<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959007758</udiDi>
    <basicUdiDi>B-00606959007758</basicUdiDi>
    <tradeName>PerforMax Mask w/SE, Extra Small, Single Use</tradeName>
    <deviceName>PerforMax Mask w/SE, Extra 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>1119026</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:49.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007741</udiDi>
    <basicUdiDi>B-00606959007741</basicUdiDi>
    <tradeName>PerforMax Mask with EE, Leak 2, XXSmall, Single Use</tradeName>
    <deviceName>PerforMax Mask with EE, Leak 2, XXSmall, 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>1119025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:45.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007734</udiDi>
    <basicUdiDi>B-00606959007734</basicUdiDi>
    <tradeName>PerforMax Mask with EE, Leak 2, XSmall, Single Use</tradeName>
    <deviceName>PerforMax Mask with EE, Leak 2, XSmall, 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>1119024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:44.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007727</udiDi>
    <basicUdiDi>B-00606959007727</basicUdiDi>
    <tradeName>XL Performax Su W/Se — Single</tradeName>
    <deviceName>XL Performax Su W/Se — Single</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>1080517</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:43.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007710</udiDi>
    <basicUdiDi>B-00606959007710</basicUdiDi>
    <tradeName>L Performax Su W/Se — Single</tradeName>
    <deviceName>L Performax Su W/Se — Single</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>1061622</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:42.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007703</udiDi>
    <basicUdiDi>B-00606959007703</basicUdiDi>
    <tradeName>S Performax Su W/Se — Single</tradeName>
    <deviceName>S Performax Su W/Se — Single</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>1061621</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:38.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007697</udiDi>
    <basicUdiDi>B-00606959007697</basicUdiDi>
    <tradeName>XL Performax Su W/Ee Leak 2 — Single</tradeName>
    <deviceName>XL Performax Su W/Ee Leak 2 — Single</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>1080426</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:37.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007505</udiDi>
    <basicUdiDi>B-00606959007505</basicUdiDi>
    <tradeName>AF531Mask EE, Leak 1, Neb Elbow, 4 PT Headgr, Large, SU</tradeName>
    <deviceName>AF531Mask EE, Leak 1, Neb Elbow, 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>1119023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:36.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007499</udiDi>
    <basicUdiDi>B-00606959007499</basicUdiDi>
    <tradeName>AF531Mask EE, Leak 1, Neb Elbow, w/4 PT Headgr, Med, SU</tradeName>
    <deviceName>AF531Mask EE, Leak 1, Neb Elbow, w/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>1119022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:35.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007482</udiDi>
    <basicUdiDi>B-00606959007482</basicUdiDi>
    <tradeName>AF531Mask EE, Leak 1, Neb Elbow, w/4 PT Headgr, Sm, SU</tradeName>
    <deviceName>AF531Mask EE, Leak 1, Neb Elbow, w/4 PT Headgr, 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>1119021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:31.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007383</udiDi>
    <basicUdiDi>B-00606959007383</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>1119020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:30.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007376</udiDi>
    <basicUdiDi>B-00606959007376</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>1119019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:29.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007369</udiDi>
    <basicUdiDi>B-00606959007369</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 2, with W/CapStrap, Small, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 2, with 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>1119018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:29.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007321</udiDi>
    <basicUdiDi>B-00606959007321</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>1119014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:25.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007314</udiDi>
    <basicUdiDi>B-00606959007314</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>1119013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:24.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959007307</udiDi>
    <basicUdiDi>B-00606959007307</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>1119012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:23.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959004603</udiDi>
    <basicUdiDi>B-00606959004603</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>1119011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:22.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959004597</udiDi>
    <basicUdiDi>B-00606959004597</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>1119010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:17.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959004580</udiDi>
    <basicUdiDi>B-00606959004580</basicUdiDi>
    <tradeName>AF531 Mask EE, LEAK 1, with CapStrap, Small, Single Use</tradeName>
    <deviceName>AF531 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>1119009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:17.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959004573</udiDi>
    <basicUdiDi>B-00606959004573</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>1119008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:17:16.280Z</lastUpdated>
  </row>
</eudamedExport>