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<eudamedExport entity="devices">
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    <udiDi>04719872744283</udiDi>
    <basicUdiDi>471987274RAX-XXX5K</basicUdiDi>
    <tradeName>CPAP Tubing</tradeName>
    <deviceName>CPAP Tubing</deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010204</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION TUBINGS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>RAC-201</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:36:33.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719872744290</udiDi>
    <basicUdiDi>471987274CHS-XXLW</basicUdiDi>
    <tradeName>Head Strip</tradeName>
    <deviceName>Head Strip</deviceName>
    <manufacturerName>Acare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000031298</manufacturerSrn>
    <authorisedRepresentativeName>Surpass Biomedical Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000038619</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010401</emdnCode>
    <emdnDescription>CPAP HELMETS AND KITS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>CHS-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:36:33.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770662305</udiDi>
    <basicUdiDi>4716770CP06600DR</basicUdiDi>
    <tradeName>Cardiopulmonary Resuscitation Pocket Resuscitator Set</tradeName>
    <deviceName>CPR Pocket Resuscitator Set</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-66230</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:33:40.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770636030</udiDi>
    <basicUdiDi>4716770CA0630179</basicUdiDi>
    <tradeName>FitMax® CPAP Total Face Mask with Standard Elbow and Corrugate Tube, Size: XS</tradeName>
    <deviceName>FitMax® CPAP Total Face Mask with Standard Elbow and Corrugate Tube, Size: XS</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>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA-63603</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:33:36.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716770382005</udiDi>
    <basicUdiDi>4716770MD03800DU</basicUdiDi>
    <tradeName>MDI Spacer, 220 ml, adult</tradeName>
    <deviceName>MDI Spacer, Silicone mask, 220 ml, adult</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010302</emdnCode>
    <emdnDescription>AEROSOL PORTABLE INHALERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD-38200</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:33:31.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810085062</udiDi>
    <basicUdiDi>471081008NNED8B</basicUdiDi>
    <tradeName>Neb.Easy Nebulizer Kit</tradeName>
    <deviceName>Nebulizer Kit</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0044</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:01.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712832461558</udiDi>
    <basicUdiDi>471283246DRTFDA</basicUdiDi>
    <tradeName>04712832461558</tradeName>
    <deviceName>Respirators</deviceName>
    <manufacturerName>Aero Pro Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000012343</manufacturerSrn>
    <authorisedRepresentativeName>KOMAS Medical Technology GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045617</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP22103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:28:40.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711064682939</udiDi>
    <basicUdiDi>47126880500007258RPASY</basicUdiDi>
    <tradeName>04711064682939</tradeName>
    <deviceName>Respiratory accessories</deviceName>
    <manufacturerName>Hsiner Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007258</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00003456</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:27:29.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810101649</udiDi>
    <basicUdiDi>471081008NNAM8H</basicUdiDi>
    <tradeName>Headgear for Nasal Mask, White</tradeName>
    <deviceName>Disposable Headgear</deviceName>
    <manufacturerName>GaleMed Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000022411</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030180</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0079</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:42.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810100673</udiDi>
    <basicUdiDi>471081008NND67E</basicUdiDi>
    <tradeName>NHF Prong Kit, #1</tradeName>
    <deviceName>NHF Prong Kit</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>AO0113</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:41.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810089053</udiDi>
    <basicUdiDi>471081008NND87J</basicUdiDi>
    <tradeName>Gas Sampling Line, 300cm, 4F, 4M</tradeName>
    <deviceName>Gas Sampling Line</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>AB0060</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:36.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810083969</udiDi>
    <basicUdiDi>471081008NND97L</basicUdiDi>
    <tradeName>Flow Meter Adaptor, White</tradeName>
    <deviceName>Connector</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>AO0076</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:20.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810083174</udiDi>
    <basicUdiDi>471081008NNMM9M</basicUdiDi>
    <tradeName>PEP Aircushion Mask, L</tradeName>
    <deviceName>CPAP 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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0036</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:14.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082962</udiDi>
    <basicUdiDi>471081008NNE279</basicUdiDi>
    <tradeName>Neb.Easy Nebulizer, 18M</tradeName>
    <deviceName>Nebulizer</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:10.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082788</udiDi>
    <basicUdiDi>471081008NNE37B</basicUdiDi>
    <tradeName>AM-2 Aerosol Mask, Child</tradeName>
    <deviceName>Aerosol Mask &amp; Connector</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>R03010301</emdnCode>
    <emdnDescription>AEROSOL THERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD0068</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:25:06.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082573</udiDi>
    <basicUdiDi>471081008NND57C</basicUdiDi>
    <tradeName>AM-4 Trachea Mask, Adult</tradeName>
    <deviceName>Trachea 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>R03010202</emdnCode>
    <emdnDescription>VENTURI MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AO0006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:24:59.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082092</udiDi>
    <basicUdiDi>471081008NND276</basicUdiDi>
    <tradeName>OM-2 Mask, Child</tradeName>
    <deviceName>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>AO0005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:24:30.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082085</udiDi>
    <basicUdiDi>471081008NNE47D</basicUdiDi>
    <tradeName>LVN Nebulizer, PP</tradeName>
    <deviceName>LVN Nebulizer Kit</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>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH0032</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:24:29.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710810082054</udiDi>
    <basicUdiDi>471081008NND174</basicUdiDi>
    <tradeName>C22 Star Lumen Tubing, 1000cm</tradeName>
    <deviceName>Oxygen Tubing</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>AO0065</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:24:24.396Z</lastUpdated>
  </row>
  <row>
    <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>
</eudamedExport>