<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>D-rtx-1RS</udiDi>
    <basicUdiDi>B-rtx-1RS</basicUdiDi>
    <tradeName>rtx1</tradeName>
    <deviceName>rtx1 adaptive optics retinal camera</deviceName>
    <manufacturerName>IMAGINE EYES</manufacturerName>
    <manufacturerSrn>FR-MF-000004148</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>rtx1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:29:59.724Z</lastUpdated>
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  <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-USMF000023322000008N9</udiDi>
    <basicUdiDi>B-USMF000023322000008N9</basicUdiDi>
    <tradeName>D-USMF000023322000008N9</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120285</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>660065AN</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:47:06.758Z</lastUpdated>
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  <row>
    <udiDi>D-USMF000023322000007N7</udiDi>
    <basicUdiDi>B-USMF000023322000007N7</basicUdiDi>
    <tradeName>D-USMF000023322000007N7</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120285</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>590106AN</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:47:05.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000044SC</udiDi>
    <basicUdiDi>B-USMF000014446000044SC</basicUdiDi>
    <tradeName>D-USMF000014446000044SC</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-400028</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:40:26.386Z</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-USMF000014446000045SE</udiDi>
    <basicUdiDi>B-USMF000014446000045SE</basicUdiDi>
    <tradeName>D-USMF000014446000045SE</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-400037</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:40:24.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000042S8</udiDi>
    <basicUdiDi>B-USMF000014446000042S8</basicUdiDi>
    <tradeName>D-USMF000014446000042S8</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-400024</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:40:09.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000041S6</udiDi>
    <basicUdiDi>B-USMF000014446000041S6</basicUdiDi>
    <tradeName>D-USMF000014446000041S6</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-400023</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:40:07.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000040S4</udiDi>
    <basicUdiDi>B-USMF000014446000040S4</basicUdiDi>
    <tradeName>D-USMF000014446000040S4</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-400022</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:40:06.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000039SK</udiDi>
    <basicUdiDi>B-USMF000014446000039SK</basicUdiDi>
    <tradeName>D-USMF000014446000039SK</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-400021</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:40:05.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000038SH</udiDi>
    <basicUdiDi>B-USMF000014446000038SH</basicUdiDi>
    <tradeName>D-USMF000014446000038SH</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-400020</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:40:02.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000037SF</udiDi>
    <basicUdiDi>B-USMF000014446000037SF</basicUdiDi>
    <tradeName>D-USMF000014446000037SF</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-400007</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:40:01.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000036SD</udiDi>
    <basicUdiDi>B-USMF000014446000036SD</basicUdiDi>
    <tradeName>D-USMF000014446000036SD</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-400006</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:40:00.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000035SB</udiDi>
    <basicUdiDi>B-USMF000014446000035SB</basicUdiDi>
    <tradeName>D-USMF000014446000035SB</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-400005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:58.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000034S9</udiDi>
    <basicUdiDi>B-USMF000014446000034S9</basicUdiDi>
    <tradeName>D-USMF000014446000034S9</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-400003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:56.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000033S7</udiDi>
    <basicUdiDi>B-USMF000014446000033S7</basicUdiDi>
    <tradeName>D-USMF000014446000033S7</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-400002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:54.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000031S3</udiDi>
    <basicUdiDi>B-USMF000014446000031S3</basicUdiDi>
    <tradeName>D-USMF000014446000031S3</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-100137</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:53.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000030RZ</udiDi>
    <basicUdiDi>B-USMF000014446000030RZ</basicUdiDi>
    <tradeName>D-USMF000014446000030RZ</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-100125</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:52.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000029SG</udiDi>
    <basicUdiDi>B-USMF000014446000029SG</basicUdiDi>
    <tradeName>D-USMF000014446000029SG</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-100124</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:49.961Z</lastUpdated>
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</eudamedExport>