<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959042933</udiDi>
    <basicUdiDi>B-00606959042933</basicUdiDi>
    <tradeName>Trilogy100 Ventilator, Bluetooth, Italy</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>IT1054096B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:09:02.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959042926</udiDi>
    <basicUdiDi>B-00606959042926</basicUdiDi>
    <tradeName>Trilogy 200 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IT1032800B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:09:01.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959042551</udiDi>
    <basicUdiDi>B-00606959042551</basicUdiDi>
    <tradeName>Philips Basic Kit, PerformaTrak SE, INTL</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>Z12062402</emdnCode>
    <emdnDescription>POSITIONAL BIOFEEDBACK SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1074050</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:09:00.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959042353</udiDi>
    <basicUdiDi>B-00606959042353</basicUdiDi>
    <tradeName>BiPap Vision Disposable Circuit, Single</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>R02010402</emdnCode>
    <emdnDescription>NIV CIRCUITS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>582072</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:58.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959042315</udiDi>
    <basicUdiDi>B-00606959042315</basicUdiDi>
    <tradeName>FEP Circuit S/A w/Filter – INTL</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>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1065834</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:54.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959042100</udiDi>
    <basicUdiDi>B-00606959042100</basicUdiDi>
    <tradeName>Actiwatch Spectrum Communication Dock</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1046978</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:53.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959042056</udiDi>
    <basicUdiDi>B-00606959042056</basicUdiDi>
    <tradeName>Actiwatch 2 Communication Dock</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>Z12062599</emdnCode>
    <emdnDescription>KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1046977</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:53.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959041530</udiDi>
    <basicUdiDi>B-00606959041530</basicUdiDi>
    <tradeName>CoughAssist, Mouthpiece</tradeName>
    <deviceName>CoughAssist Class IIa Accessories</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>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1044821</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:52.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959040502</udiDi>
    <basicUdiDi>B-00606959040502</basicUdiDi>
    <tradeName>DreamStation Micro-Flex PR12 Tube Starter Pack</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>1128071</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:48.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959040366</udiDi>
    <basicUdiDi>B-00606959040366</basicUdiDi>
    <tradeName>Actiware Clinical Trial Software, English - 6</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>1103609</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:47.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959040205</udiDi>
    <basicUdiDi>B-00606959040205</basicUdiDi>
    <tradeName>AIR FLOW,CANNULA SAMPLE PACK</tradeName>
    <deviceName>ProTech Air Flow Sensor</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1258</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:46.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959039889</udiDi>
    <basicUdiDi>B-00606959039889</basicUdiDi>
    <tradeName>Actiware Software Pkg., Addl License BOM</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>1083204</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:45.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959039872</udiDi>
    <basicUdiDi>B-00606959039872</basicUdiDi>
    <tradeName>Actiware Software Web Download - 6</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>1104776</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:41.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959039834</udiDi>
    <basicUdiDi>B-00606959039834</basicUdiDi>
    <tradeName>Alice NightOne Non-Wireless, Warranty, INTL</tradeName>
    <deviceName>Alice NightOne System</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>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1114804</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:40.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959039827</udiDi>
    <basicUdiDi>B-00606959039827</basicUdiDi>
    <tradeName>Alice NightOne Wireless, Warranty ,INTL</tradeName>
    <deviceName>Alice NightOne System</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>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1114802</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:39.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959039803</udiDi>
    <basicUdiDi>B-00606959039803</basicUdiDi>
    <tradeName>Alice NightOne, Non-Wireless Device, INTL</tradeName>
    <deviceName>Alice NightOne System</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>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1114803</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:38.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959039797</udiDi>
    <basicUdiDi>B-00606959039797</basicUdiDi>
    <tradeName>Alice NightOne Wireless Device, INTL</tradeName>
    <deviceName>Alice NightOne System</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>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1114801</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:34.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959039728</udiDi>
    <basicUdiDi>B-00606959039728</basicUdiDi>
    <tradeName>Alice NightOne, Nonin SpO2 Cable</tradeName>
    <deviceName>Alice NightOne System</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1119823</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:33.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959037427</udiDi>
    <basicUdiDi>B-00606959037427</basicUdiDi>
    <tradeName>CoughAssist 70 Series Circuit, Trach, 9ft</tradeName>
    <deviceName>CoughAssist Class IIa Accessories</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>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1098409</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:32.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959039025</udiDi>
    <basicUdiDi>B-00606959039025</basicUdiDi>
    <tradeName>Alice PDx Core System without Sensors, INTL</tradeName>
    <deviceName>Alice PDx System</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>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1058370</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:32.293Z</lastUpdated>
  </row>
</eudamedExport>