<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06973351317322</udiDi>
    <basicUdiDi>B-06973351317322</basicUdiDi>
    <tradeName>Nebulizer Mask</tradeName>
    <deviceName>Nebulizer Mask</deviceName>
    <manufacturerName>Ningbo Trustlab Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008493</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GT012-100</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:08:17.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973351317315</udiDi>
    <basicUdiDi>B-06973351317315</basicUdiDi>
    <tradeName>Nebulizer Mask</tradeName>
    <deviceName>Nebulizer Mask</deviceName>
    <manufacturerName>Ningbo Trustlab Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008493</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GT012-100</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:08:16.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934325307022</udiDi>
    <basicUdiDi>69343253R030132BYJ</basicUdiDi>
    <tradeName>06934325307022</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FEELLIFE HEALTH INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000000782</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L7</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:47:56.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904399170752</udiDi>
    <basicUdiDi>89043991HSRTD026N</basicUdiDi>
    <tradeName>Nebulizer Mask</tradeName>
    <deviceName>Nebulizer Mask</deviceName>
    <manufacturerName>Harsoria Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000018349</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7075</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:33:20.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902095201114</udiDi>
    <basicUdiDi>890209520111DK</basicUdiDi>
    <tradeName>Nebulizer Mask</tradeName>
    <deviceName>Nebulizer Mask</deviceName>
    <manufacturerName>Poly Medicure Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000043009</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20111</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:19:46.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698898250052</udiDi>
    <basicUdiDi>869889825SIP00577</basicUdiDi>
    <tradeName>Oxy2Mask Difüzör Maske Aerosol Pediatrik</tradeName>
    <deviceName>Oxy2Mask Difüzör Maske Aerosol Pediatrik</deviceName>
    <manufacturerName>Yiğit Sağlık Araç ve Gereçleri Paz. İth. İhr. Ltd. Şti</manufacturerName>
    <manufacturerSrn>TR-PR-000051597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIP005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:53:33.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>86988638306612</udiDi>
    <basicUdiDi>869886383T20176N8</basicUdiDi>
    <tradeName>86988638306612</tradeName>
    <deviceName>ATOMIZER CHAMBER</deviceName>
    <manufacturerName>TMS MEDİKAL PLASTİK ÜRÜNLERİ SANAYİ VE DIŞ TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000019237</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T20176</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:50:49.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056814720049</udiDi>
    <basicUdiDi>805681472MASCGK</basicUdiDi>
    <tradeName>MASCHERA IN PLT BIANCA</tradeName>
    <deviceName>MASCHERA PER AEROSOL</deviceName>
    <manufacturerName>F.LLI MARCHESI SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000040181</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL00206SF00</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:21:48.435Z</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>R03010301</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>04710810084263</udiDi>
    <basicUdiDi>471081008NNE37B</basicUdiDi>
    <tradeName>AM-2 Aerosol 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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0069</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:22.631Z</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>R03010301</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>R03010301</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>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>R03010301</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>04710810085086</udiDi>
    <basicUdiDi>471081008NNE37B</basicUdiDi>
    <tradeName>AM-3 Aerosol 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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0067</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:21.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810085949</udiDi>
    <basicUdiDi>471081008NNE177</basicUdiDi>
    <tradeName>Neb.Easy AM-2 Mask, Adult 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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0054</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:21.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810088285</udiDi>
    <basicUdiDi>471081008NNE177</basicUdiDi>
    <tradeName>Neb.Easy AM-2 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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0058</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:19.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810089480</udiDi>
    <basicUdiDi>471081008NNE177</basicUdiDi>
    <tradeName>Neb.Easy AM-2 Mask, Adult 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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0061</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:18.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810089718</udiDi>
    <basicUdiDi>471081008NNE37B</basicUdiDi>
    <tradeName>AM-1 Aerosol Mask, Infant</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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0064</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:18.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810106729</udiDi>
    <basicUdiDi>471081008NNE177</basicUdiDi>
    <tradeName>Neb.Easy AM-2 Mask, Adult 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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:55.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810106736</udiDi>
    <basicUdiDi>471081008NNE177</basicUdiDi>
    <tradeName>Neb.Easy AM-2 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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:55.876Z</lastUpdated>
  </row>
</eudamedExport>