<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>04582428441710</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L40C(S)</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>2037813</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:02.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428441703</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L40C(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>2037812</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:03:01.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428441697</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L40C(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>2037811</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:02:59.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428441680</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L35C(S)</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>2037810</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:02:58.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428441673</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L35C(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>2037809</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:02:57.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428441666</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L35C(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>2037808</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:02:56.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428441659</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L30C(S)</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>2037807</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:02:54.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428441635</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L30C(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>2037805</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:02:45.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428431186</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 T25G50S</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>2037052</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:02:44.765Z</lastUpdated>
  </row>
</eudamedExport>