<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959026810</udiDi>
    <basicUdiDi>B-00606959026810</basicUdiDi>
    <tradeName>DreamWear Gel Pillows Mask, M, M Frame w/o Headgr, Global</tradeName>
    <deviceName>DreamWear Gel Pillows</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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1124987</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:04:10.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026803</udiDi>
    <basicUdiDi>B-00606959026803</basicUdiDi>
    <tradeName>DreamWear Gel Pillows Mask, S, M Frame w/o Headgear, Global</tradeName>
    <deviceName>DreamWear Gel Pillows</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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1124986</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:04:08.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026797</udiDi>
    <basicUdiDi>B-00606959026797</basicUdiDi>
    <tradeName>DreamWear Gel Pillows Mask, M Frame w/o Headgear, Global</tradeName>
    <deviceName>DreamWear Gel Pillows</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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1124985</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:04:06.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026780</udiDi>
    <basicUdiDi>B-00606959026780</basicUdiDi>
    <tradeName>DreamWear Gel Pillows Mask, Medium Frame w/Hgr, Global</tradeName>
    <deviceName>DreamWear Gel Pillows</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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1124984</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:04:04.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026513</udiDi>
    <basicUdiDi>B-00606959026513</basicUdiDi>
    <tradeName>Garbin Plus Ventilator, Bluetooth, INTL</tradeName>
    <deviceName>Trilogy 200</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1040002B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:04:03.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026506</udiDi>
    <basicUdiDi>B-00606959026506</basicUdiDi>
    <tradeName>Trilogy 200 Ventilator Germany Bluetooth</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1032802B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:04:02.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026490</udiDi>
    <basicUdiDi>B-00606959026490</basicUdiDi>
    <tradeName>Garbin Ventilator, Bluetooth, DE</tradeName>
    <deviceName>Trilogy 100, Trilogy EC</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1040001B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:59.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026483</udiDi>
    <basicUdiDi>B-00606959026483</basicUdiDi>
    <tradeName>Garbin Ventilator — Bluetooth</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1058180B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:58.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026476</udiDi>
    <basicUdiDi>B-00606959026476</basicUdiDi>
    <tradeName>Trilogy100 Ventilator, Bluetooth, Germany</tradeName>
    <deviceName>Trilogy 100, Trilogy EC</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1054097B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:57.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026469</udiDi>
    <basicUdiDi>B-00606959026469</basicUdiDi>
    <tradeName>Trilogy 100 Ventilator, INTL — Bluetooth</tradeName>
    <deviceName></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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1054096B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:55.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026360</udiDi>
    <basicUdiDi>B-00606959026360</basicUdiDi>
    <tradeName>Trilogy 200 Ventilator, INTL-Bluetooth</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1032800B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:53.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026339</udiDi>
    <basicUdiDi>B-00606959026339</basicUdiDi>
    <tradeName>FitLife Mask, Extra Large, with Headgear, International</tradeName>
    <deviceName>FitLife Family</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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1089994</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:51.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026292</udiDi>
    <basicUdiDi>B-00606959026292</basicUdiDi>
    <tradeName>Trilogy100 Ventilator, Germany-Recert</tradeName>
    <deviceName>Trilogy 100, Trilogy EC</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U1054097</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:51.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026285</udiDi>
    <basicUdiDi>B-00606959026285</basicUdiDi>
    <tradeName>Trilogy100 Ventilator, Germany-Rental</tradeName>
    <deviceName>Trilogy 100, Trilogy EC</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R1054097</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:49.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026278</udiDi>
    <basicUdiDi>B-00606959026278</basicUdiDi>
    <tradeName>Trilogy100 Ventilator, Intl-Recert</tradeName>
    <deviceName>Trilogy 100, Trilogy EC</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U1054096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:47.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026261</udiDi>
    <basicUdiDi>B-00606959026261</basicUdiDi>
    <tradeName>Trilogy100 Ventilator, Intl-Rental</tradeName>
    <deviceName>Trilogy 100, Trilogy EC</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R1054096</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:45.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959025233</udiDi>
    <basicUdiDi>B-00606959025233</basicUdiDi>
    <tradeName>S AMARA GEL MASK SE W/RS FRAME AND RS HGR INT</tradeName>
    <deviceName></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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1090431</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:44.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959023154</udiDi>
    <basicUdiDi>B-00606959023154</basicUdiDi>
    <tradeName>Small Comfort Classic with Headgear - Iberia</tradeName>
    <deviceName></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>Artık piyasada değil</deviceStatus>
    <reference>1007967</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:43.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959023161</udiDi>
    <basicUdiDi>B-00606959023161</basicUdiDi>
    <tradeName>Medium Comfort Classic with Headgear - Iberia</tradeName>
    <deviceName></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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1007968</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:40.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959023062</udiDi>
    <basicUdiDi>B-00606959023062</basicUdiDi>
    <tradeName>FitLife Mask with Headgear, w/SE, Large, INTL</tradeName>
    <deviceName>FitLife Family</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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1061712</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:39.107Z</lastUpdated>
  </row>
</eudamedExport>