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<eudamedExport entity="devices">
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    <udiDi>10704411021889</udiDi>
    <basicUdiDi>B-10704411021889</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>IV4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:52.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021872</udiDi>
    <basicUdiDi>B-10704411021872</basicUdiDi>
    <tradeName>AMSure® Enteral Administration Kit</tradeName>
    <deviceName>Enteral Feeding 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>A03010301</emdnCode>
    <emdnDescription>ENTERAL FEEDING GRAVITY CONTROLLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENG1200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:51.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021865</udiDi>
    <basicUdiDi>B-10704411021865</basicUdiDi>
    <tradeName>AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ Tip and transition connector</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>ENS015T</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:51.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021858</udiDi>
    <basicUdiDi>B-10704411021858</basicUdiDi>
    <tradeName>AMSure® HG Hydrophilic Intermittent Catheter</tradeName>
    <deviceName>Hydrophilic Intermittent 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>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HG970616</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:50.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021827</udiDi>
    <basicUdiDi>B-10704411021827</basicUdiDi>
    <tradeName>AMSure® HG Hydrophilic Intermittent Catheter</tradeName>
    <deviceName>Hydrophilic Intermittent 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>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HG970610</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:46.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021643</udiDi>
    <basicUdiDi>B-10704411021643</basicUdiDi>
    <tradeName>AMSure® Collection 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>G-28149</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:45.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021841</udiDi>
    <basicUdiDi>B-10704411021841</basicUdiDi>
    <tradeName>AMSure® HG Hydrophilic Intermittent Catheter</tradeName>
    <deviceName>Hydrophilic Intermittent 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>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HG970614</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:44.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021834</udiDi>
    <basicUdiDi>B-10704411021834</basicUdiDi>
    <tradeName>AMSure® HG Hydrophilic Intermittent Catheter</tradeName>
    <deviceName>Hydrophilic Intermittent 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>U01010501</emdnCode>
    <emdnDescription>NELATON CATHETERS, SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HG970612</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:44.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021629</udiDi>
    <basicUdiDi>B-10704411021629</basicUdiDi>
    <tradeName>AMSure® Mucus Trap</tradeName>
    <deviceName>Mucus Trap</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>W05019003</emdnCode>
    <emdnDescription>SPUTUM COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS79800</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:26.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021612</udiDi>
    <basicUdiDi>B-10704411021612</basicUdiDi>
    <tradeName>AMSure® Mucus Trap</tradeName>
    <deviceName>Mucus Trap</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>W05019003</emdnCode>
    <emdnDescription>SPUTUM COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS79400</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:26.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021414</udiDi>
    <basicUdiDi>B-10704411021414</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>AS327500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:25.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021056</udiDi>
    <basicUdiDi>B-10704411021056</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>UB2000TV</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:24.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021049</udiDi>
    <basicUdiDi>B-10704411021049</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>UB2000TT</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:20.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411021032</udiDi>
    <basicUdiDi>B-10704411021032</basicUdiDi>
    <tradeName>AMSure® Economy Urinary 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>UB2000FV-P</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:19.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411020097</udiDi>
    <basicUdiDi>B-10704411020097</basicUdiDi>
    <tradeName>10704411020097</tradeName>
    <deviceName>Blood Transfusion Set with needle</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>TF-4D2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:18.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411020080</udiDi>
    <basicUdiDi>B-10704411020080</basicUdiDi>
    <tradeName>10704411020080</tradeName>
    <deviceName>Blood Transfusion Set with needle</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>IS2101TH-G_NST</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:18.160Z</lastUpdated>
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  <row>
    <udiDi>10704411020073</udiDi>
    <basicUdiDi>B-10704411020073</basicUdiDi>
    <tradeName>10704411020073</tradeName>
    <deviceName>Blood Transfusion Set with needle</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>ET-TF0113-A1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:14.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411019992</udiDi>
    <basicUdiDi>B-10704411019992</basicUdiDi>
    <tradeName>AMSafe® Blood transfusion set with needle</tradeName>
    <deviceName>Blood Transfusion Set with needle</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>AS2101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:13.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411019985</udiDi>
    <basicUdiDi>B-10704411019985</basicUdiDi>
    <tradeName>AMSINO Blood Administration 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>AS2100SI</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:12.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411019879</udiDi>
    <basicUdiDi>B-10704411019879</basicUdiDi>
    <tradeName>AMSure® Stomach Tube</tradeName>
    <deviceName>Sterile-Stomach 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G02020101</emdnCode>
    <emdnDescription>NASOGASTRIC TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS81018</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:04:11.741Z</lastUpdated>
  </row>
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