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    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-210037</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:28.330Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>REF-220120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:26.728Z</lastUpdated>
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    <udiDi>D-USMF000014446000010RT</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-210028</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:24.574Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-210024</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:09.068Z</lastUpdated>
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    <udiDi>D-USMF000014446000008S8</udiDi>
    <basicUdiDi>B-USMF000014446000008S8</basicUdiDi>
    <tradeName>D-USMF000014446000008S8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-210023</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:08.270Z</lastUpdated>
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  <row>
    <udiDi>D-USMF000014446000007S6</udiDi>
    <basicUdiDi>B-USMF000014446000007S6</basicUdiDi>
    <tradeName>D-USMF000014446000007S6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-210019</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:07.485Z</lastUpdated>
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  <row>
    <udiDi>D-USMF000014446000006S4</udiDi>
    <basicUdiDi>B-USMF000014446000006S4</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-210007</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:06.687Z</lastUpdated>
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  <row>
    <udiDi>D-USMF000014446000005S2</udiDi>
    <basicUdiDi>B-USMF000014446000005S2</basicUdiDi>
    <tradeName>D-USMF000014446000005S2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-210006</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:02.664Z</lastUpdated>
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  <row>
    <udiDi>D-USMF000014446000004RY</udiDi>
    <basicUdiDi>B-USMF000014446000004RY</basicUdiDi>
    <tradeName>D-USMF000014446000004RY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-210005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:01.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000003RW</udiDi>
    <basicUdiDi>B-USMF000014446000003RW</basicUdiDi>
    <tradeName>D-USMF000014446000003RW</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-210003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:01.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014446000002RU</udiDi>
    <basicUdiDi>B-USMF000014446000002RU</basicUdiDi>
    <tradeName>D-USMF000014446000002RU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TearScience, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014446</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF-210002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:39:00.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-805669782TL</udiDi>
    <basicUdiDi>B-805669782TL</basicUdiDi>
    <tradeName>REXON-EYE</tradeName>
    <deviceName>REXON-EYE</deviceName>
    <manufacturerName>Resono Ophthalmic</manufacturerName>
    <manufacturerSrn>IT-MF-000019770</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4001007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:48:18.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700542625934</udiDi>
    <basicUdiDi>B-03700542625934</basicUdiDi>
    <tradeName>C.STIM</tradeName>
    <deviceName>C.STIM</deviceName>
    <manufacturerName>QUANTEL MEDICAL</manufacturerName>
    <manufacturerSrn>FR-MF-000009724</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.STIM</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:26:38.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B09111101100O</udiDi>
    <basicUdiDi>++B091PrismsTY</basicUdiDi>
    <tradeName>Single Prism - 10 Diopter</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>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B09111101120Q</udiDi>
    <basicUdiDi>++B091PrismsTY</basicUdiDi>
    <tradeName>Single Prism - 12 Diopter</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>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B09111101140S</udiDi>
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    <tradeName>Single Prism - 14 Diopter</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>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B09111101150T</udiDi>
    <basicUdiDi>++B091PrismsTY</basicUdiDi>
    <tradeName>Single Prism - 15 Diopter</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>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B09111101160U</udiDi>
    <basicUdiDi>++B091PrismsTY</basicUdiDi>
    <tradeName>Single Prism - 16 Diopter</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>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B09111101180W</udiDi>
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    <tradeName>Single Prism - 18 Diopter</tradeName>
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    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnCode>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-18</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B09111101200P</udiDi>
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    <tradeName>Single Prism - 20 Diopter</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>Z12120299</emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.066Z</lastUpdated>
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</eudamedExport>