<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>30606959041739</udiDi>
    <basicUdiDi>B-30606959041739</basicUdiDi>
    <tradeName>PN841, INTL, Child Med, Leak 3, 5 Pack</tradeName>
    <deviceName>PN841, INTL, Child Med, Leak 3, 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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1130580</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:21.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959041722</udiDi>
    <basicUdiDi>B-30606959041722</basicUdiDi>
    <tradeName>PN841, INTL, Child Small, Leak 3, 5 Pack</tradeName>
    <deviceName>PN841, INTL, Child Small, Leak 3, 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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1130579</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:20.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012470</udiDi>
    <basicUdiDi>B-30606959012470</basicUdiDi>
    <tradeName>ACC, PerforMax Ped EE Leak 1 Elbow, 5 Pack</tradeName>
    <deviceName>ACC, PerforMax Ped EE Leak 1 Elbow, 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>1100688</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:07.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012425</udiDi>
    <basicUdiDi>B-30606959012425</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>1100395</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:03.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012418</udiDi>
    <basicUdiDi>B-30606959012418</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>1100394</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:01.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012401</udiDi>
    <basicUdiDi>B-30606959012401</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>1100393</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:00.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012128</udiDi>
    <basicUdiDi>B-30606959012128</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>1072632</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:00.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012111</udiDi>
    <basicUdiDi>B-30606959012111</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>1072631</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:56.123Z</lastUpdated>
  </row>
  <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>
</eudamedExport>