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<eudamedExport entity="devices">
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    <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>
  <row>
    <udiDi>00606959059917</udiDi>
    <basicUdiDi>B-00606959059917</basicUdiDi>
    <tradeName>Therapy Mask 3100 SP, fitpack, w/HGR, GBL Silicone pillows</tradeName>
    <deviceName>Therapy Mask 3100 SP, fitpack, 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>1144610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:30.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959059894</udiDi>
    <basicUdiDi>B-00606959059894</basicUdiDi>
    <tradeName>Therapy Mask 3100 NC, FitPack, w/HGR, GBL Nasal cushion</tradeName>
    <deviceName>Therapy Mask 3100 NC, FitPack, 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>1144608</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:29.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959059832</udiDi>
    <basicUdiDi>B-00606959059832</basicUdiDi>
    <tradeName>L Dreamwear UTN Med Frame, and L full cu</tradeName>
    <deviceName>L Dreamwear UTN Med Frame, and L full cu</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>1144114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:28.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959059825</udiDi>
    <basicUdiDi>B-00606959059825</basicUdiDi>
    <tradeName>M Dreamwear UTN Med Frame, and M full cu</tradeName>
    <deviceName>M Dreamwear UTN Med Frame, and M full cu</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>1144113</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:24.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959059818</udiDi>
    <basicUdiDi>B-00606959059818</basicUdiDi>
    <tradeName>S Dreamwear UTN Med Frame, and S full cu</tradeName>
    <deviceName>S Dreamwear UTN Med Frame, and S full cu</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>1144112</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:24.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959058385</udiDi>
    <basicUdiDi>B-00606959058385</basicUdiDi>
    <tradeName>M, DreamWear Full, Sm &amp; Med Frm, Ukraine</tradeName>
    <deviceName>M, DreamWear Full, Sm &amp; Med Frm, Ukraine</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>1133371UA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:23.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959058378</udiDi>
    <basicUdiDi>B-00606959058378</basicUdiDi>
    <tradeName>S, DreamWear Full, Sm &amp; Med Frm, Ukraine</tradeName>
    <deviceName>S, DreamWear Full, Sm &amp; Med Frm, Ukraine</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>1133370UA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:22.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959058354</udiDi>
    <basicUdiDi>B-00606959058354</basicUdiDi>
    <tradeName>DreamWear Nasal Mask FIT PACK, Ukraine</tradeName>
    <deviceName>DreamWear Nasal Mask FIT PACK, Ukraine</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>1116696UA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:18.564Z</lastUpdated>
  </row>
</eudamedExport>