<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <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>
  <row>
    <udiDi>30606959007377</udiDi>
    <basicUdiDi>B-30606959007377</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 2, w/CapStrap, Medium, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 2, w/CapStrap, 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>1100391</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:21.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007360</udiDi>
    <basicUdiDi>B-30606959007360</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 2, W/CapStrap, Small, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 2, W/CapStrap, 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>1100390</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:20.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007322</udiDi>
    <basicUdiDi>B-30606959007322</basicUdiDi>
    <tradeName>A531 Mask EE, LEAK1, Nebulizing Elbow, W/CapStrap, Large, SU</tradeName>
    <deviceName>A531 Mask EE, LEAK1, Nebulizing Elbow, 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>1072638</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:20.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007315</udiDi>
    <basicUdiDi>B-30606959007315</basicUdiDi>
    <tradeName>A531 Mask EE, LEAK1, Neb Elbow, w/CapStrap, Med, SU</tradeName>
    <deviceName>A531 Mask EE, LEAK1, Neb Elbow, w/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>1072637</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:16.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007308</udiDi>
    <basicUdiDi>B-30606959007308</basicUdiDi>
    <tradeName>A531 Mask EE, LEAK1, Nebulizing Elbow, w/CapStrap, Small, SU</tradeName>
    <deviceName>A531 Mask EE, LEAK1, Nebulizing Elbow, w/CapStrap, 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>1072636</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:15.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959004604</udiDi>
    <basicUdiDi>B-30606959004604</basicUdiDi>
    <tradeName>AF531 Mask EE, LEAK 1, with CapStrap, Large, Single Use</tradeName>
    <deviceName>AF531 Mask EE, LEAK 1, with 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>1072629</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:14.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959004598</udiDi>
    <basicUdiDi>B-30606959004598</basicUdiDi>
    <tradeName>AF531 Mask EE, LEAK 1, with CapStrap, Medium, Single Use</tradeName>
    <deviceName>AF531 Mask EE, LEAK 1, with 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>1072628</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:13.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959004581</udiDi>
    <basicUdiDi>B-30606959004581</basicUdiDi>
    <tradeName>AF5EE31 Mask EE, LEAK 1, with CapStrap, Small, Single Use</tradeName>
    <deviceName>AF5EE31 Mask EE, LEAK 1, with 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>1072627</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:45:33.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959004574</udiDi>
    <basicUdiDi>B-30606959004574</basicUdiDi>
    <tradeName>AF531 Mask EE, LEAK 1, with 4 PT Headgear, Large, Single Use</tradeName>
    <deviceName>AF531 Mask EE, LEAK 1, with 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>1072623</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:45:32.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959004567</udiDi>
    <basicUdiDi>B-30606959004567</basicUdiDi>
    <tradeName>AF531 Mask EE, LEAK 1, with 4 PT Headgr, Medium, Single Use</tradeName>
    <deviceName>AF531 Mask EE, LEAK 1, with 4 PT Headgr, 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>1072622</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:45:31.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959004550</udiDi>
    <basicUdiDi>B-30606959004550</basicUdiDi>
    <tradeName>AF531 Mask EE, LEAK 1, with 4 PT Headgear, Small, Single Use</tradeName>
    <deviceName>AF531 Mask EE, LEAK 1, with 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>1072621</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:45:27.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959000880</udiDi>
    <basicUdiDi>B-30606959000880</basicUdiDi>
    <tradeName>L Performax Su Intl W/Se —10 Pack</tradeName>
    <deviceName>L Performax Su Intl W/Se —10 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>1052548</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:45:13.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959000866</udiDi>
    <basicUdiDi>B-30606959000866</basicUdiDi>
    <tradeName>L Performax Su Intl W/Ee Leak 2 -10 Pack</tradeName>
    <deviceName>L Performax Su Intl W/Ee Leak 2 -10 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>1052536</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:45:12.323Z</lastUpdated>
  </row>
</eudamedExport>