<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959011991</udiDi>
    <basicUdiDi>B-00606959011991</basicUdiDi>
    <tradeName>Performax Mask With Se, Single Patient Use, Xlarge</tradeName>
    <deviceName>Performax Mask With Se, Single Patient Use, Xlarge</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>1080414</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:56.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959011960</udiDi>
    <basicUdiDi>B-00606959011960</basicUdiDi>
    <tradeName>XL Performax Mpu Intl W/Ee Leak 2,Plus 4 Headgear</tradeName>
    <deviceName>XL Performax Mpu Intl W/Ee Leak 2,Plus 4 Headgear</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>1080421</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:51.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959011953</udiDi>
    <basicUdiDi>B-00606959011953</basicUdiDi>
    <tradeName>XL Performax Mpu W/Ee Leak 2 &amp; Se, Plus 4 Headgear</tradeName>
    <deviceName>XL Performax Mpu W/Ee Leak 2 &amp; Se, Plus 4 Headgear</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>1080420</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:50.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959011984</udiDi>
    <basicUdiDi>B-00606959011984</basicUdiDi>
    <tradeName>Performax Mask With Ee, Single Patient Use, Xlarge</tradeName>
    <deviceName>Performax Mask With Ee, Single Patient Use, Xlarge</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>1080413</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:50.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959011977</udiDi>
    <basicUdiDi>B-00606959011977</basicUdiDi>
    <tradeName>Xl Performax Mpu Intl W/Se, Plus 4 Headgear</tradeName>
    <deviceName>Xl Performax Mpu Intl W/Se, Plus 4 Headgear</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>1080422</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:49.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959011915</udiDi>
    <basicUdiDi>B-00606959011915</basicUdiDi>
    <tradeName>L Performax Mpu Intl W/Se, Plus 4 Headgear</tradeName>
    <deviceName>L Performax Mpu Intl W/Se, Plus 4 Headgear</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>1052569</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:31.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959011908</udiDi>
    <basicUdiDi>B-00606959011908</basicUdiDi>
    <tradeName>S Performax Mpu Intl W/Se, Plus 4 Headgear</tradeName>
    <deviceName>S Performax Mpu Intl W/Se, Plus 4 Headgear</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>1052568</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:30.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959011892</udiDi>
    <basicUdiDi>B-00606959011892</basicUdiDi>
    <tradeName>L Performax Mpu Intl W/Ee Leak 2, Plus 4 Headgear</tradeName>
    <deviceName>L Performax Mpu Intl W/Ee Leak 2, Plus 4 Headgear</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>1052556</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:29.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959011885</udiDi>
    <basicUdiDi>B-00606959011885</basicUdiDi>
    <tradeName>S Performax Mpu Intl W/Ee Leak 2, Plus 4 Headgear</tradeName>
    <deviceName>S Performax Mpu Intl W/Ee Leak 2, Plus 4 Headgear</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>1052555</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:29.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009288</udiDi>
    <basicUdiDi>B-00606959009288</basicUdiDi>
    <tradeName>A m a r a View Mask w/Hgr FitPack</tradeName>
    <deviceName>A m a r a View Mask w/Hgr FitPack</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>1090670</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:25.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009271</udiDi>
    <basicUdiDi>B-00606959009271</basicUdiDi>
    <tradeName>L Amara View Mask w/Hgr, Intl</tradeName>
    <deviceName>L Amara View 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>1090664</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:24.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009257</udiDi>
    <basicUdiDi>B-00606959009257</basicUdiDi>
    <tradeName>S Amara View Mask w/Hgr, Intl</tradeName>
    <deviceName>S Amara View 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>1090662</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:23.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009158</udiDi>
    <basicUdiDi>B-00606959009158</basicUdiDi>
    <tradeName>L Amara View Mask w/Hgr</tradeName>
    <deviceName>L Amara View 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>1090604</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:22.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009141</udiDi>
    <basicUdiDi>B-00606959009141</basicUdiDi>
    <tradeName>M Amara View Mask w/Hgr</tradeName>
    <deviceName>M Amara View 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>1090603</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:18.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009134</udiDi>
    <basicUdiDi>B-00606959009134</basicUdiDi>
    <tradeName>S Amara View Mask w/Hgr</tradeName>
    <deviceName>S Amara View 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>1090602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:17.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959008298</udiDi>
    <basicUdiDi>B-00606959008298</basicUdiDi>
    <tradeName>Standard Elbow, Nebulizing Elbow Kit</tradeName>
    <deviceName>Standard Elbow, Nebulizing Elbow Kit</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>1119038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:17.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959008137</udiDi>
    <basicUdiDi>B-00606959008137</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, Large, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, 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>1119037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:16.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959008120</udiDi>
    <basicUdiDi>B-00606959008120</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, Med, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, Med, 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>1119036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:11.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959008113</udiDi>
    <basicUdiDi>B-00606959008113</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, Small, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, 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>1119035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:10.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959008106</udiDi>
    <basicUdiDi>B-00606959008106</basicUdiDi>
    <tradeName>AF531Mask EE, Leak 1, Circuit, Neb Elbow, CapStrap, L, SU</tradeName>
    <deviceName>AF531Mask EE, Leak 1, Circuit, Neb Elbow, CapStrap, L, 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>1119034</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:18:09.929Z</lastUpdated>
  </row>
</eudamedExport>