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    <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>
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    <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>
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    <udiDi>00855730007399</udiDi>
    <basicUdiDi>B-00855730007399</basicUdiDi>
    <tradeName>ColorBurst</tradeName>
    <deviceName>ColorBurst</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>Piyasada</deviceStatus>
    <reference>D213</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:29:06.934Z</lastUpdated>
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    <udiDi>00855730007375</udiDi>
    <basicUdiDi>B-00855730007375</basicUdiDi>
    <tradeName>ColorFlash</tradeName>
    <deviceName>ColorFlash</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>Piyasada</deviceStatus>
    <reference>D382</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:29:06.135Z</lastUpdated>
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    <udiDi>00855730007368</udiDi>
    <basicUdiDi>B-00855730007368</basicUdiDi>
    <tradeName>EER</tradeName>
    <deviceName>EER</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>Piyasada</deviceStatus>
    <reference>D366</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:29:05.615Z</lastUpdated>
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    <udiDi>00855730007351</udiDi>
    <basicUdiDi>B-00855730007351</basicUdiDi>
    <tradeName>Envoy</tradeName>
    <deviceName>Envoy</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>Piyasada</deviceStatus>
    <reference>D352</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:29:01.345Z</lastUpdated>
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    <udiDi>00855730007344</udiDi>
    <basicUdiDi>B-00855730007344</basicUdiDi>
    <tradeName>ColorDome</tradeName>
    <deviceName>ColorDome</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>Piyasada</deviceStatus>
    <reference>D125</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:29:00.551Z</lastUpdated>
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    <udiDi>00855730007313</udiDi>
    <basicUdiDi>B-00855730007313</basicUdiDi>
    <tradeName>Attache</tradeName>
    <deviceName>Attache</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>Piyasada</deviceStatus>
    <reference>D341</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:59.737Z</lastUpdated>
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    <udiDi>00855730007306</udiDi>
    <basicUdiDi>B-00855730007306</basicUdiDi>
    <tradeName>E3</tradeName>
    <deviceName>E3</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>Piyasada</deviceStatus>
    <reference>D315</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:58.947Z</lastUpdated>
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    <udiDi>00855730007290</udiDi>
    <basicUdiDi>B-00855730007290</basicUdiDi>
    <tradeName>Profile</tradeName>
    <deviceName>Profile</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>Piyasada</deviceStatus>
    <reference>D310</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:28:54.125Z</lastUpdated>
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  <row>
    <udiDi>00850594007011</udiDi>
    <basicUdiDi>B-00850594007011</basicUdiDi>
    <tradeName>DTL Plus Electrodes</tradeName>
    <deviceName>DTL Plus Electrodes</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>Q029002</emdnCode>
    <emdnDescription>OPHTHALMOLOGICAL DIAGNOSTIC ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D141</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:10:10.374Z</lastUpdated>
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    <udiDi>00850594007004</udiDi>
    <basicUdiDi>B-00850594007004</basicUdiDi>
    <tradeName>Standalone</tradeName>
    <deviceName>Standalone</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>Piyasada</deviceStatus>
    <reference>D175</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:10:09.564Z</lastUpdated>
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