<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06945087539026</udiDi>
    <basicUdiDi>69450875SlitLamps2C</basicUdiDi>
    <tradeName>Slit Lamp Microscope</tradeName>
    <deviceName></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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12120108</emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945087539026</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:22.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087540022</udiDi>
    <basicUdiDi>69450875SlitLamp2P</basicUdiDi>
    <tradeName>Slit Lamp Microscope</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12120108</emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL400L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:22.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087545027</udiDi>
    <basicUdiDi>69450875SlitLamp2P</basicUdiDi>
    <tradeName>Slit Lamp Microscope</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12120108</emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL450L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:22.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087565018</udiDi>
    <basicUdiDi>69450875SlitLamp2P</basicUdiDi>
    <tradeName>Slit Lamp Microscope</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12120108</emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL650</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:22.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087580004</udiDi>
    <basicUdiDi>69450875TonometersV5</basicUdiDi>
    <tradeName>Applanation Tonometer</tradeName>
    <deviceName></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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12120122</emdnCode>
    <emdnDescription>TONOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TAT-80R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:22.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087590003</udiDi>
    <basicUdiDi>69450875SlitLamp2P</basicUdiDi>
    <tradeName>Slit Lamp Microscope</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12120108</emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSL-900Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:22.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087590010</udiDi>
    <basicUdiDi>69450875SlitLamp2P</basicUdiDi>
    <tradeName>Slit Lamp Microscope</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>Z12120108</emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSL-900H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:22.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087590027</udiDi>
    <basicUdiDi>69450875SlitLamps2C</basicUdiDi>
    <tradeName>Slit Lamp Microscope</tradeName>
    <deviceName></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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12120108</emdnCode>
    <emdnDescription>SLIT LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6945087590027</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:22.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760377340013</udiDi>
    <basicUdiDi>B-03760377340013</basicUdiDi>
    <tradeName>OdySight</tradeName>
    <deviceName>OdySight</deviceName>
    <manufacturerName>TILAK HEALTHCARE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000011759</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>OdySight</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:20:10.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>03615020000397</udiDi>
    <basicUdiDi>B-03615020000397</basicUdiDi>
    <tradeName>Digital C.R.P</tradeName>
    <deviceName>Digital C.R.P</deviceName>
    <manufacturerName>ESSILOR INTERNATIONAL</manufacturerName>
    <manufacturerSrn>FR-MF-000007175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120125</emdnCode>
    <emdnDescription>PUPILLOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X81705</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:01:16.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002116</udiDi>
    <basicUdiDi>B-00897826002116</basicUdiDi>
    <tradeName>AccuTip Covers, 600/bx, bulk</tradeName>
    <deviceName>AccuTip Covers, 600/bx, bulk</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AX11286</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:30.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002109</udiDi>
    <basicUdiDi>B-00897826002109</basicUdiDi>
    <tradeName>AccuTip Covers, 100 sleeved bulk bag</tradeName>
    <deviceName>AccuTip Covers, 100 sleeved bulk bag</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AX11526</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:26.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002093</udiDi>
    <basicUdiDi>B-00897826002093</basicUdiDi>
    <tradeName>AccuTip Covers, 300/bx, individually wrapped</tradeName>
    <deviceName>AccuTip Covers, 300/bx, individually wrapped</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AX11932</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:25.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002086</udiDi>
    <basicUdiDi>B-00897826002086</basicUdiDi>
    <tradeName>AccuTip Covers, 100/bx, individually wrapped</tradeName>
    <deviceName>AccuTip Covers, 100/bx, individually wrapped</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AX9950</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:24.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002000</udiDi>
    <basicUdiDi>B-00897826002000</basicUdiDi>
    <tradeName>AccuPen</tradeName>
    <deviceName>AccuPen</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120122</emdnCode>
    <emdnDescription>TONOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-3000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:17.462Z</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>00857377006018</udiDi>
    <basicUdiDi>B-00857377006018</basicUdiDi>
    <tradeName>Pachette 4</tradeName>
    <deviceName>Pachette 4</deviceName>
    <manufacturerName>DGH Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008833</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120116</emdnCode>
    <emdnDescription>PACHYMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DGH 555B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:21.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857377006001</udiDi>
    <basicUdiDi>B-00857377006001</basicUdiDi>
    <tradeName>Pachmate 2</tradeName>
    <deviceName>Pachmate 2</deviceName>
    <manufacturerName>DGH Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008833</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120116</emdnCode>
    <emdnDescription>PACHYMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DGH 55B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:20.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855730007412</udiDi>
    <basicUdiDi>B-00855730007412</basicUdiDi>
    <tradeName>MaculoScope</tradeName>
    <deviceName>MaculoScope</deviceName>
    <manufacturerName>Diagnosys LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002934</manufacturerSrn>
    <authorisedRepresentativeName>Diagnosys Vision Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002659</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D130</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:29:11.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>00855730007405</udiDi>
    <basicUdiDi>B-00855730007405</basicUdiDi>
    <tradeName>PSG Pattern Stimulator:</tradeName>
    <deviceName>PSG Pattern Stimulator</deviceName>
    <manufacturerName>Diagnosys LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002934</manufacturerSrn>
    <authorisedRepresentativeName>Diagnosys Vision Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002659</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D217</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:29:07.742Z</lastUpdated>
  </row>
</eudamedExport>