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<eudamedExport entity="devices">
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    <udiDi>04710810081910</udiDi>
    <basicUdiDi>471081008RNOMAP</basicUdiDi>
    <tradeName>Silicone 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>AM0017</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810081927</udiDi>
    <basicUdiDi>471081008NNDO8W</basicUdiDi>
    <tradeName>Softip-3 Nasal Cannula, 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>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0071</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810081934</udiDi>
    <basicUdiDi>471081008NND378</basicUdiDi>
    <tradeName>OM-3 HiO2 Mask, Child w/Tubing, PVC Bag</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>AO0097</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810081941</udiDi>
    <basicUdiDi>471081008NND378</basicUdiDi>
    <tradeName>OM-2 Oxygen 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>AO0139</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810081958</udiDi>
    <basicUdiDi>471081008NND378</basicUdiDi>
    <tradeName>OM-2 Oxygen 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>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0138</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810081965</udiDi>
    <basicUdiDi>471081008RNQTBB</basicUdiDi>
    <tradeName>Silicone Hose, 17T, 90cm w/Cuff 22Fx2</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>AT0013</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810081972</udiDi>
    <basicUdiDi>471081008RNQTBB</basicUdiDi>
    <tradeName>Silicone Hose, 17T, 150cm w/Cuff 22Fx2</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>AT0014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810081989</udiDi>
    <basicUdiDi>471081008RNQTBB</basicUdiDi>
    <tradeName>Silicone Hose, 17T, 180cm w/Cuff 22Fx2</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>AT0015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810081996</udiDi>
    <basicUdiDi>471081008RNQTBB</basicUdiDi>
    <tradeName>Silicone Hose, 17T, 120cm w/Cuff 22Fx2</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>AT0016</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082023</udiDi>
    <basicUdiDi>471081008RNQ197</basicUdiDi>
    <tradeName>Sil.Flex Hose, 22F, 110cm</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>AB0140</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082030</udiDi>
    <basicUdiDi>471081008NNTB9L</basicUdiDi>
    <tradeName>TC-2 Hose Clip, 22F w/5 clips</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 CIRCUITS SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082047</udiDi>
    <basicUdiDi>471081008RNQ197</basicUdiDi>
    <tradeName>Slim-Cuff Silicone Hose, 15F, 10F, 30cm</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>AT0040</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082054</udiDi>
    <basicUdiDi>471081008NND174</basicUdiDi>
    <tradeName>C22 Star Lumen Tubing, 1000cm</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>AO0065</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082085</udiDi>
    <basicUdiDi>471081008NNE47D</basicUdiDi>
    <tradeName>LVN Nebulizer, 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>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH0032</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082092</udiDi>
    <basicUdiDi>471081008NND276</basicUdiDi>
    <tradeName>OM-2 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>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082108</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>AO0084</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082115</udiDi>
    <basicUdiDi>471081008NND276</basicUdiDi>
    <tradeName>OM-2 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>AO0085</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082122</udiDi>
    <basicUdiDi>471081008NNE177</basicUdiDi>
    <tradeName>Neb.Easy AM-1 Mask, Child 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>AD0051</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082139</udiDi>
    <basicUdiDi>471081008NNDO8W</basicUdiDi>
    <tradeName>Softip-1 Nasal Cannula, 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>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0067</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082153</udiDi>
    <basicUdiDi>471081008RNQ197</basicUdiDi>
    <tradeName>Silicone Hose, 19T, 15cm, w/ L22F, 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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BREATHING CIRCUITS, W/O WATER TRAP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC0068</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.444Z</lastUpdated>
  </row>
</eudamedExport>