<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-USMF000014446000025S8</udiDi>
    <basicUdiDi>B-USMF000014446000025S8</basicUdiDi>
    <tradeName>D-USMF000014446000025S8</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>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-100120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:43.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000024S6</udiDi>
    <basicUdiDi>B-USMF000014446000024S6</basicUdiDi>
    <tradeName>D-USMF000014446000024S6</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>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-100106</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:41.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000023S4</udiDi>
    <basicUdiDi>B-USMF000014446000023S4</basicUdiDi>
    <tradeName>D-USMF000014446000023S4</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>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-100105</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:41.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000022S2</udiDi>
    <basicUdiDi>B-USMF000014446000022S2</basicUdiDi>
    <tradeName>D-USMF000014446000022S2</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>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-100103</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:39.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000021RY</udiDi>
    <basicUdiDi>B-USMF000014446000021RY</basicUdiDi>
    <tradeName>D-USMF000014446000021RY</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>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-100102</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:37.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000020RW</udiDi>
    <basicUdiDi>B-USMF000014446000020RW</basicUdiDi>
    <tradeName>D-USMF000014446000020RW</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>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-100101</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:35.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053677040123</udiDi>
    <basicUdiDi>805367704EIDON-UWFDW</basicUdiDi>
    <tradeName>08053677040123</tradeName>
    <deviceName>EIDON UWF Module</deviceName>
    <manufacturerName>CENTERVUE S.P.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000017082</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AXWFLME001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:49:33.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430046260979</udiDi>
    <basicUdiDi>643004626cradle20BL</basicUdiDi>
    <tradeName>Optomed Lumo Charging Station</tradeName>
    <deviceName>Optomed Lumo Charging Station</deviceName>
    <manufacturerName>Optomed Oyj</manufacturerName>
    <manufacturerSrn>FI-MF-000009407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41002612</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:54:45.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272717069</udiDi>
    <basicUdiDi>50552727LIOACCESSORIESUS</basicUdiDi>
    <tradeName>LIO ACCESSORY KIT</tradeName>
    <deviceName>LIO ACCESSORY KIT</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1205-P-7015</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:40:57.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272715942</udiDi>
    <basicUdiDi>50552727TABLESHE</basicUdiDi>
    <tradeName>LED TABLE TOP ACCESSORY KIT</tradeName>
    <deviceName>TABLES</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3020-P-7021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:40:57.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272715928</udiDi>
    <basicUdiDi>50552727STANDSPJ</basicUdiDi>
    <tradeName>REFRACTION STAND PSU &amp; SKT KIT</tradeName>
    <deviceName>STANDS</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3020-P-7017</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:40:56.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272715782</udiDi>
    <basicUdiDi>50552727SLITLAMPACCESSHF</basicUdiDi>
    <tradeName>12V PSU &amp; DRAWER KIT</tradeName>
    <deviceName>SLIT LAMP ACCESSORIES</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3020-P-5121</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:40:55.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272715027</udiDi>
    <basicUdiDi>50552727TUBESNX</basicUdiDi>
    <tradeName>0.4MM TUBE X20M</tradeName>
    <deviceName>TUBES</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2417-P-7034</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:40:54.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272711616</udiDi>
    <basicUdiDi>50552727MOUNTINGPLATES7Y</basicUdiDi>
    <tradeName>KAT T TYPE GLIDE PLATE</tradeName>
    <deviceName>MOUNTING PLATES</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2414-P-5032</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:40:53.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272711463</udiDi>
    <basicUdiDi>50552727DUSTCOVERRM</basicUdiDi>
    <tradeName>PULSAIR DESKTOP DUST COVER</tradeName>
    <deviceName>DUST COVER</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EP39-70435</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:40:51.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272711173</udiDi>
    <basicUdiDi>50552727CALIBRATIONAF</basicUdiDi>
    <tradeName>PULSAIR CALIBRATION SYSTEM</tradeName>
    <deviceName>CALIBRATION ACCESSORIES</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2414-P-2005</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:40:49.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272708463</udiDi>
    <basicUdiDi>50552727CASESFD</basicUdiDi>
    <tradeName>SPECTRA+ SOFT CASE</tradeName>
    <deviceName>LIO CARRY CASE &amp; CARTON</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3412-P-7002</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:40:49.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272708074</udiDi>
    <basicUdiDi>50552727CHINPAPER9W</basicUdiDi>
    <tradeName>CHIN REST PAPERS</tradeName>
    <deviceName>CHINREST PAPER</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3104-L-8201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:40:48.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272704229</udiDi>
    <basicUdiDi>50552727CAPSKU</basicUdiDi>
    <tradeName>STANDARD LOUPES PROTECTIVE CAPS</tradeName>
    <deviceName>CAPS</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2112-P-8049</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:40:47.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055272705516</udiDi>
    <basicUdiDi>50552727CLOTHSJN</basicUdiDi>
    <tradeName>KEELER LENS CLOTH</tradeName>
    <deviceName>Cloth</deviceName>
    <manufacturerName>Keeler Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000009031</manufacturerSrn>
    <authorisedRepresentativeName>Keeler Europe Distribution, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001559</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120180</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2199-P-7136</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:40:45.860Z</lastUpdated>
  </row>
</eudamedExport>