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<eudamedExport entity="devices">
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    <udiDi>+B091153050X</udiDi>
    <basicUdiDi>++B091DiplopiaTest5C</basicUdiDi>
    <tradeName>LED Three Character Test</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STRABISMUS DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15305</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:25.001Z</lastUpdated>
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    <udiDi>+B091153140X</udiDi>
    <basicUdiDi>++B091FixationSticksGY</basicUdiDi>
    <tradeName>Pediatric Fixation Sticks (3pk)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL AUDITORY AND/OR VISUAL STIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15314</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:24.988Z</lastUpdated>
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    <udiDi>+B091153150Y</udiDi>
    <basicUdiDi>++B091FixationSticksGY</basicUdiDi>
    <tradeName>Face Fixation Sticks (3pk)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL AUDITORY AND/OR VISUAL STIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15315</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:24.963Z</lastUpdated>
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    <udiDi>+B091153160Z</udiDi>
    <basicUdiDi>++B091TestingGlassesKT</basicUdiDi>
    <tradeName>Red &amp; Green Wrap-Around Glasses, Adult</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15316</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:24.936Z</lastUpdated>
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    <udiDi>+B091153170-</udiDi>
    <basicUdiDi>++B091TestingGlassesKT</basicUdiDi>
    <tradeName>Red &amp; Green Wrap-Around Glasses, Child</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15317</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:24.909Z</lastUpdated>
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    <udiDi>+B091153180.</udiDi>
    <basicUdiDi>++B091TestingGlassesKT</basicUdiDi>
    <tradeName>Reversed Red &amp; Green Wrap-Around Glasses, Adult</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15318</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:24.885Z</lastUpdated>
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    <udiDi>+B091153190_</udiDi>
    <basicUdiDi>++B091TestingGlassesKT</basicUdiDi>
    <tradeName>Reversed Red &amp; Green Wrap-Around Glasses, Child</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15319</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:24.865Z</lastUpdated>
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    <udiDi>+B091153200U</udiDi>
    <basicUdiDi>++B091TestingGlassesKT</basicUdiDi>
    <tradeName>Red &amp; Green Black Frame Glasses (6pk)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15320</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:24.840Z</lastUpdated>
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  <row>
    <udiDi>+B091153210V</udiDi>
    <basicUdiDi>++B091TestingGlassesKT</basicUdiDi>
    <tradeName>Red &amp; Green Pediatric Glasses (6pk)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15321</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:24.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B091153250Z</udiDi>
    <basicUdiDi>++B091FixationSticksGY</basicUdiDi>
    <tradeName>Flashing Fixation Sticks (2pk)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL AUDITORY AND/OR VISUAL STIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15325</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:24.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B091190010U</udiDi>
    <basicUdiDi>++B091TestingGlassesKT</basicUdiDi>
    <tradeName>Red &amp; Green Adult Black Frame #1</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:24.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B091190020V</udiDi>
    <basicUdiDi>++B091TestingGlassesKT</basicUdiDi>
    <tradeName>Reverse Red &amp; Green Adult Black Frame #2</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:24.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B091190030W</udiDi>
    <basicUdiDi>++B091TestingGlassesKT</basicUdiDi>
    <tradeName>Red &amp; Green Pediatric Frame #3</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:24.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B091190040X</udiDi>
    <basicUdiDi>++B091TestingGlassesKT</basicUdiDi>
    <tradeName>Reverse Red &amp; Green Pediatric Frame #4</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:24.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810038637884</udiDi>
    <basicUdiDi>B-00810038637884</basicUdiDi>
    <tradeName>Easy@Home Digital Pregnancy Rapid Test</tradeName>
    <deviceName>Digital Pregnancy Rapid Test</deviceName>
    <manufacturerName>Guangzhou Decheng Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013536</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0811S7X002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:59.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>00608337001686</udiDi>
    <basicUdiDi>B-00608337001686</basicUdiDi>
    <tradeName>OraQuick HIV Self-Test</tradeName>
    <deviceName>OraQuick HIV Self-Test, Single Unit, CE, Greece/Cyprus</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-0629U</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:49.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>00608337001662</udiDi>
    <basicUdiDi>B-00608337001662</basicUdiDi>
    <tradeName>OraQuick TEST HIV PENTRU AUTOTESTARE</tradeName>
    <deviceName>OraQuick HIV Self-Test, Single Unit, CE, Bulgaria/Romania</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-0627U</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:48.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>00608337001532</udiDi>
    <basicUdiDi>B-00608337001532</basicUdiDi>
    <tradeName>AUTOTEST PER L’HIV OraQuick</tradeName>
    <deviceName>OraQuick HIV Self-Test, Single Unit, CE, France/Italy</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-0603U</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:47.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>00608337001679</udiDi>
    <basicUdiDi>B-00608337001679</basicUdiDi>
    <tradeName>Test OraQuick NA OBECNOŚĆ WIRUSA HIV DO SAMODZIELNEGO WYKONANIA</tradeName>
    <deviceName>OraQuick HIV Self-Test, Single Unit, CE, Poland</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-0628U</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:45.971Z</lastUpdated>
  </row>
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    <udiDi>00608337001525</udiDi>
    <basicUdiDi>B-00608337001525</basicUdiDi>
    <tradeName>OraQuick HIV Self-Test</tradeName>
    <deviceName>OraQuick HIV Self-Test, Single Unit, CE, Germany</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-0602U</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:43.565Z</lastUpdated>
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</eudamedExport>