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    <tradeName>AMSure® Foley Catheter Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS89816H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:00:46.603Z</lastUpdated>
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    <udiDi>10704411014645</udiDi>
    <basicUdiDi>B-10704411014645</basicUdiDi>
    <tradeName>AMSure® Foley Catheter Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:00:40.999Z</lastUpdated>
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    <udiDi>10704411007623</udiDi>
    <basicUdiDi>B-10704411007623</basicUdiDi>
    <tradeName>AMSure® Foley Insertion Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:53:12.893Z</lastUpdated>
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    <basicUdiDi>B-10704411007616</basicUdiDi>
    <tradeName>AMSure® Foley Insertion Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS880K</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:53:12.094Z</lastUpdated>
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    <udiDi>10704411007609</udiDi>
    <basicUdiDi>B-10704411007609</basicUdiDi>
    <tradeName>AMSure® Urethral Catheterization Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS870K</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:53:11.285Z</lastUpdated>
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    <udiDi>10704411007593</udiDi>
    <basicUdiDi>B-10704411007593</basicUdiDi>
    <tradeName>AMSure® Urethral Self Catheterization Kit</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS85016K</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:53:10.475Z</lastUpdated>
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    <udiDi>10704411007586</udiDi>
    <basicUdiDi>B-10704411007586</basicUdiDi>
    <tradeName>AMSure® Urethral Self Catheterization Kit</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS85014K</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:53:07.369Z</lastUpdated>
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    <udiDi>10704411007579</udiDi>
    <basicUdiDi>B-10704411007579</basicUdiDi>
    <tradeName>AMSure® Urethral Self Catheterization Kit</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS85012K</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:53:07.367Z</lastUpdated>
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    <udiDi>10704411007562</udiDi>
    <basicUdiDi>B-10704411007562</basicUdiDi>
    <tradeName>AMSure® Urethral Self Catheterization Kit</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS85010K</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:53:06.428Z</lastUpdated>
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    <udiDi>10704411007555</udiDi>
    <basicUdiDi>B-10704411007555</basicUdiDi>
    <tradeName>AMSure® Urethral Self Catheterization Kit</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS85008K</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:53:05.023Z</lastUpdated>
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    <udiDi>10704411007548</udiDi>
    <basicUdiDi>B-10704411007548</basicUdiDi>
    <tradeName>AMSure® Pre-Connected Urethral Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS89214RK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:53:00.075Z</lastUpdated>
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    <udiDi>10704411007531</udiDi>
    <basicUdiDi>B-10704411007531</basicUdiDi>
    <tradeName>AMSure® Pre-Connected Urethral Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS89216RK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:58.602Z</lastUpdated>
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    <udiDi>10704411007524</udiDi>
    <basicUdiDi>B-10704411007524</basicUdiDi>
    <tradeName>AMSure® Urethral Catheterization Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS87114K</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:57.669Z</lastUpdated>
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    <udiDi>10704411007241</udiDi>
    <basicUdiDi>B-10704411007241</basicUdiDi>
    <tradeName>AMSure® Add-A-Foley Catheter Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS89330</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:36.236Z</lastUpdated>
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    <udiDi>10704411005322</udiDi>
    <basicUdiDi>B-10704411005322</basicUdiDi>
    <tradeName>AMSure® Foley Catheter Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS89318S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:09.589Z</lastUpdated>
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    <udiDi>10704411005315</udiDi>
    <basicUdiDi>B-10704411005315</basicUdiDi>
    <tradeName>AMSure® Foley Catheter Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS89316S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:08.573Z</lastUpdated>
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    <udiDi>10704411005308</udiDi>
    <basicUdiDi>B-10704411005308</basicUdiDi>
    <tradeName>AMSure® Foley Catheter Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS89314S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:05.619Z</lastUpdated>
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    <tradeName>AMSure® Foley Catheter Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS89318</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:51:19.762Z</lastUpdated>
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    <basicUdiDi>B-10704411003823</basicUdiDi>
    <tradeName>AMSure® Foley Catheter Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS89314</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:51:19.362Z</lastUpdated>
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    <basicUdiDi>B-10704411003830</basicUdiDi>
    <tradeName>AMSure® Foley Catheter Tray</tradeName>
    <deviceName>Urinary Catheterization/ Collection Kit</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U99</emdnCode>
    <emdnDescription>DEVICES FOR UROGENITAL SYSTEM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS89316</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:51:19.360Z</lastUpdated>
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