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    <basicUdiDi>619498EC1736Q</basicUdiDi>
    <tradeName>AIRFIT N20 MED SYS - EU2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63514</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T09:21:07.939Z</lastUpdated>
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  <row>
    <udiDi>00619498635153</udiDi>
    <basicUdiDi>619498EC1736Q</basicUdiDi>
    <tradeName>AIRFIT N20 LGE SYS - EU2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63515</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T09:21:07.919Z</lastUpdated>
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    <udiDi>00619498635160</udiDi>
    <basicUdiDi>619498EC1736Q</basicUdiDi>
    <tradeName>AIRFIT N20 SML (FOR HER) - EU3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63516</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T09:21:07.908Z</lastUpdated>
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    <udiDi>00619498635177</udiDi>
    <basicUdiDi>619498EC1736Q</basicUdiDi>
    <tradeName>AIRFIT N20 MED SYS - EU3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63517</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T09:21:07.894Z</lastUpdated>
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  <row>
    <udiDi>00619498635184</udiDi>
    <basicUdiDi>619498EC1736Q</basicUdiDi>
    <tradeName>AIRFIT N20 LGE SYS - EU3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ResMed PTY LTD</manufacturerName>
    <manufacturerSrn>AU-MF-000011753</manufacturerSrn>
    <authorisedRepresentativeName>ResMed SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000007151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63518</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T09:21:07.878Z</lastUpdated>
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  <row>
    <udiDi>04048675041139</udiDi>
    <basicUdiDi>0404867512080026K19X010NV</basicUdiDi>
    <tradeName>Maske ClassicStar,NIV,m.SE,GrL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01575</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:49:12.472Z</lastUpdated>
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  <row>
    <udiDi>06923980105562</udiDi>
    <basicUdiDi>69239801ND2HAP3</basicUdiDi>
    <tradeName>Nasal CPAP Mask, 15M, L w/Durable Headge</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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0065</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980107016</udiDi>
    <basicUdiDi>69239801ND2HAP3</basicUdiDi>
    <tradeName>Bi-level CPAP Mask w/port, L</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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:01.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980110498</udiDi>
    <basicUdiDi>69239801ND2HAP3</basicUdiDi>
    <tradeName>CPAP Face Mask Set w/Hose, M</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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0121</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.801Z</lastUpdated>
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  <row>
    <udiDi>06923980110504</udiDi>
    <basicUdiDi>69239801ND2HAP3</basicUdiDi>
    <tradeName>CPAP Face Mask Set w/Hose, S</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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0122</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:48.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980112751</udiDi>
    <basicUdiDi>69239801NR2KASE</basicUdiDi>
    <tradeName>NIV mask, large, including headgear</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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XMR0028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:46.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980112768</udiDi>
    <basicUdiDi>69239801NR2KASE</basicUdiDi>
    <tradeName>NIV mask, middle, including headgear</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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XMR0030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:46.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675041122</udiDi>
    <basicUdiDi>0404867512080026K19X010NV</basicUdiDi>
    <tradeName>Maske ClassicStar,NIV,m.SE,GrM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01574</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T06:14:19.478Z</lastUpdated>
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  <row>
    <udiDi>04048675250807</udiDi>
    <basicUdiDi>0404867512080026K19X020NY</basicUdiDi>
    <tradeName>Maske ClassicStar Nasal V, S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01620</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T06:14:18.021Z</lastUpdated>
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  <row>
    <udiDi>04048675250814</udiDi>
    <basicUdiDi>0404867512080026K19X020NY</basicUdiDi>
    <tradeName>Maske ClassicStar Nasal V, L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01622</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T06:14:18.002Z</lastUpdated>
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  <row>
    <udiDi>04048675250838</udiDi>
    <basicUdiDi>0404867512080026K19X020NY</basicUdiDi>
    <tradeName>Maske ClassicStar Nasal NV, M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01624</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T06:14:17.981Z</lastUpdated>
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  <row>
    <udiDi>04048675250845</udiDi>
    <basicUdiDi>0404867512080026K19X020NY</basicUdiDi>
    <tradeName>Maske ClassicStar Nasal NV, L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01625</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T06:14:17.961Z</lastUpdated>
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    <udiDi>04048675251705</udiDi>
    <basicUdiDi>0404867512080026K19Z000P8</basicUdiDi>
    <tradeName>Maske ClassicStar,NIV,mAAV,GrS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP01570</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T06:14:17.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>06922166514167</udiDi>
    <basicUdiDi>69221665YNM001QC</basicUdiDi>
    <tradeName>Nasal Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Yuyue Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015854</manufacturerSrn>
    <authorisedRepresentativeName>Metrax GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005481</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH03003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-23T14:20:25.160Z</lastUpdated>
  </row>
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    <udiDi>06922166514150</udiDi>
    <basicUdiDi>69221665YNM001QC</basicUdiDi>
    <tradeName>Nasal Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Yuyue Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015854</manufacturerSrn>
    <authorisedRepresentativeName>Metrax GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005481</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH03002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-23T14:20:23.954Z</lastUpdated>
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