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    <manufacturerName>American Diagnostic Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000021544</manufacturerSrn>
    <authorisedRepresentativeName>S.C. Cattus S.R.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>RO-AR-000020096</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <reference>5111NL</reference>
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    <lastUpdated>2026-06-22T13:25:32.113Z</lastUpdated>
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    <tradeName>Diagnostix™</tradeName>
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    <manufacturerName>American Diagnostic Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000021544</manufacturerSrn>
    <authorisedRepresentativeName>S.C. Cattus S.R.L.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>5120NLV-02</reference>
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    <lastUpdated>2026-06-22T13:25:31.013Z</lastUpdated>
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    <basicUdiDi>063478256105680H4</basicUdiDi>
    <tradeName>Diagnostix™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>American Diagnostic Corporation</manufacturerName>
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    <authorisedRepresentativeName>S.C. Cattus S.R.L.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>5680L-36L</reference>
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    <lastUpdated>2026-06-22T13:25:30.881Z</lastUpdated>
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    <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>Z12149080</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>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149080</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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    <udiDi>04961333230136</udiDi>
    <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>Z12149080</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>Z12149080</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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    <tradeName>Adult Small Disposable Masks</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6635</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.976Z</lastUpdated>
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    <udiDi>04961333231065</udiDi>
    <basicUdiDi>496133303A6625VH</basicUdiDi>
    <tradeName>Adult Large Disposable Masks</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6645</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.956Z</lastUpdated>
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    <udiDi>04961333247424</udiDi>
    <basicUdiDi>496133303660026</basicUdiDi>
    <tradeName>Phonatory Aerodynamic System (PAS)</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>Z12149010</emdnCode>
    <emdnDescription>ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:49.381Z</lastUpdated>
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    <udiDi>04961333255986</udiDi>
    <basicUdiDi>496133303A6611V6</basicUdiDi>
    <tradeName>PAS Tubing Kit</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>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6650</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:48.760Z</lastUpdated>
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    <basicUdiDi>8964003248FS0373</basicUdiDi>
    <tradeName>Otoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SG Manufacturers</manufacturerName>
    <manufacturerSrn>PK-MF-000007106</manufacturerSrn>
    <authorisedRepresentativeName>International Business Compendious of Sweden</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001625</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FMO-001-7000-90.02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:44:14.858Z</lastUpdated>
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    <udiDi>08964003248666</udiDi>
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    <tradeName>Otoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SG Manufacturers</manufacturerName>
    <manufacturerSrn>PK-MF-000007106</manufacturerSrn>
    <authorisedRepresentativeName>International Business Compendious of Sweden</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001625</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FMO-001-7000-90.03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:44:14.840Z</lastUpdated>
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    <tradeName>Otoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SG Manufacturers</manufacturerName>
    <manufacturerSrn>PK-MF-000007106</manufacturerSrn>
    <authorisedRepresentativeName>International Business Compendious of Sweden</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001625</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FMO-001-7000-90.04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:44:14.814Z</lastUpdated>
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    <tradeName>Otoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SG Manufacturers</manufacturerName>
    <manufacturerSrn>PK-MF-000007106</manufacturerSrn>
    <authorisedRepresentativeName>International Business Compendious of Sweden</authorisedRepresentativeName>
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    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FMO-001-7000-90.05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:44:14.794Z</lastUpdated>
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    <tradeName>Otoscope</tradeName>
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    <manufacturerName>SG Manufacturers</manufacturerName>
    <manufacturerSrn>PK-MF-000007106</manufacturerSrn>
    <authorisedRepresentativeName>International Business Compendious of Sweden</authorisedRepresentativeName>
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    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FMO-001-7000-90.06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:44:14.774Z</lastUpdated>
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    <tradeName>Otoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SG Manufacturers</manufacturerName>
    <manufacturerSrn>PK-MF-000007106</manufacturerSrn>
    <authorisedRepresentativeName>International Business Compendious of Sweden</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001625</authorisedRepresentativeSrn>
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    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FMO-001-7000-95.01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:44:14.752Z</lastUpdated>
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    <tradeName>Otoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SG Manufacturers</manufacturerName>
    <manufacturerSrn>PK-MF-000007106</manufacturerSrn>
    <authorisedRepresentativeName>International Business Compendious of Sweden</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001625</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FMO-001-7000-95.02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:44:14.734Z</lastUpdated>
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    <tradeName>Otoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SG Manufacturers</manufacturerName>
    <manufacturerSrn>PK-MF-000007106</manufacturerSrn>
    <authorisedRepresentativeName>International Business Compendious of Sweden</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
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    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FMO-001-7000-95.03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:44:14.717Z</lastUpdated>
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    <udiDi>08964003248734</udiDi>
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    <tradeName>Otoscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SG Manufacturers</manufacturerName>
    <manufacturerSrn>PK-MF-000007106</manufacturerSrn>
    <authorisedRepresentativeName>International Business Compendious of Sweden</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001625</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FMO-001-7000-95.04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:44:14.702Z</lastUpdated>
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