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    <tradeName>VERSA</tradeName>
    <deviceName>PENTAX Medical Video Colonoscope</deviceName>
    <manufacturerName>PENTAX-Aohua Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005686</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020606</emdnCode>
    <emdnDescription>VIDEO COLONOSCOPES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>EC38-V12cM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:42:00.890Z</lastUpdated>
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    <tradeName>VERSA</tradeName>
    <deviceName>PENTAX Medical Video Gastroscope</deviceName>
    <manufacturerName>PENTAX-Aohua Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005686</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>EG29-V12c</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:41:58.491Z</lastUpdated>
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    <basicUdiDi>697227211ENY3</basicUdiDi>
    <tradeName>VERSA</tradeName>
    <deviceName>PENTAX Medical Video Laryngoscope</deviceName>
    <manufacturerName>PENTAX-Aohua Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005686</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12021004</emdnCode>
    <emdnDescription>VIDEO LARYNGOSCOPES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>EN11-V10c</reference>
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    <tradeName>VERSA</tradeName>
    <deviceName>PENTAX Medical Endoscopic Trolley</deviceName>
    <manufacturerName>PENTAX-Aohua Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005686</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12029003</emdnCode>
    <emdnDescription>ENDOSCOPE TRANSPORT CARTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT-V10c</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:41:56.084Z</lastUpdated>
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    <basicUdiDi>697227211EBXB</basicUdiDi>
    <tradeName>VERSA</tradeName>
    <deviceName>PENTAX Medical Video Bronchoscope</deviceName>
    <manufacturerName>PENTAX-Aohua Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005686</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>AB pazarı için değil</deviceStatus>
    <reference>EB11-V10c</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:41:53.696Z</lastUpdated>
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    <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>
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    <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>
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    <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></emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6651</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:46.482Z</lastUpdated>
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    <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></emdnCode>
    <emdnDescription>LARYNGOSTROBOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:45.674Z</lastUpdated>
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    <udiDi>04961333254620</udiDi>
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    <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>
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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></emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001A085S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:44.061Z</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></emdnCode>
    <emdnDescription>VIDEO GASTRODUODENOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6217001S339S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:43.250Z</lastUpdated>
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    <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></emdnCode>
    <emdnDescription>IMAGE ACQUISITION MODULES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9380</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:42.466Z</lastUpdated>
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    <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>
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    <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></emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:40.852Z</lastUpdated>
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    <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>
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    <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>
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    <manufacturerName>PENTAX of America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008135</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LARYNGOSTROBOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:39.250Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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