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<eudamedExport entity="devices">
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    <udiDi>06945934603405</udiDi>
    <basicUdiDi>B-06945934603405</basicUdiDi>
    <tradeName>oxygen mask nebulizer type</tradeName>
    <deviceName>Oxygen mask nebulizer type S</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-D02-S</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:23.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931515061047</udiDi>
    <basicUdiDi>69315150MW107JD</basicUdiDi>
    <tradeName>06931515061047</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOSPITAL&amp;HOMECARE IMP. &amp; EXP. CO.,LTD NANJING</manufacturerName>
    <manufacturerSrn>CN-MF-000038483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MW10702001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T17:01:18.596Z</lastUpdated>
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    <udiDi>06931515061054</udiDi>
    <basicUdiDi>69315150MW107JD</basicUdiDi>
    <tradeName>06931515061054</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOSPITAL&amp;HOMECARE IMP. &amp; EXP. CO.,LTD NANJING</manufacturerName>
    <manufacturerSrn>CN-MF-000038483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MW10703001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T17:01:18.586Z</lastUpdated>
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    <udiDi>06931515061061</udiDi>
    <basicUdiDi>69315150MW107JD</basicUdiDi>
    <tradeName>06931515061061</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOSPITAL&amp;HOMECARE IMP. &amp; EXP. CO.,LTD NANJING</manufacturerName>
    <manufacturerSrn>CN-MF-000038483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MW10704001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T17:01:18.573Z</lastUpdated>
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  <row>
    <udiDi>06931515061122</udiDi>
    <basicUdiDi>69315150MW107JD</basicUdiDi>
    <tradeName>06931515061122</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOSPITAL&amp;HOMECARE IMP. &amp; EXP. CO.,LTD NANJING</manufacturerName>
    <manufacturerSrn>CN-MF-000038483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MW10701001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T17:01:18.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931515061139</udiDi>
    <basicUdiDi>69315150MW107JD</basicUdiDi>
    <tradeName>06931515061139</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOSPITAL&amp;HOMECARE IMP. &amp; EXP. CO.,LTD NANJING</manufacturerName>
    <manufacturerSrn>CN-MF-000038483</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MW10703001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T17:01:18.487Z</lastUpdated>
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  <row>
    <udiDi>06934325308128</udiDi>
    <basicUdiDi>69343253R03010332E78</basicUdiDi>
    <tradeName>06934325308128</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>A01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:55:54.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934325308142</udiDi>
    <basicUdiDi>69343253R03010332E78</basicUdiDi>
    <tradeName>06934325308142</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>K01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:55:53.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382602516</udiDi>
    <basicUdiDi>697209192ASM02GD</basicUdiDi>
    <tradeName>Medocare Nebulizer Mask</tradeName>
    <deviceName>Nebulizer with Aerosol Masks</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10503001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:09:24.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942382602486</udiDi>
    <basicUdiDi>697209192ASM02GD</basicUdiDi>
    <tradeName>Medocare Nebulizer Mask</tradeName>
    <deviceName>Nebulizer with Aerosol Masks</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10501001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-26T17:09:23.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942284617199</udiDi>
    <basicUdiDi>6970392211NK00023F</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName>Nebulizer kit</deviceName>
    <manufacturerName>JOYTECH Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006020</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>NK-401</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:20:25.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942284617038</udiDi>
    <basicUdiDi>6970392211NK00013D</basicUdiDi>
    <tradeName>Nebulizer kit</tradeName>
    <deviceName>Nebulizer Kit</deviceName>
    <manufacturerName>JOYTECH Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006020</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>NK-101</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:20:22.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934325308135</udiDi>
    <basicUdiDi>69343253R03010332E78</basicUdiDi>
    <tradeName>06934325308135</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>S2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:47:40.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980103650</udiDi>
    <basicUdiDi>69239801FD2AAKN</basicUdiDi>
    <tradeName>RF1 Nebulizer w/ATV, 1.6M Tube</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:05.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980104510</udiDi>
    <basicUdiDi>69239801FD2ACKS</basicUdiDi>
    <tradeName>Neb.Easy AM-2 Mask, Adult w/Tube</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0054</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:04.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105401</udiDi>
    <basicUdiDi>69239801FD2AAKN</basicUdiDi>
    <tradeName>RF1 Nebulizer w/Valve T Kit, 22F, 22M</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105449</udiDi>
    <basicUdiDi>69239801FD2AFKY</basicUdiDi>
    <tradeName>Neb.Easy Nebulizer Kit</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0044</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105463</udiDi>
    <basicUdiDi>69239801FD2ACKS</basicUdiDi>
    <tradeName>Neb.Easy AM-1 Mask, Adult w/Tube</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105470</udiDi>
    <basicUdiDi>69239801FD2ACKS</basicUdiDi>
    <tradeName>Neb.Easy AM-1 Mask, Adult w/Tube</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105487</udiDi>
    <basicUdiDi>69239801FD2ACKS</basicUdiDi>
    <tradeName>Neb.Easy AM-1 Mask, Child w/Tube</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0051</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.781Z</lastUpdated>
  </row>
</eudamedExport>