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<eudamedExport entity="devices">
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    <udiDi>00606959060784</udiDi>
    <basicUdiDi>B-00606959060784</basicUdiDi>
    <tradeName>S, DreamWear SP, Sm Frm W/O HGR, GBL</tradeName>
    <deviceName>S, 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>1146453</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:37.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060760</udiDi>
    <basicUdiDi>B-00606959060760</basicUdiDi>
    <tradeName>MW, DreamWear SP, Lg Frm W/ HGR, GBL</tradeName>
    <deviceName>MW, DreamWear SP, Lg Frm W/ 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>1146451</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:36.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060753</udiDi>
    <basicUdiDi>B-00606959060753</basicUdiDi>
    <tradeName>L, DreamWear SP, Lg Frm W/ HGR,</tradeName>
    <deviceName>L, DreamWear SP, Lg Frm W/ HGR,</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>1146450</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:34.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060746</udiDi>
    <basicUdiDi>B-00606959060746</basicUdiDi>
    <tradeName>M, DreamWear SP, Lg Frm W/ HGR, GBL</tradeName>
    <deviceName>M, DreamWear SP, Lg Frm W/ 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>1146449</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:32.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060739</udiDi>
    <basicUdiDi>B-00606959060739</basicUdiDi>
    <tradeName>S, DreamWear SP, Lg Frm W/ HGR, GBL</tradeName>
    <deviceName>S, DreamWear SP, Lg Frm W/ 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>1146448</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:30.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060722</udiDi>
    <basicUdiDi>B-00606959060722</basicUdiDi>
    <tradeName>MW, DreamWear SP, Med Frm W/ HGR, GBL</tradeName>
    <deviceName>MW, DreamWear SP, Med Frm W/ 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>1146417</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:29.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060715</udiDi>
    <basicUdiDi>B-00606959060715</basicUdiDi>
    <tradeName>L, DreamWear SP, Med Frm W/ HGR, GBL</tradeName>
    <deviceName>L, DreamWear SP, Med Frm W/ 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>1146416</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:28.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060708</udiDi>
    <basicUdiDi>B-00606959060708</basicUdiDi>
    <tradeName>M, DreamWear SP, Med Frm W/ HGR, GBL</tradeName>
    <deviceName>M, DreamWear SP, Med Frm W/ 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>1146415</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:25.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060692</udiDi>
    <basicUdiDi>B-00606959060692</basicUdiDi>
    <tradeName>DreamWear Silicone Pillows Mask,Sm, w/MedFrame,w/Hgr,Global</tradeName>
    <deviceName>DreamWear Silicone Pillows Mask,Sm, w/MedFrame,w/Hgr,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>1146414</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:23.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060685</udiDi>
    <basicUdiDi>B-00606959060685</basicUdiDi>
    <tradeName>MW, DreamWear SP, Sm Frm W/ HGR, GBL</tradeName>
    <deviceName>MW, DreamWear SP, Sm Frm W/ 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>1146413</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:22.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060678</udiDi>
    <basicUdiDi>B-00606959060678</basicUdiDi>
    <tradeName>L, DreamWear SP, Sm Frm W/ HGR, GBL</tradeName>
    <deviceName>L, DreamWear SP, Sm Frm W/ 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>1146412</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:21.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060661</udiDi>
    <basicUdiDi>B-00606959060661</basicUdiDi>
    <tradeName>M, DreamWear SP, Sm Frm W/ HGR, GBL</tradeName>
    <deviceName>M, DreamWear SP, Sm Frm W/ 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>1146411</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:18.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060654</udiDi>
    <basicUdiDi>B-00606959060654</basicUdiDi>
    <tradeName>S, DreamWear SP, Sm Frm W/ HGR, GBL</tradeName>
    <deviceName>S, DreamWear SP, Sm Frm W/ 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>1146410</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:17.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060289</udiDi>
    <basicUdiDi>B-00606959060289</basicUdiDi>
    <tradeName>Therapy Mask 3100 NC, fitpack, w/HGR, CE Nasal cushion</tradeName>
    <deviceName>Therapy Mask 3100 NC, fitpack, w/HGR, CE Nasal cushion</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>1145039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:16.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060265</udiDi>
    <basicUdiDi>B-00606959060265</basicUdiDi>
    <tradeName>L, Therapy Mask 3100 SP, w/HGR, GBL Silicone pillows</tradeName>
    <deviceName>L, Therapy Mask 3100 SP, w/HGR, GBL Silicone pillows</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>1145478</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:14.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060234</udiDi>
    <basicUdiDi>B-00606959060234</basicUdiDi>
    <tradeName>S, Therapy Mask 3100 SP, w/HGR, GBL Silicone pillows</tradeName>
    <deviceName>S, Therapy Mask 3100 SP, w/HGR, GBL Silicone pillows</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>1145465</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:12.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060258</udiDi>
    <basicUdiDi>B-00606959060258</basicUdiDi>
    <tradeName>MW, Therapy Mask 3100 SP, w/HGR, GBL Silicone pillows</tradeName>
    <deviceName>MW, Therapy Mask 3100 SP, w/HGR, GBL Silicone pillows</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>1145467</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:10.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060241</udiDi>
    <basicUdiDi>B-00606959060241</basicUdiDi>
    <tradeName>M, Therapy Mask 3100 SP, w/HGR, GBL Silicone pillows</tradeName>
    <deviceName>M, Therapy Mask 3100 SP, w/HGR, GBL Silicone pillows</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>1145466</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:09.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060227</udiDi>
    <basicUdiDi>B-00606959060227</basicUdiDi>
    <tradeName>XS, Therapy Mask 3100 SP, w/HGR, GBL Silicone pillows</tradeName>
    <deviceName>XS, Therapy Mask 3100 SP, w/HGR, GBL Silicone pillows</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>1145464</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:07.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060210</udiDi>
    <basicUdiDi>B-00606959060210</basicUdiDi>
    <tradeName>L, Therapy Mask 3100 NC, w/HGR, GBL Nasal cushion</tradeName>
    <deviceName>L, Therapy Mask 3100 NC, w/HGR, GBL Nasal cushion</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>1145463</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:51.387Z</lastUpdated>
  </row>
</eudamedExport>