<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959050815</udiDi>
    <basicUdiDi>B-00606959050815</basicUdiDi>
    <tradeName>External Flow Sensor w/Cable, Adult/Ped</tradeName>
    <deviceName>External Flow Sensor w/Cable, Adult/Ped</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>Piyasada</deviceStatus>
    <reference>1132106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:19:00.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959049628</udiDi>
    <basicUdiDi>B-00606959049628</basicUdiDi>
    <tradeName>(10) Circuit,Disp,22mm,Non-Htd,Dual Limb</tradeName>
    <deviceName>(10) Circuit,Disp,22mm,Non-Htd,Dual Limb</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>Piyasada</deviceStatus>
    <reference>1127306</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:18:57.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959045101</udiDi>
    <basicUdiDi>B-00606959045101</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T30 AAM w/Humidifier, DE</tradeName>
    <deviceName>DreamStation BiPAP S/T30 AAM w/Humidifier, DE</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>Piyasada</deviceStatus>
    <reference>DEX1030H13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:18:47.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959044999</udiDi>
    <basicUdiDi>B-00606959044999</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T30 AAM, DE</tradeName>
    <deviceName>DreamStation BiPAP S/T30 AAM, DE</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>Piyasada</deviceStatus>
    <reference>DEX1030S13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:18:46.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959044975</udiDi>
    <basicUdiDi>B-00606959044975</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T30 AAM, no Bluetooth, ZA</tradeName>
    <deviceName>DreamStation BiPAP S/T30 AAM, no Bluetooth, ZA</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>Piyasada</deviceStatus>
    <reference>ZAX1030S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:18:45.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959044708</udiDi>
    <basicUdiDi>B-00606959044708</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AAM, no Bluetooth, ZA</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AAM, no Bluetooth, ZA</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>Piyasada</deviceStatus>
    <reference>ZAX1130S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:11:13.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959044685</udiDi>
    <basicUdiDi>B-00606959044685</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AAM w/Hum,no Bluetooth, ZA</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AAM w/Hum,no Bluetooth, ZA</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>Piyasada</deviceStatus>
    <reference>ZAX1130H19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:11:13.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959042377</udiDi>
    <basicUdiDi>B-00606959042377</basicUdiDi>
    <tradeName>Circuit Filter DEP w/FEP Filter Single, Intl</tradeName>
    <deviceName>Circuit Filter DEP w/FEP Filter Single, Intl</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>Piyasada</deviceStatus>
    <reference>1073949</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:11:01.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959043022</udiDi>
    <basicUdiDi>B-00606959043022</basicUdiDi>
    <tradeName>Trilogy, Mouthpiece Ventilation Disposable Circuit</tradeName>
    <deviceName>Trilogy, Mouthpiece Ventilation Disposable Circuit</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>Piyasada</deviceStatus>
    <reference>1102869</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:59.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959042339</udiDi>
    <basicUdiDi>B-00606959042339</basicUdiDi>
    <tradeName>FEP Circuit S/A W/O Filters</tradeName>
    <deviceName>FEP Circuit S/A W/O Filters</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>Piyasada</deviceStatus>
    <reference>1069211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:42.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959042063</udiDi>
    <basicUdiDi>B-00606959042063</basicUdiDi>
    <tradeName>MPV Support System Kit</tradeName>
    <deviceName>MPV Support System Kit</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>Piyasada</deviceStatus>
    <reference>1102862</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:41.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026162</udiDi>
    <basicUdiDi>B-00606959026162</basicUdiDi>
    <tradeName>Trilogy Passive Exhalation Circuit, Pediatric</tradeName>
    <deviceName>Trilogy Passive Exhalation Circuit, Pediatric</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>Piyasada</deviceStatus>
    <reference>1052127</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:15.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026155</udiDi>
    <basicUdiDi>B-00606959026155</basicUdiDi>
    <tradeName>Trilogy Passive Exhalation Circuit, Adult</tradeName>
    <deviceName>Trilogy Passive Exhalation Circuit, Adult</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>Piyasada</deviceStatus>
    <reference>1052066</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:14.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026148</udiDi>
    <basicUdiDi>B-00606959026148</basicUdiDi>
    <tradeName>Trilogy Active with PAP Exhalation Circuit, Pediatric</tradeName>
    <deviceName>Trilogy Active with PAP Exhalation Circuit, Pediatric</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>Piyasada</deviceStatus>
    <reference>1052065</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:10.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026131</udiDi>
    <basicUdiDi>B-00606959026131</basicUdiDi>
    <tradeName>Trilogy Active with PAP Exhalation Circuit, Adult</tradeName>
    <deviceName>Trilogy Active with PAP Exhalation Circuit, Adult</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>Piyasada</deviceStatus>
    <reference>1052064</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:09.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959005297</udiDi>
    <basicUdiDi>B-00606959005297</basicUdiDi>
    <tradeName>Active Exhalation Device with PAP</tradeName>
    <deviceName>Active Exhalation Device with PAP</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>Piyasada</deviceStatus>
    <reference>1053716</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:09:17.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959005228</udiDi>
    <basicUdiDi>B-00606959005228</basicUdiDi>
    <tradeName>Trilogy Active Flow Exhalation Circuit, Pediatric</tradeName>
    <deviceName>Trilogy Active Flow Exhalation Circuit, Pediatric</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>Piyasada</deviceStatus>
    <reference>1068838</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:09:16.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033737268407</udiDi>
    <basicUdiDi>80337372684QM</basicUdiDi>
    <tradeName>CAP 700</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siare Enginnering International Group S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025581</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>980700</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:47:12.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959042323</udiDi>
    <basicUdiDi>B-30606959042323</basicUdiDi>
    <tradeName>Single Use Filtered Exhalation Port Circuit</tradeName>
    <deviceName>CKT FILTER DEP W/FEP 10PK INTL</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>Piyasada</deviceStatus>
    <reference>1065836</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:21.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698863811677</udiDi>
    <basicUdiDi>B-08698863811677</basicUdiDi>
    <tradeName>BiNefes</tradeName>
    <deviceName>Ventilator</deviceName>
    <manufacturerName>Foras Bilgisayar Elektronik Medikal San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000022183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1677</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:11:56.341Z</lastUpdated>
  </row>
</eudamedExport>