<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959030862</udiDi>
    <basicUdiDi>B-00606959030862</basicUdiDi>
    <tradeName>S DreamWear Under Nose Mask, L Frame w/Headgr, Global</tradeName>
    <deviceName>S DreamWear Under Nose Mask, L Frame w/Headgr, 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>1116690</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:52.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959030824</udiDi>
    <basicUdiDi>B-00606959030824</basicUdiDi>
    <tradeName>M DreamWear Under Nose Mask, S Frame with Headgear, Global</tradeName>
    <deviceName>M DreamWear Under Nose Mask, S Frame 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>1116686</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:51.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959030787</udiDi>
    <basicUdiDi>B-00606959030787</basicUdiDi>
    <tradeName>S DreamWear Under Nose Mask, S Frame w/Headgr, Global</tradeName>
    <deviceName>S DreamWear Under Nose Mask, S Frame w/Headgr, 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>1116685</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:36.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029194</udiDi>
    <basicUdiDi>B-00606959029194</basicUdiDi>
    <tradeName>S DreamWear Under Nose Mask, M Frame w/Headgr, Global</tradeName>
    <deviceName>S DreamWear Under Nose Mask, M Frame w/Headgr, 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>1116680</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:35.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026766</udiDi>
    <basicUdiDi>B-00606959026766</basicUdiDi>
    <tradeName>Wisp Ped SE Elbow Accessory</tradeName>
    <deviceName>Wisp Ped SE Elbow Accessory</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>1104976</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:31.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026735</udiDi>
    <basicUdiDi>B-00606959026735</basicUdiDi>
    <tradeName>Wisp Ped Fit Pack w/Headgear – EE INT</tradeName>
    <deviceName>Wisp Ped Fit Pack w/Headgear – EE INT</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>1104961</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:30.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959025257</udiDi>
    <basicUdiDi>B-00606959025257</basicUdiDi>
    <tradeName>AMARA Mask SE with RS Frame AND Headgear INTL, LARGE</tradeName>
    <deviceName>AMARA Mask SE with RS Frame AND Headgear INTL, LARGE</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>1090436</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:30.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959025240</udiDi>
    <basicUdiDi>B-00606959025240</basicUdiDi>
    <tradeName>AMARA GEL Mask SE with RS Frame AND Headgear INTL,MEDIUM</tradeName>
    <deviceName>AMARA GEL Mask SE with RS Frame AND Headgear INTL,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>1090435</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:29.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959025226</udiDi>
    <basicUdiDi>B-00606959025226</basicUdiDi>
    <tradeName>AMARA GEL Mask SE with RS Frame AND Headgear INTL, PETITE</tradeName>
    <deviceName>AMARA GEL Mask SE with RS Frame AND Headgear INTL, PETITE</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>1090430</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:25.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021280</udiDi>
    <basicUdiDi>B-00606959021280</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>1094062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:24.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021174</udiDi>
    <basicUdiDi>B-00606959021174</basicUdiDi>
    <tradeName>AMARA GEL Mask with RS Frame and Headgear INTL, MEDIUM</tradeName>
    <deviceName>AMARA GEL Mask with RS Frame and Headgear INTL, 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>1090425</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:23.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021167</udiDi>
    <basicUdiDi>B-00606959021167</basicUdiDi>
    <tradeName>AMARA GEL Mask with RS Frame and Headgear INTL, SMALL</tradeName>
    <deviceName>AMARA GEL Mask with RS Frame and Headgear INTL, SMALL</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>1090421</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:22.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959015036</udiDi>
    <basicUdiDi>B-00606959015036</basicUdiDi>
    <tradeName>Amara Mask with SE, Large, with RS Frame and Headgear, INTL</tradeName>
    <deviceName>Amara Mask with SE, Large, with RS Frame and Headgear, 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>1090236</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:18.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959015029</udiDi>
    <basicUdiDi>B-00606959015029</basicUdiDi>
    <tradeName>Amara Mask with SE, Medium, with RS Frame and Headgear, INTL</tradeName>
    <deviceName>Amara Mask with SE, Medium, with RS Frame and Headgear, 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>1090235</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:18.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959015012</udiDi>
    <basicUdiDi>B-00606959015012</basicUdiDi>
    <tradeName>Amara Mask with SE, Small, with RS Frame and Headgear, INTL</tradeName>
    <deviceName>Amara Mask with SE, Small, with RS Frame and Headgear, 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>1090231</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:17.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959015005</udiDi>
    <basicUdiDi>B-00606959015005</basicUdiDi>
    <tradeName>Amara Mask w/SE, Petite, w/RS Frame w/RS Headgr,INTL</tradeName>
    <deviceName>Amara Mask w/SE, Petite, w/RS Frame w/RS Headgr,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>1090230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:15.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959014961</udiDi>
    <basicUdiDi>B-00606959014961</basicUdiDi>
    <tradeName>Amara Mask with RS Frame and RS Headgear, Petite, INTL</tradeName>
    <deviceName>Amara Mask with RS Frame and RS Headgear, Petite, 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>1090220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:11.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959012479</udiDi>
    <basicUdiDi>B-00606959012479</basicUdiDi>
    <tradeName>ACC, PerforMax Ped EE Leak 1 Elbow, Single</tradeName>
    <deviceName>ACC, PerforMax Ped EE Leak 1 Elbow, Single</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>1119138</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:10.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959012424</udiDi>
    <basicUdiDi>B-00606959012424</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 2, with 4 PT Headgear, Large, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 2, with 4 PT Headgear, Large, SU</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>1119126</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:10.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959012417</udiDi>
    <basicUdiDi>B-00606959012417</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 2, with 4 PT Headgear, Medium, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 2, with 4 PT Headgear, Medium, SU</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>1119125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:09.328Z</lastUpdated>
  </row>
</eudamedExport>