufacturerName>
    <manufacturerSrn>DE-MF-000025855</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120113</emdnCode>
    <emdnDescription>OPHTHALMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LR04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:42:10.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240011065</udiDi>
    <basicUdiDi>880924001PRKNW</basicUdiDi>
    <tradeName>08809240011065</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTHALMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRK-6000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T14:47:12.865Z</lastUpdated>
  </row>
</eudamedExport>