<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>14961333232991</udiDi>
    <basicUdiDi>4961333010512Y5</basicUdiDi>
    <tradeName>PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63</tradeName>
    <deviceName>Single Use, Sterile Distal End Cap with Elevator</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>MDR 2017/745</legislation>
    <emdnCode>G0380</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001A042S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:00:44.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>14961333221438</udiDi>
    <basicUdiDi>4961333010513Y7</basicUdiDi>
    <tradeName>PENTAX Medical Single Use Suction Control Valve OF-B205</tradeName>
    <deviceName>PENTAX Medical Single Use Suction Control Valve OF-B205</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>MDR 2017/745</legislation>
    <emdnCode>G0380</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001A027S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:00:43.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333254620</udiDi>
    <basicUdiDi>4961333010520Y4</basicUdiDi>
    <tradeName>PENTAX Medical R/L Assistant Knob OE-B17</tradeName>
    <deviceName>PENTAX Medical R/L Assistant Knob</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001A097</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:44.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333252121</udiDi>
    <basicUdiDi>4961333010514Y9</basicUdiDi>
    <tradeName>PENTAX Medical Gas/Water Feeding Valve OE-B14</tradeName>
    <deviceName>Gas/Water feeding valve</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001A085S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:44.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333252039</udiDi>
    <basicUdiDi>4961333010103XG</basicUdiDi>
    <tradeName>PENTAX Medical Video Duodenoscope ED34-i10cT</tradeName>
    <deviceName>PENTAX Medical Video Duodenoscope</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO GASTRODUODENOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S339S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:43.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333247950</udiDi>
    <basicUdiDi>4961333010301XN</basicUdiDi>
    <tradeName>PENTAX Medical Video Processor EPK-i8020c</tradeName>
    <deviceName>PENTAX Medical Video Processor</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001P225S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:41.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333246120</udiDi>
    <basicUdiDi>4961333010112XH</basicUdiDi>
    <tradeName>PENTAX Medical Video Espohagoscope EE17-J10</tradeName>
    <deviceName>PENTAX Medical Video Esophagoscope</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO OESOPHAGOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S257S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:40.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333239504</udiDi>
    <basicUdiDi>4961333010201XH</basicUdiDi>
    <tradeName>PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT</tradeName>
    <deviceName>PENTAX Medical Ultrasound Upper G.I. Video Scope</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ECHO–GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S207S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:38.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333237685</udiDi>
    <basicUdiDi>4961333010102XE</basicUdiDi>
    <tradeName>PENTAX Medical Video Colonoscope EC34-i10cL</tradeName>
    <deviceName>PENTAX Medical Video Colonoscope</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO COLONOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S216S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:37.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333237616</udiDi>
    <basicUdiDi>4961333010104XJ</basicUdiDi>
    <tradeName>PENTAX Medical Video Upper GI Scope EG29-i10c</tradeName>
    <deviceName>PENTAX Medical Video Upper GI Scope</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S210S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:36.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333225446</udiDi>
    <basicUdiDi>4961333010101XC</basicUdiDi>
    <tradeName>PENTAX Medical Video Bronchoscope EB15-J10</tradeName>
    <deviceName>PENTAX Medical Video Bronchoscope EB11-J10</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO BRONCHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S031S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:13.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333063734</udiDi>
    <basicUdiDi>4961333010509YG</basicUdiDi>
    <tradeName>SUCTION CHANNEL CLEANING &amp; DISINFECTION ADAPTER OF-B103</tradeName>
    <deviceName>Channel Cleaning Adapter</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>MDR 2017/745</legislation>
    <emdnCode>V0799</emdnCode>
    <emdnDescription>PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001Z970S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:12.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333063710</udiDi>
    <basicUdiDi>4961333010507YC</basicUdiDi>
    <tradeName>Cleaning Brush CS6015ST</tradeName>
    <deviceName>PENTAX Medical Cleaning Brush</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001Z638S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:11.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>14961333246233</udiDi>
    <basicUdiDi>4961333010512Y5</basicUdiDi>
    <tradeName>Single Use, Sterile Distal End Cap with Elevator OE-A65</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>MDR 2017/745</legislation>
    <emdnCode>G0380</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001A064S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:36:25.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>14961333226167</udiDi>
    <basicUdiDi>B-14961333226167</basicUdiDi>
    <tradeName>PENTAX Medical PROfILE Single Use Endoscope Inlet seal OF-B215</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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001T012S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:24:08.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>14961333228796</udiDi>
    <basicUdiDi>4961333010507YC</basicUdiDi>
    <tradeName>PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS5522A</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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001T007S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:24:08.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333063932</udiDi>
    <basicUdiDi>4961333010507YC</basicUdiDi>
    <tradeName>Cleaning Brush CS6021SN</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>6217001Z638S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333070459</udiDi>
    <basicUdiDi>4961333010509YG</basicUdiDi>
    <tradeName>Channel Cleaning Adapter OF-B115</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>6217001Z726S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333070633</udiDi>
    <basicUdiDi>4961333010507YC</basicUdiDi>
    <tradeName>Cleaning Brush CS3010S</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>6217001Z638S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333070640</udiDi>
    <basicUdiDi>4961333010507YC</basicUdiDi>
    <tradeName>Cleaning Brush CS6002SN</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>6217001Z638S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.892Z</lastUpdated>
  </row>
</eudamedExport>