<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-NB-31511UM</udiDi>
    <basicUdiDi>B-NB-31511UM</basicUdiDi>
    <tradeName>D-NB-31511UM</tradeName>
    <deviceName>Nebulizer Kit, Mask, 7FT Oxygen Tube, Adult</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-31511</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:19:30.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-31142UC</udiDi>
    <basicUdiDi>B-NB-31142UC</basicUdiDi>
    <tradeName>D-NB-31142UC</tradeName>
    <deviceName>Nebulizer Kit, T-piece, Mouth Piece, Corrugate Tube, 7FT Oxygen Tube, Universal connector</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-31142</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:19:28.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-31141UA</udiDi>
    <basicUdiDi>B-NB-31141UA</basicUdiDi>
    <tradeName>D-NB-31141UA</tradeName>
    <deviceName>Nebulizer Kit, T-piece, Mouth Piece, Corrugate Tube, 7FT Oxygen Tube</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-31141</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:19:26.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-31122U6</udiDi>
    <basicUdiDi>B-NB-31122U6</basicUdiDi>
    <tradeName>D-NB-31122U6</tradeName>
    <deviceName>Nebulizer Kit, Mask, 7FT Oxygen Tube, Child Universal connector</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-31122</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:19:26.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-31121U4</udiDi>
    <basicUdiDi>B-NB-31121U4</basicUdiDi>
    <tradeName>D-NB-31121U4</tradeName>
    <deviceName>Nebulizer Kit, Mask, 7FT Oxygen Tube, Child</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-31121</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:19:24.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-31112U3</udiDi>
    <basicUdiDi>B-NB-31112U3</basicUdiDi>
    <tradeName>D-NB-31112U3</tradeName>
    <deviceName>Nebulizer Kit, Mask, 7FT Oxygen Tube, Adult Universal connector</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-31112</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:19:21.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-31111TZ</udiDi>
    <basicUdiDi>B-NB-31111TZ</basicUdiDi>
    <tradeName>D-NB-31111TZ</tradeName>
    <deviceName>Nebulizer Kit, Mask, 7FT Oxygen Tube, Adult</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-31111</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:19:20.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-30711UQ</udiDi>
    <basicUdiDi>B-NB-30711UQ</basicUdiDi>
    <tradeName>Aerosol Therapy system</tradeName>
    <deviceName>JET NEBULIZER MASK,ADULT SET 20CC 7Ft OXYGEN TUBING</deviceName>
    <manufacturerName>Besmed Health Business Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000007246</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB-31711</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:19:19.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>08907265011142</udiDi>
    <basicUdiDi>8907265B019YV</basicUdiDi>
    <tradeName>AERO MIST</tradeName>
    <deviceName>NEBULIZER: Mask / Mouth Piece with Nebulization Chamber and Tubing.</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH-2074S KAD</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:35.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699931750027</udiDi>
    <basicUdiDi>869993175NBL001U6</basicUdiDi>
    <tradeName>Nebulizer Set - Adult</tradeName>
    <deviceName>Nebulizer Set - Adult</deviceName>
    <manufacturerName>GENJECT SAGLIK URUNLERI VE KIMYA SAN. VE TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000024441</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NBL001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:15:05.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699931750010</udiDi>
    <basicUdiDi>869993175NBL002U8</basicUdiDi>
    <tradeName>Nebulizer Set - Child</tradeName>
    <deviceName>Nebulizer Set - Child</deviceName>
    <manufacturerName>GENJECT SAGLIK URUNLERI VE KIMYA SAN. VE TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000024441</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NBL002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:15:01.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810086243</udiDi>
    <basicUdiDi>471081008NNE47D</basicUdiDi>
    <tradeName>LVN Nebulizer, K Resin</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH0031</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:21.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810088964</udiDi>
    <basicUdiDi>471081008NNE279</basicUdiDi>
    <tradeName>Neb.Easy Bottle, 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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0096</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:55:18.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810106743</udiDi>
    <basicUdiDi>471081008NNE47D</basicUdiDi>
    <tradeName>LVN Nebulizer Kit</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0099</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:55.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810111716</udiDi>
    <basicUdiDi>471081008NNE57F</basicUdiDi>
    <tradeName>Isolated Nebulizer Kit, C3 Connector</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0036</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:54.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810117541</udiDi>
    <basicUdiDi>471081008NNE279</basicUdiDi>
    <tradeName>LF2 Nebulizer</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0017</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:51.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973912940433</udiDi>
    <basicUdiDi>697391294701RBAF</basicUdiDi>
    <tradeName>Portable Mesh Nebulizer kit</tradeName>
    <deviceName>Portable Mesh Nebulizer kit</deviceName>
    <manufacturerName>Shenzhen IMDK Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024290</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YM-3RB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:16:05.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816646331</udiDi>
    <basicUdiDi>69449327FR01E04KP</basicUdiDi>
    <tradeName>Welllead Mesh Nebulizer Kit</tradeName>
    <deviceName>Mesh Nebulizer Kit</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01L021010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:15.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816646157</udiDi>
    <basicUdiDi>69449327FR01E00KF</basicUdiDi>
    <tradeName>Welllead Mesh Nebulizer Kit</tradeName>
    <deviceName>Mesh Nebulizer Kit</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01L011010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:14.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015672114166</udiDi>
    <basicUdiDi>40156721141658</basicUdiDi>
    <tradeName>04015672114166</tradeName>
    <deviceName>NEB-ASKIT-16 (NEB-ASKIT-16E)</deviceName>
    <manufacturerName>OMRON Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000007213</manufacturerSrn>
    <authorisedRepresentativeName>OMRON Healthcare Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002683</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NEB-ASKIT-16E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:48:35.308Z</lastUpdated>
  </row>
</eudamedExport>