<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-NB-31541UW</udiDi>
    <basicUdiDi>B-NB-31541UW</basicUdiDi>
    <tradeName>D-NB-31541UW</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-31541</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:19:33.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NB-31521UQ</udiDi>
    <basicUdiDi>B-NB-31521UQ</basicUdiDi>
    <tradeName>D-NB-31521UQ</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-31521</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:19:32.424Z</lastUpdated>
  </row>
  <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>D-8901117HPK0123KYQM</udiDi>
    <basicUdiDi>B-8901117HPK0123KYQM</basicUdiDi>
    <tradeName>Huf Puf Kit</tradeName>
    <deviceName>Huf Puf Kit (spacer + mask)</deviceName>
    <manufacturerName>Cipla Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000038939</manufacturerSrn>
    <authorisedRepresentativeName>Cipla Europe NV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000038918</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010399</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Not Applicable for Huf Puf Kit</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:30:17.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698973762494</udiDi>
    <basicUdiDi>B-08698973762494</basicUdiDi>
    <tradeName>Nimo Mesh Nebulizer Mask Set</tradeName>
    <deviceName>Mesh Nebulizer Mask Set</deviceName>
    <manufacturerName>Hünkar Ecza ve Medikal San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000034965</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNK-MESH-01-02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:11:25.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698973762470</udiDi>
    <basicUdiDi>B-08698973762470</basicUdiDi>
    <tradeName>Sanity Nebulizer Set – Mouthpiece</tradeName>
    <deviceName>Nebulizer Set – Mouthpiece</deviceName>
    <manufacturerName>Hünkar Ecza ve Medikal San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000034965</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>099-112</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:11:24.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698973762128</udiDi>
    <basicUdiDi>B-08698973762128</basicUdiDi>
    <tradeName>Nimo Mesh Nebulizer Pediatric Mask</tradeName>
    <deviceName>Mesh Nebulizer Pediatric Mask</deviceName>
    <manufacturerName>Hünkar Ecza ve Medikal San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000034965</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNK-MESH-01-03</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:11:22.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698973762111</udiDi>
    <basicUdiDi>B-08698973762111</basicUdiDi>
    <tradeName>Nimo Mesh Nebulizer Adult Mask</tradeName>
    <deviceName>Mesh Nebulizer Adult Mask</deviceName>
    <manufacturerName>Hünkar Ecza ve Medikal San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000034965</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNK-MESH-01-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:11:20.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698973761640</udiDi>
    <basicUdiDi>B-08698973761640</basicUdiDi>
    <tradeName>Nimo Nebulizer Set - Pediatric</tradeName>
    <deviceName>Nebulizer Set - Pediatric</deviceName>
    <manufacturerName>Hünkar Ecza ve Medikal San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000034965</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>099-142</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:11:18.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698973761633</udiDi>
    <basicUdiDi>B-08698973761633</basicUdiDi>
    <tradeName>Nimo Nebulizer Set - Adult</tradeName>
    <deviceName>Nebulizer Set - Adult</deviceName>
    <manufacturerName>Hünkar Ecza ve Medikal San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000034965</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>099-132</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:11:17.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698973761558</udiDi>
    <basicUdiDi>B-08698973761558</basicUdiDi>
    <tradeName>Nimo Nebulizer Set - Mouthpiece</tradeName>
    <deviceName>Nebulizer Set - Mouthpiece</deviceName>
    <manufacturerName>Hünkar Ecza ve Medikal San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000034965</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010380</emdnCode>
    <emdnDescription>AEROSOL THERAPY SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>099-112</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:11:16.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681227070681</udiDi>
    <basicUdiDi>B-08681227070681</basicUdiDi>
    <tradeName>ARTIMED</tradeName>
    <deviceName>NEBULİZER SET (HAZNELİ MASKE) (Pediatrik)</deviceName>
    <manufacturerName>CEREN ÜRETİM PLASTİK ÜRÜNLERİ SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022140</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P-2030 2009</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T10:11:36.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681227070674</udiDi>
    <basicUdiDi>B-08681227070674</basicUdiDi>
    <tradeName>ARTIMED</tradeName>
    <deviceName>NEBULİZER SET (HAZNELİ MASKE) (Yetişkin)</deviceName>
    <manufacturerName>CEREN ÜRETİM PLASTİK ÜRÜNLERİ SANAYİ TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022140</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-2030 2008</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T10:11:34.150Z</lastUpdated>
  </row>
</eudamedExport>