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<eudamedExport entity="devices">
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    <udiDi>04582428447996</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 T20S(K)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037904</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:44.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428447989</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 T50N(B)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037903</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:43.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428447934</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 T40C(B)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037898</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:41.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428447927</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 T35C(B)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037897</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:40.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428447910</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 T30C(B)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037896</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:38.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428447897</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 T30S(B)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037894</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:37.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428447880</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 T25S(B)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037893</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:35.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428447873</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 T20S(B)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037892</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:35.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428446029</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L40C(R)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037890</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:33.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428446012</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L35C(R)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037889</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:32.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428446005</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L30C(R)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037888</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:30.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428445718</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L50N(R)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037870</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:29.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428445671</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L30S(R)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037866</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:27.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428445664</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L25S(R)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037865</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:26.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428445657</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L20S(R)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037864</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:25.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428445138</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L30G50R</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037133</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:24.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428445121</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L30G45R</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037132</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:22.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428445114</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L30G40R</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037131</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:21.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428445107</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L30G35R</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037130</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:19.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428445060</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 T30G50R</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037126</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:18.793Z</lastUpdated>
  </row>
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