<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959040052</udiDi>
    <basicUdiDi>B-00606959040052</basicUdiDi>
    <tradeName>P, Wisp Mask, Fabric Frame, w/HDGR, INTL</tradeName>
    <deviceName>P, 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>1093927</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:30.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959040045</udiDi>
    <basicUdiDi>B-00606959040045</basicUdiDi>
    <tradeName>XL, Wisp Mask, Clear Frame, w/HDGR, INTL</tradeName>
    <deviceName>XL, 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>1093926</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:26.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959040038</udiDi>
    <basicUdiDi>B-00606959040038</basicUdiDi>
    <tradeName>L, Wisp Mask, Clear Frame, w/HDGR, INTL</tradeName>
    <deviceName>L, 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>1093925</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:25.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959040021</udiDi>
    <basicUdiDi>B-00606959040021</basicUdiDi>
    <tradeName>S/M, Wisp Mask, Clear Frame, w/HDGR, INTL</tradeName>
    <deviceName>S/M, 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>1093924</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:24.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959040014</udiDi>
    <basicUdiDi>B-00606959040014</basicUdiDi>
    <tradeName>P, Wisp Mask, Clear Frame, w/HDGR, INTL</tradeName>
    <deviceName>P, 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>1093923</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:23.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959039995</udiDi>
    <basicUdiDi>B-00606959039995</basicUdiDi>
    <tradeName>Wisp Youth Nasal Mask, Fabric Frame, w/HDGR, INTL</tradeName>
    <deviceName>Wisp Youth Nasal 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>1109308</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:19.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959037625</udiDi>
    <basicUdiDi>B-00606959037625</basicUdiDi>
    <tradeName>XL Pico Traditional Nasal Mask w/HGR, INTL</tradeName>
    <deviceName>XL Pico Traditional Nasal Mask w/HGR, 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>1104923</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:19.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959037618</udiDi>
    <basicUdiDi>B-00606959037618</basicUdiDi>
    <tradeName>XL Pico Traditional Nasal Mask W/O HGR</tradeName>
    <deviceName>XL Pico Traditional Nasal Mask W/O HGR</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>1104920</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:18.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959037601</udiDi>
    <basicUdiDi>B-00606959037601</basicUdiDi>
    <tradeName>L Pico Traditional Nasal Mask W/O HGR</tradeName>
    <deviceName>L Pico Traditional Nasal Mask W/O HGR</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>1104919</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:17.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959037595</udiDi>
    <basicUdiDi>B-00606959037595</basicUdiDi>
    <tradeName>XL Pico Traditional Nasal Mask w/HGR</tradeName>
    <deviceName>XL Pico Traditional Nasal Mask w/HGR</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>1104917</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:13.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959037588</udiDi>
    <basicUdiDi>B-00606959037588</basicUdiDi>
    <tradeName>Fitpack S/M, L, XL Pico Traditional Nasal Mask w/HGR</tradeName>
    <deviceName>Fitpack S/M, L, XL Pico Traditional Nasal Mask w/HGR</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>1104940</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:12.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959037571</udiDi>
    <basicUdiDi>B-00606959037571</basicUdiDi>
    <tradeName>DreamWear Under Nose Mask, Med Frame w/Headgr, INTL</tradeName>
    <deviceName>DreamWear Under Nose Mask, Med Frame w/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>1116720</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:11.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959037564</udiDi>
    <basicUdiDi>B-00606959037564</basicUdiDi>
    <tradeName>DreamWear Under Nose Mask, Fitpack, NTL</tradeName>
    <deviceName>DreamWear Under Nose Mask, Fitpack, NTL</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>1116696</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:11.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959035898</udiDi>
    <basicUdiDi>B-00606959035898</basicUdiDi>
    <tradeName>L Pico Traditional Nasal Mask w/HGR, INTL</tradeName>
    <deviceName>L Pico Traditional Nasal Mask w/HGR, 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>1104922</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:07.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959035881</udiDi>
    <basicUdiDi>B-00606959035881</basicUdiDi>
    <tradeName>S/M Pico Traditional Nasal Mask w/HGR, INTL</tradeName>
    <deviceName>S/M Pico Traditional Nasal Mask w/HGR, 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>1104921</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:06.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959035874</udiDi>
    <basicUdiDi>B-00606959035874</basicUdiDi>
    <tradeName>S/M Pico Traditional Nasal Mask W/O HGR</tradeName>
    <deviceName>S/M Pico Traditional Nasal Mask W/O HGR</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>1104918</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:05.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959035867</udiDi>
    <basicUdiDi>B-00606959035867</basicUdiDi>
    <tradeName>L Pico Traditional Nasal Mask w/HGR</tradeName>
    <deviceName>L Pico Traditional Nasal Mask w/HGR</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>1104916</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:04.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959035850</udiDi>
    <basicUdiDi>B-00606959035850</basicUdiDi>
    <tradeName>S/M Pico Traditional Nasal Mask w/HGR</tradeName>
    <deviceName>S/M Pico Traditional Nasal Mask w/HGR</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>1104915</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:20:00.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959031104</udiDi>
    <basicUdiDi>B-00606959031104</basicUdiDi>
    <tradeName>S DreamWear Under Nose Mask, L Frame w/o Headgr, Global</tradeName>
    <deviceName>S DreamWear Under Nose Mask, L Frame w/o 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>1116715</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:59.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959031067</udiDi>
    <basicUdiDi>B-00606959031067</basicUdiDi>
    <tradeName>S DreamWear Under Nose Mask, S Frame w/o Headgear, Global</tradeName>
    <deviceName>S DreamWear Under Nose Mask, S Frame w/o 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>1116710</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:19:59.019Z</lastUpdated>
  </row>
</eudamedExport>