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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>
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    <reference>6651</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:46.482Z</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>
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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>
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    <emdnDescription>IMAGE ACQUISITION MODULES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9380</reference>
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    <lastUpdated>2026-07-01T21:59:42.466Z</lastUpdated>
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    <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></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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    <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></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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    <udiDi>04961333235445</udiDi>
    <basicUdiDi>4961333034500bSG</basicUdiDi>
    <tradeName>Computerized Speech Lab (CSL) 4500b</tradeName>
    <deviceName>Computerized Speech Lab (CSL) 4500b</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>4500b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:36.050Z</lastUpdated>
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    <udiDi>04961333235438</udiDi>
    <basicUdiDi>4961333033950cTU</basicUdiDi>
    <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></emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3950c</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:35.272Z</lastUpdated>
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    <udiDi>04961333231553</udiDi>
    <basicUdiDi>496133303A7190VA</basicUdiDi>
    <tradeName>Switch Box Assembly A‑B</tradeName>
    <deviceName>Switch Box Assembly A‑B</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>7190‑2500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:34.451Z</lastUpdated>
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    <udiDi>04961333236565</udiDi>
    <basicUdiDi>496133303660026</basicUdiDi>
    <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></emdnCode>
    <emdnDescription>VOICE DISPLAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6600WU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:33.653Z</lastUpdated>
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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>
    <emdnCode></emdnCode>
    <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>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6615</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:18.387Z</lastUpdated>
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    <udiDi>04961333230105</udiDi>
    <basicUdiDi>496133303A6610V4</basicUdiDi>
    <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>
    <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>6610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:17.599Z</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></emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6606</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:59:16.785Z</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>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <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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    <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></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>
    <basicUdiDi>496133303A6611V6</basicUdiDi>
    <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></emdnCode>
    <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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    <udiDi>04961333230112</udiDi>
    <basicUdiDi>496133303A6611V6</basicUdiDi>
    <tradeName>Screening Tubes</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6612</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.086Z</lastUpdated>
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    <udiDi>04961333230129</udiDi>
    <basicUdiDi>496133303A6610V4</basicUdiDi>
    <tradeName>Airflow Head‑Mask Couplers</tradeName>
    <deviceName></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></emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6613</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.067Z</lastUpdated>
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    <basicUdiDi>496133303A6611V6</basicUdiDi>
    <tradeName>Pressure Port Tubes</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6614</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.048Z</lastUpdated>
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    <udiDi>04961333230501</udiDi>
    <basicUdiDi>496133303A6611V6</basicUdiDi>
    <tradeName>Flowhead Tubes</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7189‑4200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:50.027Z</lastUpdated>
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