<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>30606959012104</udiDi>
    <basicUdiDi>B-30606959012104</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>1072630</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:55.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012098</udiDi>
    <basicUdiDi>B-30606959012098</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>1072626</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:54.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012081</udiDi>
    <basicUdiDi>B-30606959012081</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>1072625</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:53.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012074</udiDi>
    <basicUdiDi>B-30606959012074</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>1072624</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:49.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959011992</udiDi>
    <basicUdiDi>B-30606959011992</basicUdiDi>
    <tradeName>XL Performax Su W/Se — 5 Pack</tradeName>
    <deviceName>XL Performax Su W/Se — 5 Pack</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>1080425</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:48.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959011985</udiDi>
    <basicUdiDi>B-30606959011985</basicUdiDi>
    <tradeName>XL Performax Su W/Ee Leak 2—5 Pack</tradeName>
    <deviceName>XL Performax Su W/Ee Leak 2—5 Pack</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>1080424</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:48.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959008138</udiDi>
    <basicUdiDi>B-30606959008138</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>1072641</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:47.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959008121</udiDi>
    <basicUdiDi>B-30606959008121</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>1072640</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:42.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959008114</udiDi>
    <basicUdiDi>B-30606959008114</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>1072639</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:41.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959008107</udiDi>
    <basicUdiDi>B-30606959008107</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>1072644</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:40.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959008091</udiDi>
    <basicUdiDi>B-30606959008091</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 1, Circuit, Neb Elbow, CapStrap, Med, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 1, Circuit, Neb Elbow, CapStrap, 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>1072643</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:40.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959008084</udiDi>
    <basicUdiDi>B-30606959008084</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 1, Circuit, Neb Elbow, CapStrap, Sm, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 1, Circuit, Neb Elbow, CapStrap, Sm, 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>1072642</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:36.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007766</udiDi>
    <basicUdiDi>B-30606959007766</basicUdiDi>
    <tradeName>XXS PerforMax SE, SU, 5 Pack</tradeName>
    <deviceName>XXS PerforMax SE, SU, 5 Pack</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>1083150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:35.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007759</udiDi>
    <basicUdiDi>B-30606959007759</basicUdiDi>
    <tradeName>XS PerforMax SE, SU, 5 Pack</tradeName>
    <deviceName>XS PerforMax SE, SU, 5 Pack</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>1083149</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:34.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007742</udiDi>
    <basicUdiDi>B-30606959007742</basicUdiDi>
    <tradeName>XXS PerforMax EE Leak 2, SU, 5 Pack</tradeName>
    <deviceName>XXS PerforMax EE Leak 2, SU, 5 Pack</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>1083148</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:33.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007735</udiDi>
    <basicUdiDi>B-30606959007735</basicUdiDi>
    <tradeName>XS PerforMax EE Leak 2, SU, 5 Pack</tradeName>
    <deviceName>XS PerforMax EE Leak 2, SU, 5 Pack</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>1083147</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:29.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007506</udiDi>
    <basicUdiDi>B-30606959007506</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 1, Neb Elbow, 4 PT Hdgr, Large, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 1, Neb Elbow, 4 PT Hdgr, 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>1072635</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:28.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007490</udiDi>
    <basicUdiDi>B-30606959007490</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 1, Neb Elbow, w/4 PT Hdgr, Med, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 1, Neb Elbow, w/4 PT Hdgr, 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>1072634</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:28.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007483</udiDi>
    <basicUdiDi>B-30606959007483</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 1, Neb Elbow, w/4 PT Hdgr, Small, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 1, Neb Elbow, w/4 PT Hdgr, 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>1072633</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:27.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007384</udiDi>
    <basicUdiDi>B-30606959007384</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 2, w/CapStrap, Large, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 2, w/CapStrap, 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>1100392</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:22.530Z</lastUpdated>
  </row>
</eudamedExport>