<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <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>
  </row>
  <row>
    <udiDi>10704411007173</udiDi>
    <basicUdiDi>B-10704411007173</basicUdiDi>
    <tradeName>AMSINO Sure-Lok™ Needle-Free Connector</tradeName>
    <deviceName>Needleless Connector</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>A070103</emdnCode>
    <emdnDescription>INFUSION TUBING ADAPTERS AND CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AY0200S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:35.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411007166</udiDi>
    <basicUdiDi>B-10704411007166</basicUdiDi>
    <tradeName>AMSafe® I.V. Administration Set</tradeName>
    <deviceName>Intravenous Administration Set and Accessories</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>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABL006G-LND</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:33.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411007081</udiDi>
    <basicUdiDi>B-10704411007081</basicUdiDi>
    <tradeName>AMSure® Enteral Feeding Flat Top Piston Syringe</tradeName>
    <deviceName>Enteral feeding 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>A020108</emdnCode>
    <emdnDescription>ENTERAL FEEDING SYRINGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENS115</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:31.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411007074</udiDi>
    <basicUdiDi>B-10704411007074</basicUdiDi>
    <tradeName>AMSure® Enteral Feeding Thumb Control Ring Syringe</tradeName>
    <deviceName>Enteral feeding 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>A020108</emdnCode>
    <emdnDescription>ENTERAL FEEDING SYRINGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENS015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:29.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411006558</udiDi>
    <basicUdiDi>B-10704411006558</basicUdiDi>
    <tradeName>AMSure® Enteral Administration Kit</tradeName>
    <deviceName>Enteral Delivery Pump set</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>A080101</emdnCode>
    <emdnDescription>ENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENF1200K</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:28.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411006541</udiDi>
    <basicUdiDi>B-10704411006541</basicUdiDi>
    <tradeName>AMSure® Enteral Administration Kit</tradeName>
    <deviceName>Enteral Delivery Pump set</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>A080101</emdnCode>
    <emdnDescription>ENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENF1004K</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:27.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411006534</udiDi>
    <basicUdiDi>B-10704411006534</basicUdiDi>
    <tradeName>AMSure® Enteral Administration Kit</tradeName>
    <deviceName>Enteral Delivery Pump set</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>A080101</emdnCode>
    <emdnDescription>ENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENF500K</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:24.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411006527</udiDi>
    <basicUdiDi>B-10704411006527</basicUdiDi>
    <tradeName>AMSure® ENTERAL FEEDING BAG with ATTACHED PUMP MAGNET SET</tradeName>
    <deviceName>Enteral Delivery Pump set</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>A080101</emdnCode>
    <emdnDescription>ENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES-1200M</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:23.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411006497</udiDi>
    <basicUdiDi>B-10704411006497</basicUdiDi>
    <tradeName>AMSure® ENTERAL FEEDING BAG with ATTACHED PUMP SET</tradeName>
    <deviceName>Enteral Delivery Pump set</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>A080101</emdnCode>
    <emdnDescription>ENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-1200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:22.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411006404</udiDi>
    <basicUdiDi>B-10704411006404</basicUdiDi>
    <tradeName>AMSure® Tracheostomy Care Tray</tradeName>
    <deviceName>Tracheostomy Care Tray</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>M040203</emdnCode>
    <emdnDescription>TRACHEOSTOMY DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS861</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:21.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411006398</udiDi>
    <basicUdiDi>B-10704411006398</basicUdiDi>
    <tradeName>AMSure® Tracheostomy Care Tray</tradeName>
    <deviceName>Tracheostomy Care Tray</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>M040203</emdnCode>
    <emdnDescription>TRACHEOSTOMY DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS860</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:18.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411006121</udiDi>
    <basicUdiDi>B-10704411006121</basicUdiDi>
    <tradeName>AMSafe® Burette Set</tradeName>
    <deviceName>Infusion Set with Burette</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>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP2089MR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:16.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411006060</udiDi>
    <basicUdiDi>B-10704411006060</basicUdiDi>
    <tradeName>AMSINO I.V. Administration Set</tradeName>
    <deviceName>Intravenous Administration Set and Accessories</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>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABL006SI-PND</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:15.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411005728</udiDi>
    <basicUdiDi>B-10704411005728</basicUdiDi>
    <tradeName>AMSure® Suction connecting tube</tradeName>
    <deviceName>Suction connecting tube</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>A060102</emdnCode>
    <emdnDescription>SURGICAL DRAINAGE CONNECTION MEDICAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS826C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:14.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411005490</udiDi>
    <basicUdiDi>B-10704411005490</basicUdiDi>
    <tradeName>AMSure® Urine Meter Drainage Bag</tradeName>
    <deviceName>Urine Meter</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>AS327200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:12.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411005476</udiDi>
    <basicUdiDi>B-10704411005476</basicUdiDi>
    <tradeName>AMSure® TUR/Bladder Irrigation Set Y-Type</tradeName>
    <deviceName>Bladder Irrigation Set</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>A03040201</emdnCode>
    <emdnDescription>BLADDER IRRIGATION KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABL402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:10.604Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
    <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>AS89316S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:08.573Z</lastUpdated>
  </row>
  <row>
    <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>
    <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>AS89314S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:05.619Z</lastUpdated>
  </row>
</eudamedExport>