<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>30606959008299</udiDi>
    <basicUdiDi>B-30606959008299</basicUdiDi>
    <tradeName>SE Nebulizing Elbow Kit, 5 Pack</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>1076754</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:14.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007858</udiDi>
    <basicUdiDi>B-30606959007858</basicUdiDi>
    <tradeName>Bronchoscopy Elbow (BE) RP Kit, 5 Pack</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>Piyasada</deviceStatus>
    <reference>1072652</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:13.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007834</udiDi>
    <basicUdiDi>B-30606959007834</basicUdiDi>
    <tradeName>EE Nebulizing Elbow Kit, 5 Pack</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>Piyasada</deviceStatus>
    <reference>1072650</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:09.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007353</udiDi>
    <basicUdiDi>B-30606959007353</basicUdiDi>
    <tradeName>L AF531 SE NE W/CapStrap, SU, 10 Pack</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>1100438</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:08.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007346</udiDi>
    <basicUdiDi>B-30606959007346</basicUdiDi>
    <tradeName>M AF531 SE NE W/CapStrap, SU, 10 Pack</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>1100397</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:08.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959007339</udiDi>
    <basicUdiDi>B-30606959007339</basicUdiDi>
    <tradeName>S AF531 SE NE W/CapStrap, SU, 10 Pack</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>1100396</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:07.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959000743</udiDi>
    <basicUdiDi>B-30606959000743</basicUdiDi>
    <tradeName>CONTOUR DELUXE SU W/HEADGEAR, M/L, 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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1016695</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:03.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959000736</udiDi>
    <basicUdiDi>B-30606959000736</basicUdiDi>
    <tradeName>CONTOUR DELUXE SU W/HEADGEAR, S, INT – 5 PACK</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>1016697</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:02.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959429567</udiDi>
    <basicUdiDi>B-00606959429567</basicUdiDi>
    <tradeName>Trilogy 200</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>1032802</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:18:53.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959429536</udiDi>
    <basicUdiDi>B-00606959429536</basicUdiDi>
    <tradeName>Trilogy 100 Ventilator, Germany</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>1054097</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:18:52.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959429512</udiDi>
    <basicUdiDi>B-00606959429512</basicUdiDi>
    <tradeName>Trilogy 100 Ventilator, Italy - BT</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>IT1054096B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:18:48.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959429376</udiDi>
    <basicUdiDi>B-00606959429376</basicUdiDi>
    <tradeName>Trilogy 200 Ventilator, AERIS 200-BT</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>1125564B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:18:47.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959429352</udiDi>
    <basicUdiDi>B-00606959429352</basicUdiDi>
    <tradeName>Garbin Ventilator, International</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>1040002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:18:46.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959429338</udiDi>
    <basicUdiDi>B-00606959429338</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>2026-07-04T14:18:45.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959429284</udiDi>
    <basicUdiDi>B-00606959429284</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>2026-07-04T14:18:41.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959429260</udiDi>
    <basicUdiDi>B-00606959429260</basicUdiDi>
    <tradeName>Trilogy 200 Ventilator, International</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>1032800</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:18:40.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959429253</udiDi>
    <basicUdiDi>B-00606959429253</basicUdiDi>
    <tradeName>Trilogy100 Ventilator, International</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>1054096</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:18:39.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959429246</udiDi>
    <basicUdiDi>B-00606959429246</basicUdiDi>
    <tradeName>Trilogy 100 Ventilator, INTL — Bluetooth</tradeName>
    <deviceName>Trilogy 100</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>1054096B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:18:38.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424739</udiDi>
    <basicUdiDi>B-00606959424739</basicUdiDi>
    <tradeName>DreamStation Auto CPAP, INTL</tradeName>
    <deviceName>DreamStation</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>Z1203010502</emdnCode>
    <emdnDescription>ADULT PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX500S15</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:18:34.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959423725</udiDi>
    <basicUdiDi>B-00606959423725</basicUdiDi>
    <tradeName>AW CT Insmed INS 416 Pkg Site</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</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>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1149189</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:18:33.861Z</lastUpdated>
  </row>
</eudamedExport>