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<eudamedExport entity="devices">
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    <udiDi>04710810081934</udiDi>
    <basicUdiDi>471081008NND378</basicUdiDi>
    <tradeName>OM-3 HiO2 Mask, Child w/Tubing, PVC Bag</tradeName>
    <deviceName>Hi-Oxygen Mask</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>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0097</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:24:22.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810081927</udiDi>
    <basicUdiDi>471081008NNDO8W</basicUdiDi>
    <tradeName>Softip-3 Nasal Cannula, Child</tradeName>
    <deviceName>Nasal Cannula</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>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0071</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:24:18.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810080319</udiDi>
    <basicUdiDi>471081008RNOMAP</basicUdiDi>
    <tradeName>Sil.Flex Mask, #0</tradeName>
    <deviceName>Reusable Silicone Mask</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>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:23:19.360Z</lastUpdated>
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  <row>
    <udiDi>03666256013316</udiDi>
    <basicUdiDi>3666256D0100A00VENU0804TJ</basicUdiDi>
    <tradeName>Masque hyperventilation adulte</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Int'Air Médical</manufacturerName>
    <manufacturerSrn>FR-MF-000000328</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPP91</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:24:48.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>00874750005703</udiDi>
    <basicUdiDi>081713602691312BD</basicUdiDi>
    <tradeName>00874750005703</tradeName>
    <deviceName>Oro-Nasal Mask</deviceName>
    <manufacturerName>Hans Rudolph Inc</manufacturerName>
    <manufacturerSrn>US-MF-000004498</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>115001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:05:29.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>06940626002016</udiDi>
    <basicUdiDi>B-06940626002016</basicUdiDi>
    <tradeName>06940626002016</tradeName>
    <deviceName>Oxygen Mask with Reservoir Bag</deviceName>
    <manufacturerName>Hangzhou Superds Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030075</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0201</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-25T04:50:08.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>06940626001033</udiDi>
    <basicUdiDi>B-06940626001033</basicUdiDi>
    <tradeName>06940626001033</tradeName>
    <deviceName>Oxygen Mask</deviceName>
    <manufacturerName>Hangzhou Superds Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030075</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0103</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-25T04:50:07.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>06940626001026</udiDi>
    <basicUdiDi>B-06940626001026</basicUdiDi>
    <tradeName>06940626001026</tradeName>
    <deviceName>Oxygen Mask</deviceName>
    <manufacturerName>Hangzhou Superds Industry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030075</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0102</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-25T04:50:06.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975519160921</udiDi>
    <basicUdiDi>697551916OMNSTQ</basicUdiDi>
    <tradeName>16975519160921</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Adult-L-04(non sterile)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T08:47:18.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975519160938</udiDi>
    <basicUdiDi>697551916OMNSTQ</basicUdiDi>
    <tradeName>16975519160938</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Pediatric-S-06(non sterile)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T08:47:18.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975519160945</udiDi>
    <basicUdiDi>697551916OMNSTQ</basicUdiDi>
    <tradeName>16975519160945</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Hanbo Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027198</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Pediatric-L-08(non sterile)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T08:47:18.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>00890404552102</udiDi>
    <basicUdiDi>89040455210SC</basicUdiDi>
    <tradeName>00890404552102</tradeName>
    <deviceName>Oxygen Mask</deviceName>
    <manufacturerName>Vitromed Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000021420</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>5210</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:11:25.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>00890404552126</udiDi>
    <basicUdiDi>89040455210SC</basicUdiDi>
    <tradeName>00890404552126</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitromed Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000021420</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>5212</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:49:15.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>00890404552140</udiDi>
    <basicUdiDi>89040455210SC</basicUdiDi>
    <tradeName>00890404552140</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitromed Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000021420</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>5214</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:49:15.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>00890404552157</udiDi>
    <basicUdiDi>89040455210SC</basicUdiDi>
    <tradeName>00890404552157</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitromed Healthcare</manufacturerName>
    <manufacturerSrn>IN-MF-000021420</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>5215</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:49:15.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004251610</udiDi>
    <basicUdiDi>622300425OFM2004TL</basicUdiDi>
    <tradeName>ULTRAMED OXYGEN FACE MASK (Medium Concentration With Tube) (Paediatric Standard)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2004-02</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-20T13:57:21.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004253348</udiDi>
    <basicUdiDi>622300425OFM2004TL</basicUdiDi>
    <tradeName>ULTRAMED OXYGEN FACE MASK (With Non-Rebreathing Bag) (Adult Standard)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2008-01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-20T13:57:16.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004253355</udiDi>
    <basicUdiDi>622300425OFM2004TL</basicUdiDi>
    <tradeName>ULTRAMED OXYGEN FACE MASK (With Non-Rebreathing Bag) (Paediatric Standard)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2008-02</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-20T13:57:16.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004253454</udiDi>
    <basicUdiDi>622300425OFM2007TS</basicUdiDi>
    <tradeName>ULTRAMED OXYGEN FACE MASK (With Nebulizer) (Neonates)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2007-03</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-20T13:57:15.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>06223004254932</udiDi>
    <basicUdiDi>622300425OFM2004TL</basicUdiDi>
    <tradeName>ULTRAMED OXYGEN FACE MASK (Medium Concentration With Tube) (Neonates)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)</manufacturerName>
    <manufacturerSrn>EG-MF-000038562</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2004-04</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-20T13:56:56.458Z</lastUpdated>
  </row>
</eudamedExport>