<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>+B09111L1404</udiDi>
    <basicUdiDi>B-+B09111L1404</basicUdiDi>
    <tradeName>+B09111L1404</tradeName>
    <deviceName>BV-15 &amp; B-16 Prism Bar Case Set</deviceName>
    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11L14</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:56:44.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810051250220</udiDi>
    <basicUdiDi>859623006a005GA</basicUdiDi>
    <tradeName>LIPIFLOW SYSTEM CABLE KIT</tradeName>
    <deviceName>LIPIFLOW SYSTEM CABLE</deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0820-5000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:16:57.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810051250060</udiDi>
    <basicUdiDi>859623006a004G8</basicUdiDi>
    <tradeName>TEARSCIENCE ACTIVATOR CLEAR (DISPOSABLE)</tradeName>
    <deviceName>LIPIFLOW SYSTEM ACTIVATORS</deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0803-5050</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:16:56.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>05050474604797</udiDi>
    <basicUdiDi>5050474a000089G</basicUdiDi>
    <tradeName>CATALYS PRECISION LASER SYSTEM</tradeName>
    <deviceName>CATALYS SYSTEM</deviceName>
    <manufacturerName>AMO Manufacturing USA, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023322</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CATALYS-I</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:58:34.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049471091380</udiDi>
    <basicUdiDi>B-04049471091380</basicUdiDi>
    <tradeName>VISULAS YAG III combi</tradeName>
    <deviceName>VISULAS YAG III</deviceName>
    <manufacturerName>Carl Zeiss Meditec AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007732</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1272-069</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T21:13:37.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049471091373</udiDi>
    <basicUdiDi>B-04049471091373</basicUdiDi>
    <tradeName>VISULAS YAG III</tradeName>
    <deviceName>VISULAS YAG III</deviceName>
    <manufacturerName>Carl Zeiss Meditec AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007732</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1272-175</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T21:13:36.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049471091496</udiDi>
    <basicUdiDi>4049471_VL0004_2U</basicUdiDi>
    <tradeName>VISULAS combi</tradeName>
    <deviceName>VISULAS</deviceName>
    <manufacturerName>Carl Zeiss Meditec AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007732</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2222-003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:02:52.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049471091489</udiDi>
    <basicUdiDi>4049471_VL0003_2R</basicUdiDi>
    <tradeName>VISULAS yag</tradeName>
    <deviceName>VISULAS</deviceName>
    <manufacturerName>Carl Zeiss Meditec AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007732</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2222-004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:02:51.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049539069214</udiDi>
    <basicUdiDi>4049539_00000001_A9</basicUdiDi>
    <tradeName>CALLISTO eye Panel PC</tradeName>
    <deviceName>CALLISTO eye Panel PC</deviceName>
    <manufacturerName>Carl Zeiss Meditec AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007732</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6921</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:46:39.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049539103512</udiDi>
    <basicUdiDi>4049539_00000001_A9</basicUdiDi>
    <tradeName>CALLISTO eye Panel PC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Carl Zeiss Meditec AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007732</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6909</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:38:48.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B749200001030</udiDi>
    <basicUdiDi>B-+B749200001030</basicUdiDi>
    <tradeName>Valeda Light Delivery System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LumiThera, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029866</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200001-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:48:33.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380659982873</udiDi>
    <basicUdiDi>038065GMN000165HC</basicUdiDi>
    <tradeName>WaveLight</tradeName>
    <deviceName>Ophthalmic Excimer Laser</deviceName>
    <manufacturerName>Alcon Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016248</manufacturerSrn>
    <authorisedRepresentativeName>Alcon Laboratories Belgium</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000014721</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1016</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:23:44.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B091111110O</udiDi>
    <basicUdiDi>++B091PrismBarsE2</basicUdiDi>
    <tradeName>LB-14 Large Vertical Prism Bar</tradeName>
    <deviceName>Prism Bar</deviceName>
    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11111</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:46:42.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B091111070T</udiDi>
    <basicUdiDi>++B091VergenceFacilityLR</basicUdiDi>
    <tradeName>Vergence Facility Prism</tradeName>
    <deviceName>Vergence Facility Prism</deviceName>
    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11107</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:46:41.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B091111010O</udiDi>
    <basicUdiDi>++B091PrismsTY</basicUdiDi>
    <tradeName>Single Prism - 1 Diopter</tradeName>
    <deviceName>Prism</deviceName>
    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:46:37.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000023322000009NB</udiDi>
    <basicUdiDi>B-USMF000023322000009NB</basicUdiDi>
    <tradeName>D-USMF000023322000009NB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AMO Manufacturing USA, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023322</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J20007K</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:47:07.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000046SG</udiDi>
    <basicUdiDi>B-USMF000014446000046SG</basicUdiDi>
    <tradeName>D-USMF000014446000046SG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-300000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:40:25.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000019SD</udiDi>
    <basicUdiDi>B-USMF000014446000019SD</basicUdiDi>
    <tradeName>D-USMF000014446000019SD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-240150</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:34.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000018SB</udiDi>
    <basicUdiDi>B-USMF000014446000018SB</basicUdiDi>
    <tradeName>D-USMF000014446000018SB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>REF-240130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:33.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000014S3</udiDi>
    <basicUdiDi>B-USMF000014446000014S3</basicUdiDi>
    <tradeName>D-USMF000014446000014S3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>REF-221020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:30.732Z</lastUpdated>
  </row>
</eudamedExport>