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<eudamedExport entity="devices">
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    <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>
  <row>
    <udiDi>04582428445053</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 T30G45R</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>2037125</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:17.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428445046</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 T30G40R</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>2037124</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:16.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428445039</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 T30G35R</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>2037123</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:15.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428445008</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L25G50R</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>2037120</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:13.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428444995</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L25G45R</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>2037119</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:12.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428444988</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L25G40R</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>2037118</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:10.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428444971</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L25G35R</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>2037117</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:09.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428444957</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 T25G50R</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>2037115</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:07.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428444940</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 T25G45R</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>2037114</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:07.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428444933</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 T25G40R</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>2037113</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:05.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428444926</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 T25G35R</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>2037112</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:04.400Z</lastUpdated>
  </row>
</eudamedExport>