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<eudamedExport entity="devices">
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    <udiDi>10704411016519</udiDi>
    <basicUdiDi>B-10704411016519</basicUdiDi>
    <tradeName>AMSafe® Standardbore Extension 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>IVE1500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:21.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411016502</udiDi>
    <basicUdiDi>B-10704411016502</basicUdiDi>
    <tradeName>AMSafe® Standardbore Extension 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>IVE1001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:20.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411016441</udiDi>
    <basicUdiDi>B-10704411016441</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>209602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:19.903Z</lastUpdated>
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  <row>
    <udiDi>10704411016410</udiDi>
    <basicUdiDi>B-10704411016410</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>AFS110</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:19.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411016373</udiDi>
    <basicUdiDi>B-10704411016373</basicUdiDi>
    <tradeName>AMSafe® Needleless Blood or Solution Admin Set</tradeName>
    <deviceName>Blood Transfusion 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>B99</emdnCode>
    <emdnDescription>HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2114</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:14.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411016304</udiDi>
    <basicUdiDi>B-10704411016304</basicUdiDi>
    <tradeName>AMSafe® Extension 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>AE3602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:14.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411016144</udiDi>
    <basicUdiDi>B-10704411016144</basicUdiDi>
    <tradeName>AMSure® Enteral Delivery 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>ENF1005C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:14.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411016106</udiDi>
    <basicUdiDi>B-10704411016106</basicUdiDi>
    <tradeName>AMSure® Cystoscopy/Bladder Irrigation Set</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>ABL400</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:12.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411016090</udiDi>
    <basicUdiDi>B-10704411016090</basicUdiDi>
    <tradeName>AMSure® Four Lead Bladder Irrigation Set</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>ABL404</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:08.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411015901</udiDi>
    <basicUdiDi>B-10704411015901</basicUdiDi>
    <tradeName>AMSure® Enteral Delivery Set with Two Spikes</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>EFPD0000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:07.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411015895</udiDi>
    <basicUdiDi>B-10704411015895</basicUdiDi>
    <tradeName>AMSure® Enteral Delivery Set with Two 1200mL Bag</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>EFPD1212</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:07.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411015888</udiDi>
    <basicUdiDi>B-10704411015888</basicUdiDi>
    <tradeName>AMSure® Enteral Delivery 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>ENF1200S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:06.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411015871</udiDi>
    <basicUdiDi>B-10704411015871</basicUdiDi>
    <tradeName>AMSure® Enteral Pump Spike 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>ENF1004S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:01.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411015864</udiDi>
    <basicUdiDi>B-10704411015864</basicUdiDi>
    <tradeName>AMSure® Hydrophilic Latex Foley Catheter</tradeName>
    <deviceName>Hydrophilic Foley 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020201</emdnCode>
    <emdnDescription>URETERAL CATHETERS FOR OCCLUSION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS43026H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:01.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411015857</udiDi>
    <basicUdiDi>B-10704411015857</basicUdiDi>
    <tradeName>AMSure® Hydrophilic Latex Foley Catheter</tradeName>
    <deviceName>Hydrophilic Foley 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020201</emdnCode>
    <emdnDescription>URETERAL CATHETERS FOR OCCLUSION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS43024H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:00.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411015840</udiDi>
    <basicUdiDi>B-10704411015840</basicUdiDi>
    <tradeName>AMSure® Hydrophilic Latex Foley Catheter</tradeName>
    <deviceName>Hydrophilic Foley 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020201</emdnCode>
    <emdnDescription>URETERAL CATHETERS FOR OCCLUSION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS43022H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:00:59.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411015833</udiDi>
    <basicUdiDi>B-10704411015833</basicUdiDi>
    <tradeName>AMSure® Hydrophilic Latex Foley Catheter</tradeName>
    <deviceName>Hydrophilic Foley 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020201</emdnCode>
    <emdnDescription>URETERAL CATHETERS FOR OCCLUSION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS43020H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:00:55.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411015826</udiDi>
    <basicUdiDi>B-10704411015826</basicUdiDi>
    <tradeName>AMSure® Hydrophilic Latex Foley Catheter</tradeName>
    <deviceName>Hydrophilic Foley 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020201</emdnCode>
    <emdnDescription>URETERAL CATHETERS FOR OCCLUSION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS43018H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:00:54.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411015819</udiDi>
    <basicUdiDi>B-10704411015819</basicUdiDi>
    <tradeName>AMSure® Hydrophilic Latex Foley Catheter</tradeName>
    <deviceName>Hydrophilic Foley 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020201</emdnCode>
    <emdnDescription>URETERAL CATHETERS FOR OCCLUSION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS43016H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:00:53.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411014690</udiDi>
    <basicUdiDi>B-10704411014690</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>AS89818S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:00:53.009Z</lastUpdated>
  </row>
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