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    <manufacturerName>HOYA Corporation</manufacturerName>
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    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.461Z</lastUpdated>
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    <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>
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    <reference>6217001Y023S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.439Z</lastUpdated>
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    <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>
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    <legislation>UNKNOWN</legislation>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <basicUdiDi>4961333010102XE</basicUdiDi>
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    <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>
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    <basicUdiDi>4961333010102XE</basicUdiDi>
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    <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>
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    <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>
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    <udiDi>04961333238033</udiDi>
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    <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>
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