<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06923980109317</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Air Cushion Mask</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XTA0108</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:50.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980109324</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Air Cushion Mask   MAYO NO:SMHC 2216</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XTA0109</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:50.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980109331</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Air-soft Mask size 2 w/valve 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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XTA0110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:50.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980109348</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Air-Soft Mask Size 3 w/valve Child Large</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XTA0111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:50.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980109355</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Air Cushion Mask w/valve-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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XTA0112</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:50.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980109362</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Air-Soft Mask Size 5 w/valve Adult Large</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XTA0113</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:50.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980109379</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Air-Soft Mask Size 6 w/valve</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XTA0122</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:50.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980111860</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Endo Mask, M w/Harness</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW0065</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:47.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980112270</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>PEP Aircushion Mask, M</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>R03010101</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0181</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:47.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980112553</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Aircushion mask, size 1, infant large</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XMR0021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:47.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980112560</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Aircushion mask, size 2, 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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XMR0023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:47.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980112577</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Aircushion mask, size 3, child large</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XMR0024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:47.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980112584</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Aircushion mask, Size 5, Adult Large</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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XMR0026</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:47.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980112591</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Aircushion mask, size 0, 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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XMR0101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:47.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980112607</udiDi>
    <basicUdiDi>69239801ND2KDPJ</basicUdiDi>
    <tradeName>Aircushion mask, size 4, 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>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XMR0102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:47.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675035619</udiDi>
    <basicUdiDi>040486751208010PK19L0102N</basicUdiDi>
    <tradeName>ComfortStar Maske Standard 3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01513</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T06:14:38.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675035626</udiDi>
    <basicUdiDi>040486751208010PK19L0102N</basicUdiDi>
    <tradeName>ComfortStar Maske Standard 4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01514</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T06:14:38.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675035633</udiDi>
    <basicUdiDi>040486751208010PK19L0102N</basicUdiDi>
    <tradeName>ComfortStar Maske Standard 5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01515</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T06:14:38.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675035640</udiDi>
    <basicUdiDi>040486751208010PK19L0102N</basicUdiDi>
    <tradeName>ComfortStar Maske Standard 6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01516</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T06:14:38.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675035657</udiDi>
    <basicUdiDi>040486751208010PK19L0102N</basicUdiDi>
    <tradeName>ComfortStar Maske Erdbeere 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01521</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T06:14:38.449Z</lastUpdated>
  </row>
</eudamedExport>