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    <tradeName>PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U</tradeName>
    <deviceName>PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U</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>Z12020802</emdnCode>
    <emdnDescription>VIDEO BRONCHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333225583</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:43.218Z</lastUpdated>
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    <udiDi>04961333225255</udiDi>
    <basicUdiDi>B-04961333225255</basicUdiDi>
    <tradeName>PENTAX Medical Video Processor EPK-3000</tradeName>
    <deviceName>PENTAX Medical Video Processor EPK-3000</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>Z12020406</emdnCode>
    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333225255</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:42.430Z</lastUpdated>
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    <udiDi>04961333223619</udiDi>
    <basicUdiDi>B-04961333223619</basicUdiDi>
    <tradeName>PENTAX Medical Electro-Surgical Knife DN-D Series</tradeName>
    <deviceName>PENTAXMedical Electro-Surgical Knife DN-D Series DN-D2722B</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>MDD</legislation>
    <emdnCode>G030899</emdnCode>
    <emdnDescription>INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333223619</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:41.647Z</lastUpdated>
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    <udiDi>04961333223589</udiDi>
    <basicUdiDi>B-04961333223589</basicUdiDi>
    <tradeName>PENTAX Medical Electro-Surgical Knife DN-D Series</tradeName>
    <deviceName>PENTAXMedical Electro-Surgical Knife DN-D Series DN-D2718B</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>MDD</legislation>
    <emdnCode>G030899</emdnCode>
    <emdnDescription>INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333223589</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:37.623Z</lastUpdated>
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    <udiDi>04961333146062</udiDi>
    <basicUdiDi>B-04961333146062</basicUdiDi>
    <tradeName>PENTAX Balloon OE-A52</tradeName>
    <deviceName>PENTAX Balloon OE-A52</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>MDD</legislation>
    <emdnCode>G0380</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333146062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:36.835Z</lastUpdated>
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    <udiDi>04961333123339</udiDi>
    <basicUdiDi>B-04961333123339</basicUdiDi>
    <tradeName>BALLOON</tradeName>
    <deviceName>BALLOON OE-A51</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>MDD</legislation>
    <emdnCode>G0380</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333123339</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:36.019Z</lastUpdated>
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    <udiDi>04961333255979</udiDi>
    <basicUdiDi>496133303A6651VJ</basicUdiDi>
    <tradeName>Microphone Assembly Kit</tradeName>
    <deviceName>Microphone Assembly Kit</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>6651</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:28.833Z</lastUpdated>
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    <udiDi>04961333255016</udiDi>
    <basicUdiDi>49613330395002N</basicUdiDi>
    <tradeName>LARYNGEAL STROBE 9500</tradeName>
    <deviceName>LARYNGOSTROBOSCOPE</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>Z12021010</emdnCode>
    <emdnDescription>LARYNGOSTROBOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:28.030Z</lastUpdated>
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    <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>G0380</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001A097</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:27.237Z</lastUpdated>
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    <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>G0380</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001A085S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:26.429Z</lastUpdated>
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    <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>Z12020510</emdnCode>
    <emdnDescription>VIDEO GASTRODUODENOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S339S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:22.425Z</lastUpdated>
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    <udiDi>04961333248117</udiDi>
    <basicUdiDi>496133303938034</basicUdiDi>
    <tradeName>Digital Capture</tradeName>
    <deviceName>Digital Capture</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>Z119007</emdnCode>
    <emdnDescription>IMAGE ACQUISITION MODULES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9380</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:21.630Z</lastUpdated>
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    <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>Z12020406</emdnCode>
    <emdnDescription>VIDEO PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001P225S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:20.825Z</lastUpdated>
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    <udiDi>04961333247318</udiDi>
    <basicUdiDi>4961333036500ZW</basicUdiDi>
    <tradeName>Nasometer</tradeName>
    <deviceName>Nasometer</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>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:20.016Z</lastUpdated>
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    <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>Z12020509</emdnCode>
    <emdnDescription>VIDEO OESOPHAGOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S257S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:16.014Z</lastUpdated>
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    <udiDi>04961333240685</udiDi>
    <basicUdiDi>49613330394002H</basicUdiDi>
    <tradeName>LARYNGEAL STROBE 9400</tradeName>
    <deviceName>9400 LARYNGOSTROBOSCOPE</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>Z12021010</emdnCode>
    <emdnDescription>LARYNGOSTROBOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:15.218Z</lastUpdated>
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    <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>Z12020503</emdnCode>
    <emdnDescription>ECHO–GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S207S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:14.413Z</lastUpdated>
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    <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>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S210S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:09.618Z</lastUpdated>
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    <tradeName>Phonatory Aerodynamic System (SOFTWARE)</tradeName>
    <deviceName>Phonatory Aerodynamic System (PAS)</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>Z12149010</emdnCode>
    <emdnDescription>VOICE DISPLAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6600WU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:08.819Z</lastUpdated>
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    <tradeName>3950c Visi-Pitch</tradeName>
    <deviceName>3950c Visi-Pitch</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>V030208</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3950c</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:28:08.020Z</lastUpdated>
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