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    <tradeName>Switch Box Assembly A‑B</tradeName>
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    <manufacturerName>PENTAX of America Inc.</manufacturerName>
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    <tradeName>Phonatory Aerodynamic System (SOFTWARE)</tradeName>
    <deviceName>Phonatory Aerodynamic System (PAS)</deviceName>
    <manufacturerName>PENTAX of America Inc.</manufacturerName>
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    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VOICE DISPLAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6600WU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <udiDi>04961333231041</udiDi>
    <basicUdiDi>496133303A6625VH</basicUdiDi>
    <tradeName>Adult Small Disposable Masks</tradeName>
    <deviceName>Adult Small Disposable Masks</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>MDR 2017/745</legislation>
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    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6625</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:19.205Z</lastUpdated>
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    <udiDi>04961333231034</udiDi>
    <basicUdiDi>496133303A6615VE</basicUdiDi>
    <tradeName>Pediatric Disposable Masks</tradeName>
    <deviceName>Pediatric Disposable Masks</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>MDR 2017/745</legislation>
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    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <udiDi>04961333230105</udiDi>
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    <tradeName>Cardboard Tubes (Disposable)</tradeName>
    <deviceName>Cardboard Tubes (Disposable)</deviceName>
    <manufacturerName>PENTAX of America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008135</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:17.599Z</lastUpdated>
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    <tradeName>Pediatric Mask with Adaptor</tradeName>
    <deviceName>Pediatric Mask with Adaptor</deviceName>
    <manufacturerName>PENTAX of America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008135</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
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    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6606</reference>
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    <lastUpdated>2026-07-01T21:59:16.785Z</lastUpdated>
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    <tradeName>Adult Face Mask, Extra</tradeName>
    <deviceName>Adult Face Mask, Extra</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>MDR 2017/745</legislation>
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    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:15.996Z</lastUpdated>
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    <basicUdiDi>496133303A6601V3</basicUdiDi>
    <tradeName>Flowhead, Extra</tradeName>
    <deviceName>Flowhead, Extra</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:15.192Z</lastUpdated>
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    <udiDi>04961333229918</udiDi>
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    <tradeName>Intra‑Oral Tubes</tradeName>
    <deviceName>Intra‑Oral Tubes</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>MDR 2017/745</legislation>
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    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6611</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:14.409Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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    <basicUdiDi>4961333010512Y5</basicUdiDi>
    <tradeName>Single Use, Sterile Distal End Cap with Elevator OE-A65</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
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    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <reference>6217001A064S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <manufacturerName>HOYA Corporation</manufacturerName>
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    <emdnDescription></emdnDescription>
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    <tradeName>PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits CS5522A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
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    <emdnDescription></emdnDescription>
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    <tradeName>Cleaning Brush CS6021SN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
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    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
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    <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>
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    <tradeName>Cleaning Brush CS3010S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
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    <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>
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