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<eudamedExport entity="devices">
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    <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>
  <row>
    <udiDi>00606959057494</udiDi>
    <basicUdiDi>B-00606959057494</basicUdiDi>
    <tradeName>WISP PEDIATRIC NASAL MASK, CE</tradeName>
    <deviceName>WISP PEDIATRIC NASAL MASK, CE</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>1104961CE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:17.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959056800</udiDi>
    <basicUdiDi>B-00606959056800</basicUdiDi>
    <tradeName>Small Medium DreamWear Nasal Mask Kit, with Headgear, Global</tradeName>
    <deviceName>Small Medium DreamWear Nasal Mask Kit, with 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>1142376</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:17.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959048096</udiDi>
    <basicUdiDi>B-00606959048096</basicUdiDi>
    <tradeName>AF531 Mask w/SE, w/Reduced Size 4 PT Headgear, SU, Medium</tradeName>
    <deviceName>AF531 Mask w/SE, w/Reduced Size 4 PT Headgear, SU, Medium</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>1134714</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:15.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959047082</udiDi>
    <basicUdiDi>B-00606959047082</basicUdiDi>
    <tradeName>L Amara View Mask w/HGR, IBERIA</tradeName>
    <deviceName>L Amara View Mask w/HGR, IBERIA</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>ES1090664</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:11.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959047075</udiDi>
    <basicUdiDi>B-00606959047075</basicUdiDi>
    <tradeName>M Amara View Mask w/HGR, IBERIA</tradeName>
    <deviceName>M Amara View Mask w/HGR, IBERIA</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>ES1090663</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:10.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959047068</udiDi>
    <basicUdiDi>B-00606959047068</basicUdiDi>
    <tradeName>S Amara View Mask w/HGR, IBERIA</tradeName>
    <deviceName>S Amara View Mask w/HGR, IBERIA</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>ES1090662</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:09.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959047051</udiDi>
    <basicUdiDi>B-00606959047051</basicUdiDi>
    <tradeName>Wisp SE Mask, Clear Frame w/HDGR, INTL</tradeName>
    <deviceName>Wisp SE Mask, Clear Frame w/HDGR, 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>ES1094062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:27:08.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959047044</udiDi>
    <basicUdiDi>B-00606959047044</basicUdiDi>
    <tradeName>Wisp Mask, Fabric Frame w/HDGR, INTL</tradeName>
    <deviceName>Wisp Mask, Fabric Frame w/HDGR, 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>ES1094061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:22:15.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959047037</udiDi>
    <basicUdiDi>B-00606959047037</basicUdiDi>
    <tradeName>Wisp Mask, Clear Frame w/HDGR, INTL</tradeName>
    <deviceName>Wisp Mask, Clear Frame w/HDGR, 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>ES1094060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:22:14.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959046344</udiDi>
    <basicUdiDi>B-00606959046344</basicUdiDi>
    <tradeName>MW, DreamWear Full, Sm &amp; Med Frm, INTL</tradeName>
    <deviceName>MW, 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>1133373</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:22:13.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959046337</udiDi>
    <basicUdiDi>B-00606959046337</basicUdiDi>
    <tradeName>Large DreamWear Full Mask with Sm-Med Frame, INTL</tradeName>
    <deviceName>Large DreamWear Full Mask with Sm-Med Frame, 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>1133372</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:22:12.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959046320</udiDi>
    <basicUdiDi>B-00606959046320</basicUdiDi>
    <tradeName>M DreamWear Full Mask with Sm-Med Frame, INTL</tradeName>
    <deviceName>M DreamWear Full Mask with Sm-Med Frame, 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>1133371</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:22:08.818Z</lastUpdated>
  </row>
</eudamedExport>