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<eudamedExport entity="devices">
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    <udiDi>04582428430585</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L30G40S</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>2037101</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:42.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428430578</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L30G40K</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>2037098</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:41.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428430561</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L30G40B</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>2037100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:40.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428430554</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L30G35S</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>2037097</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:38.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428430547</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L30G35K</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>2037095</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:37.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428430530</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L30G35B</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>2037096</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:35.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428430028</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L50N(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>2037615</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:34.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428430011</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L50N(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>2037614</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:32.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428430004</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L50N(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>2037616</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:31.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428429930</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L30S(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>2037603</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:30.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428429923</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L30S(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>2037602</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:29.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428429916</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L30S(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>2037604</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:27.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428429879</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L25S(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>2037600</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:26.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428429862</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L25S(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>2037599</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:25.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428429855</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L25S(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>2037601</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:23.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428429848</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L20S(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>2037597</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:23.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428429831</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L20S(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>2037596</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:21.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428430608</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX USYFITVUE GP1 L30G45K</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></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-29T12:03:07.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428441642</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L30C(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></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T21:19:16.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582428448030</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 T30C(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></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-28T21:19:16.003Z</lastUpdated>
  </row>
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