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    <tradeName>00848106000414</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1422SRL9</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.795Z</lastUpdated>
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    <udiDi>00848106000438</udiDi>
    <basicUdiDi>08481060VIS500F9</basicUdiDi>
    <tradeName>00848106000438</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1449XLSR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.775Z</lastUpdated>
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    <udiDi>00848106000483</udiDi>
    <basicUdiDi>08481060VIS510FC</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1448XL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.757Z</lastUpdated>
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    <udiDi>00848106000490</udiDi>
    <basicUdiDi>08481060VIS510FC</basicUdiDi>
    <tradeName>00848106000490</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1449XL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.739Z</lastUpdated>
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    <udiDi>00848106001152</udiDi>
    <basicUdiDi>08481060VIS500F9</basicUdiDi>
    <tradeName>00848106001152</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1438SR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.716Z</lastUpdated>
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    <udiDi>00848106001213</udiDi>
    <basicUdiDi>08481060VIS500F9</basicUdiDi>
    <tradeName>00848106001213</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1447XLGSR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.694Z</lastUpdated>
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    <udiDi>00848106001220</udiDi>
    <basicUdiDi>08481060VIS500F9</basicUdiDi>
    <tradeName>00848106001220</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1453SRL9</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.668Z</lastUpdated>
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    <udiDi>00848106001367</udiDi>
    <basicUdiDi>08481060VIS510FC</basicUdiDi>
    <tradeName>00848106001367</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.645Z</lastUpdated>
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    <udiDi>00848106001404</udiDi>
    <basicUdiDi>08481060VIS510FC</basicUdiDi>
    <tradeName>00848106001404</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1403</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.624Z</lastUpdated>
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    <udiDi>00848106001411</udiDi>
    <basicUdiDi>08481060VIS510FC</basicUdiDi>
    <tradeName>00848106001411</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1405</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.603Z</lastUpdated>
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    <udiDi>00848106001428</udiDi>
    <basicUdiDi>08481060VIS510FC</basicUdiDi>
    <tradeName>00848106001428</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1406</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.579Z</lastUpdated>
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    <udiDi>00848106001497</udiDi>
    <basicUdiDi>08481060VIS510FC</basicUdiDi>
    <tradeName>00848106001497</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1422</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.555Z</lastUpdated>
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    <udiDi>00848106001534</udiDi>
    <basicUdiDi>08481060VIS510FC</basicUdiDi>
    <tradeName>00848106001534</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1424</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.531Z</lastUpdated>
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    <udiDi>00848106001541</udiDi>
    <basicUdiDi>08481060VIS510FC</basicUdiDi>
    <tradeName>00848106001541</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1425</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.509Z</lastUpdated>
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    <udiDi>00848106001565</udiDi>
    <basicUdiDi>08481060VIS510FC</basicUdiDi>
    <tradeName>00848106001565</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1436</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.488Z</lastUpdated>
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    <udiDi>00848106001572</udiDi>
    <basicUdiDi>08481060VIS510FC</basicUdiDi>
    <tradeName>00848106001572</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1437</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.462Z</lastUpdated>
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    <udiDi>00848106001602</udiDi>
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    <tradeName>00848106001602</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1440</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.438Z</lastUpdated>
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    <udiDi>00848106001626</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1444</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.414Z</lastUpdated>
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    <udiDi>00848106001633</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1445</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.392Z</lastUpdated>
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    <udiDi>00848106001664</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Viscot Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000029821</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1447XLG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:00.371Z</lastUpdated>
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