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    <basicUdiDi>471081008RNOMAP</basicUdiDi>
    <tradeName>Sil.Flex Mask, #1</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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:55.300Z</lastUpdated>
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  <row>
    <udiDi>04710810080753</udiDi>
    <basicUdiDi>471081008RNOMAP</basicUdiDi>
    <tradeName>Rendell Baker Silicone Mask, #2</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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:54.875Z</lastUpdated>
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  <row>
    <udiDi>04710810080760</udiDi>
    <basicUdiDi>471081008RNOMAP</basicUdiDi>
    <tradeName>Rendell Baker 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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0022</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:54.851Z</lastUpdated>
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  <row>
    <udiDi>04710810080906</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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:54.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810080982</udiDi>
    <basicUdiDi>471081008RNOMAP</basicUdiDi>
    <tradeName>Silicone Mask, #5</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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:54.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810081750</udiDi>
    <basicUdiDi>471081008RNOMAP</basicUdiDi>
    <tradeName>Rendell Baker Silicone Mask, #0</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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0019</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:54.151Z</lastUpdated>
  </row>
  <row>
    <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>R03010201</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>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>R03010201</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>R03010201</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>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>R03010201</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>R03010201</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>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>R03010201</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>04710810082283</udiDi>
    <basicUdiDi>471081008NND378</basicUdiDi>
    <tradeName>OM-2 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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0094</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082320</udiDi>
    <basicUdiDi>471081008NND378</basicUdiDi>
    <tradeName>OM-2 HiO2 Mask, Adult 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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0093</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:53.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082764</udiDi>
    <basicUdiDi>471081008NNDO8W</basicUdiDi>
    <tradeName>Softip-1 Nasal Cannula, 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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0068</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:52.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082795</udiDi>
    <basicUdiDi>471081008NND276</basicUdiDi>
    <tradeName>OM-2 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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0133</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:52.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810083198</udiDi>
    <basicUdiDi>471081008RNOMAP</basicUdiDi>
    <tradeName>Sil.Flex-2 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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0023</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:23.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810083204</udiDi>
    <basicUdiDi>471081008RNOMAP</basicUdiDi>
    <tradeName>Sil.Flex-2 Mask, #5</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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0086</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:23.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810083372</udiDi>
    <basicUdiDi>471081008NND378</basicUdiDi>
    <tradeName>OM-3 HiO2 Mask, Adult 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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0095</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:23.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810083389</udiDi>
    <basicUdiDi>471081008NND276</basicUdiDi>
    <tradeName>OM-3 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>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0154</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:23.537Z</lastUpdated>
  </row>
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