<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>00606959012400</udiDi>
    <basicUdiDi>B-00606959012400</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 2, with 4 PT Headgear, Small, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 2, with 4 PT Headgear, Small, 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>1119124</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:05.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959012127</udiDi>
    <basicUdiDi>B-00606959012127</basicUdiDi>
    <tradeName>AF531 Mask w/SE, and CapStrap, Large, Single Use</tradeName>
    <deviceName>AF531 Mask w/SE, and CapStrap, Large, Single Use</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>1119118</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:04.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959012110</udiDi>
    <basicUdiDi>B-00606959012110</basicUdiDi>
    <tradeName>AF531 Mask w/SE, and CapStrap, Medium, Single Use</tradeName>
    <deviceName>AF531 Mask w/SE, and CapStrap, Medium, Single Use</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>1119117</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:03.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959012103</udiDi>
    <basicUdiDi>B-00606959012103</basicUdiDi>
    <tradeName>AF531 Mask w/SE, and CapStrap, Small, Single Use</tradeName>
    <deviceName>AF531 Mask w/SE, and CapStrap, Small, Single Use</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>1119116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:02.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959012097</udiDi>
    <basicUdiDi>B-00606959012097</basicUdiDi>
    <tradeName>AF531 Mask w/SE, and 4 PT Headgear, Large, Single Use</tradeName>
    <deviceName>AF531 Mask w/SE, and 4 PT Headgear, Large, Single Use</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>1119115</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:58.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959012080</udiDi>
    <basicUdiDi>B-00606959012080</basicUdiDi>
    <tradeName>AF531 Mask w/SE, and 4 PT Headgear, Medium, Single Use</tradeName>
    <deviceName>AF531 Mask w/SE, and 4 PT Headgear, Medium, Single Use</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>1119114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:58.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959012073</udiDi>
    <basicUdiDi>B-00606959012073</basicUdiDi>
    <tradeName>AF531 Mask w/SE, and 4 PT Headgear, Small, Single Use</tradeName>
    <deviceName>AF531 Mask w/SE, and 4 PT Headgear, Small, Single Use</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>1119113</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:57.319Z</lastUpdated>
  </row>
</eudamedExport>