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    <tradeName>Switch Box Assembly A‑B</tradeName>
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    <tradeName>Adult Small Disposable Masks</tradeName>
    <deviceName>Adult Small Disposable Masks</deviceName>
    <manufacturerName>PENTAX of America Inc.</manufacturerName>
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    <basicUdiDi>496133303A6615VE</basicUdiDi>
    <tradeName>Pediatric Disposable Masks</tradeName>
    <deviceName>Pediatric Disposable Masks</deviceName>
    <manufacturerName>PENTAX of America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008135</manufacturerSrn>
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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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    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:01.607Z</lastUpdated>
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    <udiDi>04961333230099</udiDi>
    <basicUdiDi>496133303A6606VD</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6606</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:00.820Z</lastUpdated>
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    <udiDi>04961333230082</udiDi>
    <basicUdiDi>496133303A6602V5</basicUdiDi>
    <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>
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    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:27:56.812Z</lastUpdated>
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    <udiDi>04961333230075</udiDi>
    <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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:27:56.010Z</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>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6611</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:27:55.215Z</lastUpdated>
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    <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>Z12020802</emdnCode>
    <emdnDescription>VIDEO BRONCHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S031S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:27:54.439Z</lastUpdated>
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    <udiDi>04961333070459</udiDi>
    <basicUdiDi>4961333010509YG</basicUdiDi>
    <tradeName>Channel Cleaning Adapter OF-B115</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>6217001Z726S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:27:50.415Z</lastUpdated>
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    <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>V070101</emdnCode>
    <emdnDescription>ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001Z638S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:27:49.607Z</lastUpdated>
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    <basicUdiDi>B-04961333252695</basicUdiDi>
    <tradeName>PENTAX VIDEO UPPER G.I. SCOPE EG29-i10</tradeName>
    <deviceName>PENTAX VIDEO UPPER G.I. SCOPE EG29-i10</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>MDD</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333252695</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:38:14.214Z</lastUpdated>
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    <udiDi>04961333252305</udiDi>
    <basicUdiDi>B-04961333252305</basicUdiDi>
    <tradeName>VIDEO UPPER G.I. SCOPE EG-2990i</tradeName>
    <deviceName>VIDEO UPPER G.I. SCOPE EG-2990i</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>MDD</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333252305</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:38:07.016Z</lastUpdated>
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    <basicUdiDi>B-04961333251070</basicUdiDi>
    <tradeName>PENTAX GAS/WATER FEEDING VALVE OF-B194</tradeName>
    <deviceName>PENTAX GAS/WATER FEEDING VALVE OF-B194</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>MDD</legislation>
    <emdnCode>G0380</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333251070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:38:06.218Z</lastUpdated>
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    <udiDi>04961333251032</udiDi>
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    <tradeName>PENTAX WATER BOTTLE</tradeName>
    <deviceName>PENTAX WATER BOTTLE OS-H5</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333251032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:38:02.210Z</lastUpdated>
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    <udiDi>04961333246205</udiDi>
    <basicUdiDi>B-04961333246205</basicUdiDi>
    <tradeName>PENTAX Medical Video Duodenoscope ED32-i10</tradeName>
    <deviceName>PENTAX Medical Video Duodenoscope ED32-i10</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333246205</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:38:01.408Z</lastUpdated>
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    <basicUdiDi>B-04961333240036</basicUdiDi>
    <tradeName>GASTRO FIBERSCOPE FG-24V</tradeName>
    <deviceName>GASTRO FIBERSCOPE FG-24V</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>Z12020506</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333240036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:38:00.616Z</lastUpdated>
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    <tradeName>PENTAX Medical Video Upper GI Scope EG34-i10</tradeName>
    <deviceName>PENTAX Medical Video Upper GI Scope EG34-i10</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
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    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
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    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333240012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:38:00.304Z</lastUpdated>
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    <tradeName>PENTAX VIDEO UPPER G.I. SCOPE EG-2790K</tradeName>
    <deviceName>PENTAX VIDEO UPPER G.I. SCOPE EG-2790K</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
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    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333239986</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:55.815Z</lastUpdated>
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    <tradeName>PORTABLE INTUBATIONSCOPE FI-BS SERIES</tradeName>
    <deviceName>PORTABLE INTUBATIONSCOPE FI-BS SERIES FI-7RBS</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>MDD</legislation>
    <emdnCode>Z12029006</emdnCode>
    <emdnDescription>FIBROSCOPES FOR INTUBATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333239054</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:26.141Z</lastUpdated>
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