<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04961333232895</udiDi>
    <basicUdiDi>B-04961333232895</basicUdiDi>
    <tradeName>PENTAX Medical Video Processor EPK-i5500c</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001P221S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333233700</udiDi>
    <basicUdiDi>B-04961333233700</basicUdiDi>
    <tradeName>PENTAX Medical Video PROCESSOR EPK-3000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001P208S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333237753</udiDi>
    <basicUdiDi>4961333010102XE</basicUdiDi>
    <tradeName>PENTAX Medical Video Colonoscope EC34-i10cF</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO COLONOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S216S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333237821</udiDi>
    <basicUdiDi>4961333010102XE</basicUdiDi>
    <tradeName>PENTAX Medical Video Colonoscope EC34-i10cM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO COLONOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S216S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333237890</udiDi>
    <basicUdiDi>4961333010102XE</basicUdiDi>
    <tradeName>PENTAX Medical Video Colonoscope EC38-i10cL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO COLONOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S216S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333237968</udiDi>
    <basicUdiDi>4961333010102XE</basicUdiDi>
    <tradeName>PENTAX Medical Video Colonoscope EC38-i10cF</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO COLONOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S216S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333238033</udiDi>
    <basicUdiDi>4961333010102XE</basicUdiDi>
    <tradeName>PENTAX Medical Video Colonoscope EC38-i10cM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO COLONOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S216S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333239382</udiDi>
    <basicUdiDi>4961333010509YG</basicUdiDi>
    <tradeName>PENTAX Medical Cleaning Adapter OE-G1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001A047S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333239399</udiDi>
    <basicUdiDi>4961333010509YG</basicUdiDi>
    <tradeName>PENTAX Medical Cleaning Adapter OE-B10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001A046S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333239603</udiDi>
    <basicUdiDi>4961333010201XH</basicUdiDi>
    <tradeName>PENTAX Medical Ultrasound Upper G.I. Video Scope EG36-J10UR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ECHO–GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S208S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333239702</udiDi>
    <basicUdiDi>4961333010201XH</basicUdiDi>
    <tradeName>PENTAX Medical Ultrasound Upper G.I. Video Scope EG34-J10U</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ECHO–GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S207S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333239757</udiDi>
    <basicUdiDi>B-04961333239757</basicUdiDi>
    <tradeName>PENTAX Medical Single Use Balloon OE-A60</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001Z850S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333245727</udiDi>
    <basicUdiDi>4961333010102XE</basicUdiDi>
    <tradeName>PENTAX Medical Video Colonoscope EC38-i10cF2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO COLONOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S216S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333245833</udiDi>
    <basicUdiDi>4961333010101XC</basicUdiDi>
    <tradeName>PENTAX Medical Video Bronchoscope EB11-J10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO BRONCHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S252S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333245932</udiDi>
    <basicUdiDi>4961333010102XE</basicUdiDi>
    <tradeName>PENTAX Medical Video Colonoscope EC34-i10NL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO COLONOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S267S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333245963</udiDi>
    <basicUdiDi>4961333010102XE</basicUdiDi>
    <tradeName>PENTAX Medical Video Colonoscope EC34-i10NF</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO COLONOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S267S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333246038</udiDi>
    <basicUdiDi>4961333010104XJ</basicUdiDi>
    <tradeName>PENTAX Medical Video Upper GI Scope EG17-J10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S257S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333247424</udiDi>
    <basicUdiDi>496133303660026</basicUdiDi>
    <tradeName>Phonatory Aerodynamic System (PAS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PENTAX of America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008135</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333249169</udiDi>
    <basicUdiDi>B-04961333249169</basicUdiDi>
    <tradeName>PENTAX Medical Video PROCESSOR EPK-3000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001P208S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333249268</udiDi>
    <basicUdiDi>B-04961333249268</basicUdiDi>
    <tradeName>PENTAX Medical Video PROCESSOR EPK-3000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001P208S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.280Z</lastUpdated>
  </row>
</eudamedExport>