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<eudamedExport entity="devices">
  <row>
    <udiDi>00606959062429</udiDi>
    <basicUdiDi>B-00606959062429</basicUdiDi>
    <tradeName>Dreamwear Under the Nose/Silicone Pillows Frame Kit Small</tradeName>
    <deviceName>Dreamwear Under the Nose/Silicone Pillows Frame Kit Small</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1148932</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:21.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062153</udiDi>
    <basicUdiDi>B-00606959062153</basicUdiDi>
    <tradeName>DreamWear Silicone Pillows, FitPack Russian Corridor</tradeName>
    <deviceName>DreamWear Silicone Pillows, FitPack Russian Corridor</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146469RC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:20.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062146</udiDi>
    <basicUdiDi>B-00606959062146</basicUdiDi>
    <tradeName>DreamWear Silicone Pillows, FitPack Central Europe</tradeName>
    <deviceName>DreamWear Silicone Pillows, FitPack Central Europe</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146469CE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:19.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062108</udiDi>
    <basicUdiDi>B-00606959062108</basicUdiDi>
    <tradeName>S, DreamWear Silicone Pillows, Small Frame with Headgear, Asain Pacific</tradeName>
    <deviceName>S, DreamWear Silicone Pillows, Small Frame with Headgear, Asain Pacific</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146410AP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:18.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959061088</udiDi>
    <basicUdiDi>B-00606959061088</basicUdiDi>
    <tradeName>MW, DreamWearFull, Sm and Med Frm, UK</tradeName>
    <deviceName>MW, DreamWearFull, Sm and Med Frm, UK</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1133373UA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:14.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959061071</udiDi>
    <basicUdiDi>B-00606959061071</basicUdiDi>
    <tradeName>L, DreamWear Full, Sm &amp; Med Frm, INTL</tradeName>
    <deviceName>L, DreamWear Full, Sm &amp; Med Frm, INTL</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1133372UA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:13.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060975</udiDi>
    <basicUdiDi>B-00606959060975</basicUdiDi>
    <tradeName>DreamWear SP, Demo Pack</tradeName>
    <deviceName>DreamWear SP, Demo Pack</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146471</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:13.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060968</udiDi>
    <basicUdiDi>B-00606959060968</basicUdiDi>
    <tradeName>DreamWear SP, Setup Pack</tradeName>
    <deviceName>DreamWear SP, Setup Pack</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146470</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:12.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060883</udiDi>
    <basicUdiDi>B-00606959060883</basicUdiDi>
    <tradeName>L, DreamWear SP, Lg Frm W/O HGR,GBL</tradeName>
    <deviceName>L, DreamWear SP, Lg Frm W/O HGR,GBL</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146463</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:08.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060944</udiDi>
    <basicUdiDi>B-00606959060944</basicUdiDi>
    <tradeName>DreamWear SP, FitPack, GBL</tradeName>
    <deviceName>DreamWear SP, FitPack, GBL</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146468</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:07.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060890</udiDi>
    <basicUdiDi>B-00606959060890</basicUdiDi>
    <tradeName>DreamWear Silicone Pillows MW, L Frame W/O Headgear, Global</tradeName>
    <deviceName>DreamWear Silicone Pillows MW, L Frame W/O Headgear, Global</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146464</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:06.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060876</udiDi>
    <basicUdiDi>B-00606959060876</basicUdiDi>
    <tradeName>M, DreamWear SP, Lg Frm W/O HGR, GBL</tradeName>
    <deviceName>M, DreamWear SP, Lg Frm W/O HGR, GBL</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146462</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:51.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060869</udiDi>
    <basicUdiDi>B-00606959060869</basicUdiDi>
    <tradeName>S, DreamWear SP, Lg Frm W/O HGR, GBL</tradeName>
    <deviceName>S, DreamWear SP, Lg Frm W/O HGR, GBL</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146461</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:49.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060852</udiDi>
    <basicUdiDi>B-00606959060852</basicUdiDi>
    <tradeName>MW, DreamWear SP, Med Frm W/O HGR, GBL</tradeName>
    <deviceName>MW, DreamWear SP, Med Frm W/O HGR, GBL</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146460</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:49.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060845</udiDi>
    <basicUdiDi>B-00606959060845</basicUdiDi>
    <tradeName>L, DreamWear SP, Med Frm W/O HGR, GBL</tradeName>
    <deviceName>L, DreamWear SP, Med Frm W/O HGR, GBL</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146459</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:47.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060838</udiDi>
    <basicUdiDi>B-00606959060838</basicUdiDi>
    <tradeName>M, DreamWear SP, Med Frm W/O HGR, GBL</tradeName>
    <deviceName>M, DreamWear SP, Med Frm W/O HGR, GBL</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146458</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:45.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060821</udiDi>
    <basicUdiDi>B-00606959060821</basicUdiDi>
    <tradeName>S, DreamWear SP, Med Frm W/O HGR, GBL</tradeName>
    <deviceName>S, DreamWear SP, Med Frm W/O HGR, GBL</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146457</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:43.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060814</udiDi>
    <basicUdiDi>B-00606959060814</basicUdiDi>
    <tradeName>MW, DreamWear SP, Sm Frm W/O HGR, GBL</tradeName>
    <deviceName>MW, DreamWear SP, Sm Frm W/O HGR, GBL</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146456</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:42.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060807</udiDi>
    <basicUdiDi>B-00606959060807</basicUdiDi>
    <tradeName>L, DreamWear SP, Sm Frm W/O HGR, GBL</tradeName>
    <deviceName>L, DreamWear SP, Sm Frm W/O HGR, GBL</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146455</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:41.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060791</udiDi>
    <basicUdiDi>B-00606959060791</basicUdiDi>
    <tradeName>M, DreamWear SP, Sm Frm W/O HGR, GBL</tradeName>
    <deviceName>M, DreamWear SP, Sm Frm W/O HGR, GBL</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146454</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:38.657Z</lastUpdated>
  </row>
</eudamedExport>