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    <tradeName>BITE BLOCK OF-Z5</tradeName>
    <deviceName>BITE BLOCK</deviceName>
    <manufacturerName>PENTAX Medical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>G030804</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>04961333071067</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-04T18:33:16.262Z</lastUpdated>
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    <udiDi>04961333070541</udiDi>
    <basicUdiDi>4961333010502Y2</basicUdiDi>
    <tradeName>SOAKING CAP BS-B1</tradeName>
    <deviceName>SOAKING CAP</deviceName>
    <manufacturerName>PENTAX Medical 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>Artık piyasada değil</deviceStatus>
    <reference>04961333070541</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-04T18:33:15.457Z</lastUpdated>
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    <udiDi>04961333070367</udiDi>
    <basicUdiDi>4961333010504Y6</basicUdiDi>
    <tradeName>ETO VENTING CAP OF-C5</tradeName>
    <deviceName>ETO VENTING CAP</deviceName>
    <manufacturerName>PENTAX Medical 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>Artık piyasada değil</deviceStatus>
    <reference>04961333070367</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-04T18:33:11.467Z</lastUpdated>
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    <udiDi>04961333118373</udiDi>
    <basicUdiDi>4961333010501XY</basicUdiDi>
    <tradeName>Adapter for Other's Fiber to P-Light AL-SF2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PENTAX Medical 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>Artık piyasada değil</deviceStatus>
    <reference>04961333118373</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T20:00:07.486Z</lastUpdated>
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    <udiDi>04961333147335</udiDi>
    <basicUdiDi>4961333010502Y2</basicUdiDi>
    <tradeName>LIGHT GUIDE PLUG CAP OE-C23</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PENTAX Medical 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>Artık piyasada değil</deviceStatus>
    <reference>04961333147335</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T20:00:00.817Z</lastUpdated>
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    <udiDi>04961333222407</udiDi>
    <basicUdiDi>4961333010502Y2</basicUdiDi>
    <tradeName>Soaking Cap OE-C27</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PENTAX Medical 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>Artık piyasada değil</deviceStatus>
    <reference>04961333222407</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T20:00:00.778Z</lastUpdated>
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    <udiDi>04961333123346</udiDi>
    <basicUdiDi>4961333010502Y2</basicUdiDi>
    <tradeName>Soaking Cap for US Connector OE-U1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PENTAX Medical 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>Artık piyasada değil</deviceStatus>
    <reference>04961333123346</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T20:00:00.748Z</lastUpdated>
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    <udiDi>04961333222223</udiDi>
    <basicUdiDi>4961333010502Y2</basicUdiDi>
    <tradeName>Scanning Unit Connector Soaking Cap OE-U4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PENTAX Medical 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>Artık piyasada değil</deviceStatus>
    <reference>04961333222223</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T20:00:00.714Z</lastUpdated>
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    <udiDi>04961333246304</udiDi>
    <basicUdiDi>4961333010114XM</basicUdiDi>
    <tradeName>PENTAX Medical Camera Head PVK-J10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PENTAX Medical 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>Z12020480</emdnCode>
    <emdnDescription>INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>04961333246304</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T03:36:21.369Z</lastUpdated>
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    <udiDi>04961333246342</udiDi>
    <basicUdiDi>4961333010508YE</basicUdiDi>
    <tradeName>Leakage Tester SHA-P6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PENTAX Medical 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>Artık piyasada değil</deviceStatus>
    <reference>04961333246342</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T03:36:21.282Z</lastUpdated>
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    <udiDi>04961333249268</udiDi>
    <basicUdiDi>B-04961333249268</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>04961333249268</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:50.410Z</lastUpdated>
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    <udiDi>04961333249169</udiDi>
    <basicUdiDi>B-04961333249169</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>04961333249169</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:49.640Z</lastUpdated>
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    <udiDi>04961333239757</udiDi>
    <basicUdiDi>B-04961333239757</basicUdiDi>
    <tradeName>PENTAX Medical Single Use Balloon OE-A60</tradeName>
    <deviceName>PENTAX Medical Single Use Balloon OE-A60</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>04961333239757</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:48.826Z</lastUpdated>
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    <udiDi>04961333233700</udiDi>
    <basicUdiDi>B-04961333233700</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>04961333233700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:48.006Z</lastUpdated>
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    <udiDi>04961333232895</udiDi>
    <basicUdiDi>B-04961333232895</basicUdiDi>
    <tradeName>PENTAX Medical Video PROCESSOR EPK-i5500c</tradeName>
    <deviceName>PENTAX Medical Video PROCESSOR EPK-i5500c</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>Z12021006</emdnCode>
    <emdnDescription>VIDEO NASOPHARYNGO/LARYNGOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333232895</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:23:44.027Z</lastUpdated>
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    <udiDi>04961333225583</udiDi>
    <basicUdiDi>B-04961333225583</basicUdiDi>
    <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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