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<eudamedExport entity="devices">
  <row>
    <udiDi>06923980110832</udiDi>
    <basicUdiDi>69239801FD2AFKY</basicUdiDi>
    <tradeName>Neb.Easy Nebulizer kit, 22F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</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>AD0040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110849</udiDi>
    <basicUdiDi>69239801ND2MAPJ</basicUdiDi>
    <tradeName>Paediatric oxygen mask medium conc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRACHEOSTOMY O2 SUPPLIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XTA0022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110856</udiDi>
    <basicUdiDi>69239801ND2MAPJ</basicUdiDi>
    <tradeName>ADULT NASAL CANNULA W/O TUBING</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XTA0019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110863</udiDi>
    <basicUdiDi>69239801ND2MEPS</basicUdiDi>
    <tradeName>OM-4 Trachea Mask, Adult w/Tubing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRACHEOSTOMY O2 SUPPLIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0157</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110870</udiDi>
    <basicUdiDi>69239801ND2MFPU</basicUdiDi>
    <tradeName>OM-2 HiO2 Mask, Child w/Tubing, PVC Bag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0156</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110887</udiDi>
    <basicUdiDi>69239801ND2MFPU</basicUdiDi>
    <tradeName>OM-2 HiO2 Mask, Adult w/Tubing, PVC Bag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0155</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110894</udiDi>
    <basicUdiDi>69239801ND2MAPJ</basicUdiDi>
    <tradeName>OM-3 Mask, Adult w/Tubing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</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>AO0154</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110900</udiDi>
    <basicUdiDi>69239801ND2MAPJ</basicUdiDi>
    <tradeName>OM-3 Mask, Child w/Tubing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</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>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110917</udiDi>
    <basicUdiDi>69239801ND2MFPU</basicUdiDi>
    <tradeName>OM-2 Mask, Adult w/Tubing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0152</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110924</udiDi>
    <basicUdiDi>69239801ND2MFPU</basicUdiDi>
    <tradeName>OM-2 Mask, Child w/Tubing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0151</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110931</udiDi>
    <basicUdiDi>69239801ND2MAPJ</basicUdiDi>
    <tradeName>Softip-1 Nasal Cannula, Adult</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110948</udiDi>
    <basicUdiDi>69239801ND2MAPJ</basicUdiDi>
    <tradeName>Softip-1 Nasal Cannula, Child</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0149</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110955</udiDi>
    <basicUdiDi>69239801ND2MAPJ</basicUdiDi>
    <tradeName>Softip-3 Nasal Cannula, Infant</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0070</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110962</udiDi>
    <basicUdiDi>69239801ND2MFPU</basicUdiDi>
    <tradeName>OM-1 HiO2 Mask, Child w/Tubing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0088</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110979</udiDi>
    <basicUdiDi>69239801ND2MFPU</basicUdiDi>
    <tradeName>OM-1 HiO2 Mask, Adult w/Tubing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MASKS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0089</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110986</udiDi>
    <basicUdiDi>69239801ND2MGPW</basicUdiDi>
    <tradeName>LAV Venturi Mask Kit, Adult</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</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>AO0045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110993</udiDi>
    <basicUdiDi>69239801ND2MGPW</basicUdiDi>
    <tradeName>LAV Venturi Mask Kit, child</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</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>AO0162</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980111006</udiDi>
    <basicUdiDi>69239801ND2MGPW</basicUdiDi>
    <tradeName>LAV Venturi Mask Kit, infant</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</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>AO0163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980111013</udiDi>
    <basicUdiDi>69239801FD2AFKY</basicUdiDi>
    <tradeName>NEBULISER MOUTHPIECE KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</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>XTA0092</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980111037</udiDi>
    <basicUdiDi>69239801FD2ADKU</basicUdiDi>
    <tradeName>Adult aerosol mask - with tubing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</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>XTA0090</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.074Z</lastUpdated>
  </row>
</eudamedExport>