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<eudamedExport entity="devices">
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    <udiDi>10704411007876</udiDi>
    <basicUdiDi>B-10704411007876</basicUdiDi>
    <tradeName>AMSure® Suction Catheter</tradeName>
    <deviceName>Suction catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS364</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:53:19.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411007869</udiDi>
    <basicUdiDi>B-10704411007869</basicUdiDi>
    <tradeName>AMSure® Suction Catheter</tradeName>
    <deviceName>Suction catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS363</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:53:18.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411007852</udiDi>
    <basicUdiDi>B-10704411007852</basicUdiDi>
    <tradeName>AMSure® Suction Catheter</tradeName>
    <deviceName>Suction catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS362</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:53:17.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411007845</udiDi>
    <basicUdiDi>B-10704411007845</basicUdiDi>
    <tradeName>AMSure® Suction Catheter</tradeName>
    <deviceName>Suction catheter</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS361</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:53:16.885Z</lastUpdated>
  </row>
  <row>
    <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>
    <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>AS890K</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:53:12.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411007616</udiDi>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>10704411007517</udiDi>
    <basicUdiDi>B-10704411007517</basicUdiDi>
    <tradeName>AMSure® Urine Drainage Bag</tradeName>
    <deviceName>Urine Bag</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06030301</emdnCode>
    <emdnDescription>URINE COLLECTION BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UB2000PP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:59.318Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>10704411007494</udiDi>
    <basicUdiDi>B-10704411007494</basicUdiDi>
    <tradeName>AMSure® Pre-Filled Syringe for Balloon Inflation with Sterile Water</tradeName>
    <deviceName>Pre-filled syringe</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010702</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE WATER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIS1005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:53.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411007487</udiDi>
    <basicUdiDi>B-10704411007487</basicUdiDi>
    <tradeName>AMSure® Pre-Filled Syringe for Balloon Inflation with Sterile Water</tradeName>
    <deviceName>Pre-filled syringe</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010702</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE WATER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIS1003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:41.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411007470</udiDi>
    <basicUdiDi>B-10704411007470</basicUdiDi>
    <tradeName>AMSure® Pre-Filled Syringe for Balloon Inflation with Sterile Water</tradeName>
    <deviceName>Pre-filled syringe</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010702</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE WATER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIS1010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:40.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411007463</udiDi>
    <basicUdiDi>B-10704411007463</basicUdiDi>
    <tradeName>AMSure® Pre-Filled Syringe for Balloon Inflation with Sterile Water</tradeName>
    <deviceName>Pre-filled syringe</deviceName>
    <manufacturerName>Amsino International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010702</emdnCode>
    <emdnDescription>PREFILLED SYRINGES WITH STERILE WATER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIS3530</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:37.611Z</lastUpdated>
  </row>
</eudamedExport>