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    <basicUdiDi>B-ESMF000024270CAMPIME14X</basicUdiDi>
    <tradeName>DALTE</tradeName>
    <deviceName>PANTALLA TANGENTE PARA DIAGNÓSTICO DEL CAMPO VISUAL</deviceName>
    <manufacturerName>MNM INGENIERIA SCA</manufacturerName>
    <manufacturerSrn>ES-MF-000024270</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAMPIME1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:02:27.363Z</lastUpdated>
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    <udiDi>05903684803545</udiDi>
    <basicUdiDi>590368480M007BM</basicUdiDi>
    <tradeName>OKO z dwoma optotypami: cyfry, obrazki</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDEN-INMED SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000001670</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:08:27.304Z</lastUpdated>
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    <udiDi>00855730007412</udiDi>
    <basicUdiDi>B-00855730007412</basicUdiDi>
    <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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  <row>
    <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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  <row>
    <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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  <row>
    <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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  <row>
    <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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  <row>
    <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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  <row>
    <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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  <row>
    <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>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>
  </row>
  <row>
    <udiDi>+B091111230R</udiDi>
    <basicUdiDi>++B091LensHoldersC6</basicUdiDi>
    <tradeName>Color Coded Flipper Set</tradeName>
    <deviceName></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>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11123</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:27.223Z</lastUpdated>
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  <row>
    <udiDi>+B091151400U</udiDi>
    <basicUdiDi>++B091LensHoldersC6</basicUdiDi>
    <tradeName>Lens Holder Handle</tradeName>
    <deviceName></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>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:25.275Z</lastUpdated>
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    <udiDi>+B091151410V</udiDi>
    <basicUdiDi>++B091LensHoldersC6</basicUdiDi>
    <tradeName>Lens Holder Nose Bridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15141</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:25.252Z</lastUpdated>
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    <udiDi>+B091151420W</udiDi>
    <basicUdiDi>++B091LensHoldersC6</basicUdiDi>
    <tradeName>Lens Holder without Scale</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15142</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:25.227Z</lastUpdated>
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    <udiDi>+B091151430X</udiDi>
    <basicUdiDi>++B091LensHoldersC6</basicUdiDi>
    <tradeName>Lens Holder with Scale</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:25.212Z</lastUpdated>
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    <udiDi>+B091151440Y</udiDi>
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    <tradeName>Lens Holder Kit 4 Well</tradeName>
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    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:25.196Z</lastUpdated>
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    <tradeName>Lens Holder Kit 8 Well</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <emdnCode>Z1212012001</emdnCode>
    <emdnDescription>VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15145</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:25.183Z</lastUpdated>
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