<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>00606959046313</udiDi>
    <basicUdiDi>B-00606959046313</basicUdiDi>
    <tradeName>Small DreamWear Full Mask with Sm-Medium Frame, INTL</tradeName>
    <deviceName>Small DreamWear Full Mask with Sm-Medium 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>1133370</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:22:08.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959046306</udiDi>
    <basicUdiDi>B-00606959046306</basicUdiDi>
    <tradeName>MW DreamWear Full Mask w/Sm-Med Frame, Global</tradeName>
    <deviceName>MW DreamWear Full Mask w/Sm-Med Frame, 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>1133378</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:22:07.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959046290</udiDi>
    <basicUdiDi>B-00606959046290</basicUdiDi>
    <tradeName>Large DreamWear Full Mask with Sm-Med Frame, Global</tradeName>
    <deviceName>Large DreamWear Full Mask with Sm-Med Frame, 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>1133377</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:22:06.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959046283</udiDi>
    <basicUdiDi>B-00606959046283</basicUdiDi>
    <tradeName>M DreamWear Full Mask with Sm-Med Frame, Global</tradeName>
    <deviceName>M DreamWear Full Mask with Sm-Med Frame, 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>1133376</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:22:02.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959046276</udiDi>
    <basicUdiDi>B-00606959046276</basicUdiDi>
    <tradeName>Small DreamWear Full Mask with Sm-Med Frame, Global</tradeName>
    <deviceName>Small DreamWear Full Mask with Sm-Med Frame, 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>1133375</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:22:01.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959046146</udiDi>
    <basicUdiDi>B-00606959046146</basicUdiDi>
    <tradeName>MW DreamWear Full Mask w/L Frame w/Headgear, Global</tradeName>
    <deviceName>MW DreamWear Full Mask w/L Frame w/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>1133393</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:22:00.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959046139</udiDi>
    <basicUdiDi>B-00606959046139</basicUdiDi>
    <tradeName>L DreamWear Full Mask w/L Frame w/Headgear, Global</tradeName>
    <deviceName>L DreamWear Full Mask w/L Frame w/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>1133392</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:22:00.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959046122</udiDi>
    <basicUdiDi>B-00606959046122</basicUdiDi>
    <tradeName>M DreamWear Full Mask w/L Frame w/Headgear, Global</tradeName>
    <deviceName>M DreamWear Full Mask w/L Frame w/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>1133391</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:21:56.004Z</lastUpdated>
  </row>
</eudamedExport>