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<eudamedExport entity="devices">
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    <udiDi>04710810084126</udiDi>
    <basicUdiDi>471081008NNH57Q</basicUdiDi>
    <tradeName>CV-3 Manifold w/6B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084133</udiDi>
    <basicUdiDi>471081008RNOMAP</basicUdiDi>
    <tradeName>Sil.Flex-2 Mask, #4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0024</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084225</udiDi>
    <basicUdiDi>471081008RNQ299</basicUdiDi>
    <tradeName>Hytrel Hose, 10F/10T, 60cm, Ivory</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT0007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.649Z</lastUpdated>
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  <row>
    <udiDi>04710810084263</udiDi>
    <basicUdiDi>471081008NNE37B</basicUdiDi>
    <tradeName>AM-2 Aerosol Mask, Adult</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0069</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084294</udiDi>
    <basicUdiDi>471081008NNbLB3</basicUdiDi>
    <tradeName>Mouth Piece 22F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RESPIRATORY MOUTHPIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0029</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084317</udiDi>
    <basicUdiDi>471081008NNP48E</basicUdiDi>
    <tradeName>SY Connector, 22/15mm, 22M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC0029</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084324</udiDi>
    <basicUdiDi>471081008NNH57Q</basicUdiDi>
    <tradeName>CV-3 Manifold</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084454</udiDi>
    <basicUdiDi>471081008NNH27J</basicUdiDi>
    <tradeName>Water Trap, 22M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, WITH WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0275</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084478</udiDi>
    <basicUdiDi>471081008RNH28E</basicUdiDi>
    <tradeName>Water Trap, 22M, Amber</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, WITH WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0113</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084508</udiDi>
    <basicUdiDi>471081008NNP88N</basicUdiDi>
    <tradeName>LV-2 Valve, 19M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0025</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084515</udiDi>
    <basicUdiDi>471081008RNP59C</basicUdiDi>
    <tradeName>L Connector, 22F, 22/15mm, PSF</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC0021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084553</udiDi>
    <basicUdiDi>471081008NNP28A</basicUdiDi>
    <tradeName>T Connector , 22M, 22/15mm, 22M, 7.6F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC0170</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084577</udiDi>
    <basicUdiDi>471081008RNP69E</basicUdiDi>
    <tradeName>DS-L Connector w/Suction Port, 15F, 15M, PSF</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC0117</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084584</udiDi>
    <basicUdiDi>471081008NNP48E</basicUdiDi>
    <tradeName>SY Connector, Luer, 22/15mm, 22M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC0010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084638</udiDi>
    <basicUdiDi>471081008NND97L</basicUdiDi>
    <tradeName>Swivel Connector for Oxygen Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0046</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084645</udiDi>
    <basicUdiDi>471081008NND57C</basicUdiDi>
    <tradeName>OM-4 Trachea Mask, Adult w/Tubing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0105</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084652</udiDi>
    <basicUdiDi>471081008NND57C</basicUdiDi>
    <tradeName>OM-4 Trachea Mask, Child w/Tubing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0104</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084669</udiDi>
    <basicUdiDi>471081008NNH47N</basicUdiDi>
    <tradeName>Adj. PEEP Valve, 5~20cmH2O</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STANDARD BREATHING CIRCUITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV0002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084676</udiDi>
    <basicUdiDi>471081008NND378</basicUdiDi>
    <tradeName>OM-2 HiO2 Mask, Child w/Tubing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0092</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084690</udiDi>
    <basicUdiDi>471081008NNI37P</basicUdiDi>
    <tradeName>Breathing Bag, 3L, Latex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0106</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.280Z</lastUpdated>
  </row>
</eudamedExport>