<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>30606959000859</udiDi>
    <basicUdiDi>B-30606959000859</basicUdiDi>
    <tradeName>S Performax Su Intl W/Ee Leak 2 -10 Pack</tradeName>
    <deviceName>S 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>1052535</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:45:11.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062511</udiDi>
    <basicUdiDi>B-00606959062511</basicUdiDi>
    <tradeName>Small/Medium, Large, Extra Large Pico Fitpack, with Headgear, Malaysia</tradeName>
    <deviceName>Small/Medium, Large, Extra Large Pico Fitpack, with Headgear, Malaysia</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>1104940MY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:32.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062504</udiDi>
    <basicUdiDi>B-00606959062504</basicUdiDi>
    <tradeName>Extra Large Pico Nasal Mask with Headgear Malaysia</tradeName>
    <deviceName>Extra Large Pico Nasal Mask with Headgear Malaysia</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>1104923MY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:31.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062498</udiDi>
    <basicUdiDi>B-00606959062498</basicUdiDi>
    <tradeName>Large Pico Nasal Mask with Headgear Malaysia</tradeName>
    <deviceName>Large Pico Nasal Mask with Headgear Malaysia</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>1104922MY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:27.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062481</udiDi>
    <basicUdiDi>B-00606959062481</basicUdiDi>
    <tradeName>Small/Medium Pico Nasal Mask with Headgear Malaysia</tradeName>
    <deviceName>Small/Medium Pico Nasal Mask with Headgear Malaysia</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>1104921MY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:26.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062443</udiDi>
    <basicUdiDi>B-00606959062443</basicUdiDi>
    <tradeName>Dreamwear Under the Nose/Silicone Pillows Frame Kit Large</tradeName>
    <deviceName>Dreamwear Under the Nose/Silicone Pillows Frame Kit Large</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>1148934</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:25.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062436</udiDi>
    <basicUdiDi>B-00606959062436</basicUdiDi>
    <tradeName>Dreamwear Under the Nose/Silicone Pillows Frame Kit Medium</tradeName>
    <deviceName>Dreamwear Under the Nose/Silicone Pillows Frame Kit Medium</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>1148933</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:25.157Z</lastUpdated>
  </row>
</eudamedExport>