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<eudamedExport entity="devices">
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    <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>10704411005223</udiDi>
    <basicUdiDi>B-10704411005223</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>MR3108</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:03.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411005209</udiDi>
    <basicUdiDi>B-10704411005209</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>MR0106</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:03.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411005070</udiDi>
    <basicUdiDi>B-10704411005070</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>MR0606</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:52:01.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411004301</udiDi>
    <basicUdiDi>B-10704411004301</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>IVE3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:51:59.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411005032</udiDi>
    <basicUdiDi>B-10704411005032</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>MR4Y32</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:51:55.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411003014</udiDi>
    <basicUdiDi>B-10704411003014</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>AE3603</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:49:56.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411002956</udiDi>
    <basicUdiDi>B-10704411002956</basicUdiDi>
    <tradeName>AMSafe® Microbore 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>AE0106B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:49:55.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411002918</udiDi>
    <basicUdiDi>B-10704411002918</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>608306</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:49:54.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411002901</udiDi>
    <basicUdiDi>B-10704411002901</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>608305</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:49:50.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>10704411002895</udiDi>
    <basicUdiDi>B-10704411002895</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>607201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:49:50.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806368530126</udiDi>
    <basicUdiDi>B-08806368530126</basicUdiDi>
    <tradeName>08806368530126</tradeName>
    <deviceName>Accumate Reservoir Bag</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>PCA-PU250N</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T07:00:08.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806368530119</udiDi>
    <basicUdiDi>B-08806368530119</basicUdiDi>
    <tradeName>08806368530119</tradeName>
    <deviceName>Accumate Reservoir Bag</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>PCA-PU150N</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T07:00:07.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806368530102</udiDi>
    <basicUdiDi>B-08806368530102</basicUdiDi>
    <tradeName>08806368530102</tradeName>
    <deviceName>Accumate Reservoir Bag</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>PCA-PU500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T07:00:07.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806368530096</udiDi>
    <basicUdiDi>B-08806368530096</basicUdiDi>
    <tradeName>08806368530096</tradeName>
    <deviceName>Accumate Reservoir Bag</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>PCA-PU250</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T07:00:03.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806368530089</udiDi>
    <basicUdiDi>B-08806368530089</basicUdiDi>
    <tradeName>08806368530089</tradeName>
    <deviceName>Accumate Reservoir Bag</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>PCA-PU150</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T07:00:02.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806368530058</udiDi>
    <basicUdiDi>B-08806368530058</basicUdiDi>
    <tradeName>08806368530058</tradeName>
    <deviceName>Accumate Tubing Set</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>PCA-L1100E</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T07:00:02.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806368530041</udiDi>
    <basicUdiDi>B-08806368530041</basicUdiDi>
    <tradeName>08806368530041</tradeName>
    <deviceName>Accumate Tubing Set</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>PCA-L1150</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T07:00:01.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806368530034</udiDi>
    <basicUdiDi>B-08806368530034</basicUdiDi>
    <tradeName>08806368530034</tradeName>
    <deviceName>Accumate Tubing Set</deviceName>
    <manufacturerName>Woo Young Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022134</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>PCA-L1100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:59:56.648Z</lastUpdated>
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</eudamedExport>