<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10704411021964</udiDi>
    <basicUdiDi>B-10704411021964</basicUdiDi>
    <tradeName>AMSINO Pediatric Solution Admin Set</tradeName>
    <deviceName></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>608101R-A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:28:57.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411020561</udiDi>
    <basicUdiDi>B-10704411020561</basicUdiDi>
    <tradeName>AMSureⓇ Closed Suction System</tradeName>
    <deviceName></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>R010399</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS363RC124H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:28:52.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021957</udiDi>
    <basicUdiDi>B-10704411021957</basicUdiDi>
    <tradeName>AMSINO Adult Solution Admin Set</tradeName>
    <deviceName></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>208801R-A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:28:34.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021940</udiDi>
    <basicUdiDi>B-10704411021940</basicUdiDi>
    <tradeName>AMSINO Adult Solution Admin Set</tradeName>
    <deviceName></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>208501R-A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:28:18.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411017691</udiDi>
    <basicUdiDi>B-10704411017691</basicUdiDi>
    <tradeName>AMSureⓇ Closed Suction System</tradeName>
    <deviceName></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>R010399</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS366TTP172</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:28:12.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021926</udiDi>
    <basicUdiDi>B-10704411021926</basicUdiDi>
    <tradeName>AMSINO Needleless Adult Solution Admin Set</tradeName>
    <deviceName></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>207701-A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:28:01.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021971</udiDi>
    <basicUdiDi>B-10704411021971</basicUdiDi>
    <tradeName>AMSINO Needleless Pediatric Solution Admin Set</tradeName>
    <deviceName></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>608102-A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:27:37.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411017684</udiDi>
    <basicUdiDi>B-10704411017684</basicUdiDi>
    <tradeName>AMSureⓇ Closed Suction System</tradeName>
    <deviceName></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>R010399</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS365TTP172</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:27:35.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021933</udiDi>
    <basicUdiDi>B-10704411021933</basicUdiDi>
    <tradeName>AMSINO Needleless Adult Solution Admin Set</tradeName>
    <deviceName></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>208101-A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:27:24.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411017677</udiDi>
    <basicUdiDi>B-10704411017677</basicUdiDi>
    <tradeName>AMSureⓇ Closed Suction System</tradeName>
    <deviceName></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>R010399</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS364TTP172</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:27:19.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021919</udiDi>
    <basicUdiDi>B-10704411021919</basicUdiDi>
    <tradeName>AMSINO Adult Vented Secondary Medication Solution Set</tradeName>
    <deviceName></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>203002-A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:27:08.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411017660</udiDi>
    <basicUdiDi>B-10704411017660</basicUdiDi>
    <tradeName>AMSureⓇ Closed Suction System</tradeName>
    <deviceName></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>R010399</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS363TTP172</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:27:06.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021902</udiDi>
    <basicUdiDi>B-10704411021902</basicUdiDi>
    <tradeName>AMSINO Adult Non-Vented Secondary Medication Solution Set</tradeName>
    <deviceName></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>203001-A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:26:44.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411017653</udiDi>
    <basicUdiDi>B-10704411017653</basicUdiDi>
    <tradeName>AMSureⓇ Closed Suction System</tradeName>
    <deviceName></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>R010399</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS366TP172</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:26:41.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411017646</udiDi>
    <basicUdiDi>B-10704411017646</basicUdiDi>
    <tradeName>AMSureⓇ Closed Suction System</tradeName>
    <deviceName></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>R010399</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS365TP172</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:26:26.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411017639</udiDi>
    <basicUdiDi>B-10704411017639</basicUdiDi>
    <tradeName>AMSureⓇ Closed Suction System</tradeName>
    <deviceName></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>R010399</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS364TP172</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:26:15.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411016311</udiDi>
    <basicUdiDi>B-10704411016311</basicUdiDi>
    <tradeName>AMSafe® Extension Set</tradeName>
    <deviceName></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>AE3601LL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:26:04.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411017622</udiDi>
    <basicUdiDi>B-10704411017622</basicUdiDi>
    <tradeName>AMSureⓇ Closed Suction System</tradeName>
    <deviceName></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>R010399</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS363TP172</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:25:54.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411014836</udiDi>
    <basicUdiDi>B-10704411014836</basicUdiDi>
    <tradeName>AMSureⓇ Closed Suction System</tradeName>
    <deviceName></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>R010399</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS366TC172</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:25:37.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411013679</udiDi>
    <basicUdiDi>B-10704411013679</basicUdiDi>
    <tradeName>I.V. Administration Set</tradeName>
    <deviceName></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>N-IS-01-A-ECEID</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-16T22:25:35.184Z</lastUpdated>
  </row>
</eudamedExport>