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<eudamedExport entity="devices">
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    <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>
  <row>
    <udiDi>00606959060203</udiDi>
    <basicUdiDi>B-00606959060203</basicUdiDi>
    <tradeName>MW, Therapy Mask 3100 NC, w/HGR, GBL Nasal cushion</tradeName>
    <deviceName>MW, 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>1145462</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:50.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060197</udiDi>
    <basicUdiDi>B-00606959060197</basicUdiDi>
    <tradeName>M, Therapy Mask 3100 NC, w/HGR, GBL</tradeName>
    <deviceName>M, Therapy Mask 3100 NC, 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>1145461</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:49.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060180</udiDi>
    <basicUdiDi>B-00606959060180</basicUdiDi>
    <tradeName>S, Therapy Mask 3100 NC, w/HGR, GBL Nasal cushion</tradeName>
    <deviceName>S, 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>1145460</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:48.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060173</udiDi>
    <basicUdiDi>B-00606959060173</basicUdiDi>
    <tradeName>XS, Therapy Mask 3100 NC, w/HGR, GBL Nasal cushion</tradeName>
    <deviceName>XS, 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>1145459</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:44.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060142</udiDi>
    <basicUdiDi>B-00606959060142</basicUdiDi>
    <tradeName>Therapy Mask 3100 NC-SP, demopack, GBL Nasal cushionsilicone pillows</tradeName>
    <deviceName>Therapy Mask 3100 NC-SP, demopack, GBL Nasal cushionsilicone 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>1145060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:44.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060067</udiDi>
    <basicUdiDi>B-00606959060067</basicUdiDi>
    <tradeName>Therapy Mask 3100 SP, fitpack, w/HGR, AP Silicone pillows</tradeName>
    <deviceName>Therapy Mask 3100 SP, fitpack, w/HGR, AP 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>1145052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:43.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060050</udiDi>
    <basicUdiDi>B-00606959060050</basicUdiDi>
    <tradeName>Therapy Mask 3100 SP, fitpack, w/HGR, RC Silicone pillows</tradeName>
    <deviceName>Therapy Mask 3100 SP, fitpack, w/HGR, RC 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>1145051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:42.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060043</udiDi>
    <basicUdiDi>B-00606959060043</basicUdiDi>
    <tradeName>Therapy Mask 3100 SP, fitpack, w/HGR, CE Silicone pillows</tradeName>
    <deviceName>Therapy Mask 3100 SP, fitpack, w/HGR, CE 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>1145050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:38.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060036</udiDi>
    <basicUdiDi>B-00606959060036</basicUdiDi>
    <tradeName>Therapy Mask 3100 SP, fitpack,w/HGR, INT Silicone pillows</tradeName>
    <deviceName>Therapy Mask 3100 SP, fitpack,w/HGR, INT 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>1145049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:37.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959059955</udiDi>
    <basicUdiDi>B-00606959059955</basicUdiDi>
    <tradeName>Therapy Mask 3100 NC, fitpack, w/HGR, AP Nasal cushion</tradeName>
    <deviceName>Therapy Mask 3100 NC, fitpack, w/HGR, AP 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>1145041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:36.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959059948</udiDi>
    <basicUdiDi>B-00606959059948</basicUdiDi>
    <tradeName>Therapy Mask 3100 NC, fitpack, w/HGR, RC Nasal cushion</tradeName>
    <deviceName>Therapy Mask 3100 NC, fitpack, w/HGR, RC 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>1145040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:36.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959059931</udiDi>
    <basicUdiDi>B-00606959059931</basicUdiDi>
    <tradeName>Therapy Mask 3100 NC, fitpack, w/HGR, INT Nasal cushion</tradeName>
    <deviceName>Therapy Mask 3100 NC, fitpack, w/HGR, INT 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>1145038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:31.362Z</lastUpdated>
  </row>
</eudamedExport>