<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04961333221646</udiDi>
    <basicUdiDi>4961333010507YC</basicUdiDi>
    <tradeName>PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS5530A</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>ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001T007S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333222216</udiDi>
    <basicUdiDi>4961333010509YG</basicUdiDi>
    <tradeName>PENTAX Medical Cleaning Adapter OE-B11</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>6217001A032S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333223589</udiDi>
    <basicUdiDi>B-04961333223589</basicUdiDi>
    <tradeName>PENTAXMedical Electro-Surgical Knife DN-D Series</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001Y023S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333223619</udiDi>
    <basicUdiDi>B-04961333223619</basicUdiDi>
    <tradeName>PENTAXMedical Electro-Surgical Knife DN-D Series DN-D2722B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001Y023S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333225255</udiDi>
    <basicUdiDi>B-04961333225255</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>2026-06-22T12:16:50.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333225491</udiDi>
    <basicUdiDi>4961333010101XC</basicUdiDi>
    <tradeName>PENTAX Medical Video Bronchoscope EB19-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>6217001S031S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333225583</udiDi>
    <basicUdiDi>B-04961333225583</basicUdiDi>
    <tradeName>PENTAX Medical Ultrasound Video Bronchoscope EB19-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>VIDEO BRONCHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S039S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333228751</udiDi>
    <basicUdiDi>4961333010507YC</basicUdiDi>
    <tradeName>PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS2010A</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>ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001T007S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333228768</udiDi>
    <basicUdiDi>4961333010507YC</basicUdiDi>
    <tradeName>PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS2022A</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>ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001T007S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333228775</udiDi>
    <basicUdiDi>4961333010507YC</basicUdiDi>
    <tradeName>PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS4010A</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>ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001T007S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333228782</udiDi>
    <basicUdiDi>4961333010507YC</basicUdiDi>
    <tradeName>PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS5503A</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>ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001T007S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333228805</udiDi>
    <basicUdiDi>4961333010507YC</basicUdiDi>
    <tradeName>PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS-C11A</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>ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001T008S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333228812</udiDi>
    <basicUdiDi>4961333010507YC</basicUdiDi>
    <tradeName>PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS-C12A</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>ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001T008S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333228829</udiDi>
    <basicUdiDi>4961333010507YC</basicUdiDi>
    <tradeName>PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS-C13A</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>ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001T008S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333230112</udiDi>
    <basicUdiDi>496133303A6611V6</basicUdiDi>
    <tradeName>Screening Tubes</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>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6612</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333230129</udiDi>
    <basicUdiDi>496133303A6610V4</basicUdiDi>
    <tradeName>Airflow Head‑Mask Couplers</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>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6613</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333230136</udiDi>
    <basicUdiDi>496133303A6611V6</basicUdiDi>
    <tradeName>Pressure Port Tubes</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>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6614</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333230501</udiDi>
    <basicUdiDi>496133303A6611V6</basicUdiDi>
    <tradeName>Flowhead Tubes</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>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7189‑4200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333231058</udiDi>
    <basicUdiDi>496133303A6625VH</basicUdiDi>
    <tradeName>Adult Small Disposable Masks</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>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6635</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333231065</udiDi>
    <basicUdiDi>496133303A6625VH</basicUdiDi>
    <tradeName>Adult Large Disposable Masks</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>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6645</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.956Z</lastUpdated>
  </row>
</eudamedExport>