<?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>08719214223632</udiDi>
    <basicUdiDi>871921422994GQ</basicUdiDi>
    <tradeName>08719214223632</tradeName>
    <deviceName>Phacoemulsification/ Vitrectomy System</deviceName>
    <manufacturerName>VitreQ B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000424</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>EQ00.R01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:53:40.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719214223557</udiDi>
    <basicUdiDi>871921422997GW</basicUdiDi>
    <tradeName>08719214223557</tradeName>
    <deviceName>Sterile Viscous Fluid Injection / Extraction Tool</deviceName>
    <manufacturerName>VitreQ B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000424</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212020785</emdnCode>
    <emdnDescription>PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VF00.D01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:53:38.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719214223489</udiDi>
    <basicUdiDi>871921422995GS</basicUdiDi>
    <tradeName>08719214223489</tradeName>
    <deviceName>Sterile Ophthalmic Surgical Procedure Pack</deviceName>
    <manufacturerName>VitreQ B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000424</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212020785</emdnCode>
    <emdnDescription>PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA00.D02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:53:36.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719214223397</udiDi>
    <basicUdiDi>871921422998GY</basicUdiDi>
    <tradeName>08719214223397</tradeName>
    <deviceName>Sterile Ophthalmic Cannulation Sets</deviceName>
    <manufacturerName>VitreQ B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000424</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212020785</emdnCode>
    <emdnDescription>PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES27.D02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:53:33.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719214223250</udiDi>
    <basicUdiDi>871921422999H2</basicUdiDi>
    <tradeName>08719214223250</tradeName>
    <deviceName>Sterile Vitrectomy Probes</deviceName>
    <manufacturerName>VitreQ B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000424</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212020703</emdnCode>
    <emdnDescription>VITRECTOMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT23.D01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:53:32.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719214222093</udiDi>
    <basicUdiDi>871921422990GG</basicUdiDi>
    <tradeName>08719214222093</tradeName>
    <deviceName>Sterile Light Fibers</deviceName>
    <manufacturerName>VitreQ B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000424</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212020785</emdnCode>
    <emdnDescription>PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LF23.D01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:53:29.859Z</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>05050474617193</udiDi>
    <basicUdiDi>5050474a000079E</basicUdiDi>
    <tradeName>PATIENT CHAIR</tradeName>
    <deviceName>CATALYS PATIENT CHAIR</deviceName>
    <manufacturerName>AMO Manufacturing USA, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023322</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</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>0160-6030</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:58:38.912Z</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>04987669101773</udiDi>
    <basicUdiDi>4987669221G8</basicUdiDi>
    <tradeName>OPHTHALMIC SURGICAL SYSTEM CV-30000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212020785</emdnCode>
    <emdnDescription>PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fortas_B01E007</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:43:28.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669101629</udiDi>
    <basicUdiDi>4987669222GA</basicUdiDi>
    <tradeName>OPHTHALMIC SURGICAL SYSTEM CV-9000R</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1212020785</emdnCode>
    <emdnDescription>PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cubeα_B01E001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:43:05.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669100080</udiDi>
    <basicUdiDi>4987669220G6</basicUdiDi>
    <tradeName>Multicolor Laser Photocoagulator MC-500</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120202</emdnCode>
    <emdnDescription>LASER PHOTOCOAGULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B02E002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:28.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260284390013</udiDi>
    <basicUdiDi>426028439NAVILASKZ</basicUdiDi>
    <tradeName>Navilas Laser System 577s</tradeName>
    <deviceName>Navilas</deviceName>
    <manufacturerName>OD-OS GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120202</emdnCode>
    <emdnDescription>LASER PHOTOCOAGULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>156000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:50:04.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049539106858</udiDi>
    <basicUdiDi>4049539_1_0685_TG</basicUdiDi>
    <tradeName>ULITE PLUS PHACO HANDPIECE</tradeName>
    <deviceName>ULITE PLUS PHACO HANDPIECE</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>Z1212020785</emdnCode>
    <emdnDescription>PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303061-9300-000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:01:28.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049471095104</udiDi>
    <basicUdiDi>4049471_VM0002_33</basicUdiDi>
    <tradeName>VISUMAX 600</tradeName>
    <deviceName>VISUMAX</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>Z1212020501</emdnCode>
    <emdnDescription>MICROKERATOME LASERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:01:22.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049471110258</udiDi>
    <basicUdiDi>B-04049471110258</basicUdiDi>
    <tradeName>Endoprobe</tradeName>
    <deviceName>Endoprobe</deviceName>
    <manufacturerName>Carl Zeiss Meditec AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007732</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120285</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1758-736</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T21:14:19.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049471110241</udiDi>
    <basicUdiDi>B-04049471110241</basicUdiDi>
    <tradeName>Endoprobe</tradeName>
    <deviceName>Endoprobe</deviceName>
    <manufacturerName>Carl Zeiss Meditec AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007732</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120285</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1505-917</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T21:14:15.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049471110234</udiDi>
    <basicUdiDi>B-04049471110234</basicUdiDi>
    <tradeName>Endoprobe</tradeName>
    <deviceName>Endoprobe</deviceName>
    <manufacturerName>Carl Zeiss Meditec AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007732</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120285</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1505-916</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T21:14:15.834Z</lastUpdated>
  </row>
</eudamedExport>