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<eudamedExport entity="devices">
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    <udiDi>04710810084720</udiDi>
    <basicUdiDi>471081008NND276</basicUdiDi>
    <tradeName>OM-1 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>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0128</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084737</udiDi>
    <basicUdiDi>471081008NND276</basicUdiDi>
    <tradeName>OM-3 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>AO0153</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084744</udiDi>
    <basicUdiDi>471081008NNE177</basicUdiDi>
    <tradeName>Neb-1 Nebulizer Mask, Child</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>AD0070</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084751</udiDi>
    <basicUdiDi>471081008NNE177</basicUdiDi>
    <tradeName>Neb-1 Nebulizer 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>AD0071</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084775</udiDi>
    <basicUdiDi>471081008NNI37P</basicUdiDi>
    <tradeName>Breathing Bag, 1L, 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>AB0104</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084812</udiDi>
    <basicUdiDi>471081008NNL37Y</basicUdiDi>
    <tradeName>MR-100 Reservoir Bag, 2500ml</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>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR0019</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084829</udiDi>
    <basicUdiDi>471081008NND276</basicUdiDi>
    <tradeName>OM-2 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>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0086</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084836</udiDi>
    <basicUdiDi>471081008NNP98Q</basicUdiDi>
    <tradeName>Connector, 22/15mm, 6M, PP</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>AC0139</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084843</udiDi>
    <basicUdiDi>471081008NNP28A</basicUdiDi>
    <tradeName>T Connector w/Luer, 22M, 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>AC0168</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084850</udiDi>
    <basicUdiDi>471081008NNP28A</basicUdiDi>
    <tradeName>T Connector, 22F, 22/18mm, 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>AC0171</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084874</udiDi>
    <basicUdiDi>471081008NNI37P</basicUdiDi>
    <tradeName>Breathing Bag, 0.5L, 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>AB0103</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084881</udiDi>
    <basicUdiDi>471081008RNI38K</basicUdiDi>
    <tradeName>Silicone Breathing Bag, 0.5L w/Loop End</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>AB0107</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:21.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084911</udiDi>
    <basicUdiDi>471081008RNP398</basicUdiDi>
    <tradeName>Y 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>AC0027</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:21.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084928</udiDi>
    <basicUdiDi>471081008NNI47R</basicUdiDi>
    <tradeName>EVA Catheter mount, 15cm w/Luer, 15M</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>AB0200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:21.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084942</udiDi>
    <basicUdiDi>471081008RNAM9D</basicUdiDi>
    <tradeName>Headgear for Nasal Mask, L</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 MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0042</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:21.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084966</udiDi>
    <basicUdiDi>471081008NNP38C</basicUdiDi>
    <tradeName>Y 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>AC0028</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:21.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084973</udiDi>
    <basicUdiDi>471081008RNLVAY</basicUdiDi>
    <tradeName>MR-100 Valve Kit, 5pcs</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>MANUALLY OPERATED PULMONARY RESUSCITATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR0004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:21.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084980</udiDi>
    <basicUdiDi>471081008NNE177</basicUdiDi>
    <tradeName>Neb.Easy AM-1 Mask, Infant w/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>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0053</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:21.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810084997</udiDi>
    <basicUdiDi>471081008RNOMAP</basicUdiDi>
    <tradeName>Silicone Mask, #3</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>AM0085</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:21.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810085062</udiDi>
    <basicUdiDi>471081008NNED8B</basicUdiDi>
    <tradeName>Neb.Easy Nebulizer Kit</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 KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0044</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:21.833Z</lastUpdated>
  </row>
</eudamedExport>