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<eudamedExport entity="devices">
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    <udiDi>10704411016533</udiDi>
    <basicUdiDi>B-10704411016533</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>IVE2000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:25.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411016526</udiDi>
    <basicUdiDi>B-10704411016526</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>IVE1501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:01:25.030Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <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>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>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>10704411014638</udiDi>
    <basicUdiDi>B-10704411014638</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>AE3300</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:00:40.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411013921</udiDi>
    <basicUdiDi>B-10704411013921</basicUdiDi>
    <tradeName>10704411013921</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>IVE11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:59:55.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411013914</udiDi>
    <basicUdiDi>B-10704411013914</basicUdiDi>
    <tradeName>10704411013914</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>IVE10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:59:51.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411013730</udiDi>
    <basicUdiDi>B-10704411013730</basicUdiDi>
    <tradeName>AMSINO 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>AP2089E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:59:50.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411013723</udiDi>
    <basicUdiDi>B-10704411013723</basicUdiDi>
    <tradeName>AMSINO 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>AP2086E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:59:49.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411013341</udiDi>
    <basicUdiDi>B-10704411013341</basicUdiDi>
    <tradeName>AMSINO High Pressure Sets</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>HPE0215</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:59:48.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411013334</udiDi>
    <basicUdiDi>B-10704411013334</basicUdiDi>
    <tradeName>AMSINO High Pressure Sets</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>HPE0205</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:59:44.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411013310</udiDi>
    <basicUdiDi>B-10704411013310</basicUdiDi>
    <tradeName>AMSINO High Pressure Sets</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>HPE0210</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:59:44.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411013303</udiDi>
    <basicUdiDi>B-10704411013303</basicUdiDi>
    <tradeName>AMSINO High Pressure Sets</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>HPE0200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:59:43.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411012221</udiDi>
    <basicUdiDi>B-10704411012221</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>IVE2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:56:40.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411012214</udiDi>
    <basicUdiDi>B-10704411012214</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>IVE1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:56:38.902Z</lastUpdated>
  </row>
</eudamedExport>