<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>40606959402261</udiDi>
    <basicUdiDi>B-40606959402261</basicUdiDi>
    <tradeName>Flex Trach Adapt 15cm,22M/15F-15 10pk</tradeName>
    <deviceName>Flex Trach Adapt 15cm,22M/15F-15 10pk</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>1073863</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:41:14.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>40606959026061</udiDi>
    <basicUdiDi>B-40606959026061</basicUdiDi>
    <tradeName>Disposable Pediatric Passive Circuit with H20 Trap 20 pk</tradeName>
    <deviceName>Disposable Pediatric Passive Circuit with H20 Trap 20 pk</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>1073233</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:41:12.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>40606959026054</udiDi>
    <basicUdiDi>B-40606959026054</basicUdiDi>
    <tradeName>Disposable Adult Active Circuit no H20 Trap 20 pk</tradeName>
    <deviceName>Disposable Adult Active Circuit no H20 Trap 20 pk</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>1073232</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:41:10.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>40606959024227</udiDi>
    <basicUdiDi>B-40606959024227</basicUdiDi>
    <tradeName>Disposable Pediatric Active Circuit with H20 Trap 20 pk</tradeName>
    <deviceName>Disposable Pediatric Active Circuit with H20 Trap 20 pk</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>1073229</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:41:06.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959402271</udiDi>
    <basicUdiDi>B-30606959402271</basicUdiDi>
    <tradeName>Flex Trach Adapt 15cm,22M/15F-22F10pk</tradeName>
    <deviceName>Flex Trach Adapt 15cm,22M/15F-22F10pk</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>1073902</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:41:06.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959061188</udiDi>
    <basicUdiDi>B-30606959061188</basicUdiDi>
    <tradeName>Disposable Ext Flow Sensor,Ped/Inf, 10pk</tradeName>
    <deviceName>Disposable Ext Flow Sensor,Ped/Inf, 10pk</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>1146558</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:41:02.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959061171</udiDi>
    <basicUdiDi>B-30606959061171</basicUdiDi>
    <tradeName>Disp Ext Flow Sensor,Adult/Ped, 10 pk</tradeName>
    <deviceName>Disp Ext Flow Sensor,Adult/Ped, 10 pk</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>1146497</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:41:01.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959054517</udiDi>
    <basicUdiDi>B-30606959054517</basicUdiDi>
    <tradeName>Disposable Swivel Passive Exhalation Port</tradeName>
    <deviceName>Disposable Swivel Passive Exhalation Port</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>1139909</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:41:00.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959051844</udiDi>
    <basicUdiDi>B-30606959051844</basicUdiDi>
    <tradeName>Dual Limb Active Exhalation Valve</tradeName>
    <deviceName>Dual Limb Active Exhalation Valve</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>1139436</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:40:57.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959049605</udiDi>
    <basicUdiDi>B-30606959049605</basicUdiDi>
    <tradeName>(10) Circuit,Disp,15mm,Non-Htd,Dual Limb</tradeName>
    <deviceName>(10) Circuit,Disp,15mm,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>1127307</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:40:39.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959049582</udiDi>
    <basicUdiDi>B-30606959049582</basicUdiDi>
    <tradeName>(10) Circuit,Disp,22mm,Non-Htd,Active</tradeName>
    <deviceName>(10) Circuit,Disp,22mm,Non-Htd,Active</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>1132344</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:40:38.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959043023</udiDi>
    <basicUdiDi>B-30606959043023</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>1102866</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:40:34.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959042330</udiDi>
    <basicUdiDi>B-30606959042330</basicUdiDi>
    <tradeName>Circuit, DEP w/FEP, INTL, 10 Pack</tradeName>
    <deviceName>Circuit, DEP w/FEP, INTL, 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1069210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:40:32.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959026217</udiDi>
    <basicUdiDi>B-30606959026217</basicUdiDi>
    <tradeName>Pediatric Invasive Passive Disposable Non-Heated Circuit</tradeName>
    <deviceName>Pediatric Invasive Passive Disposable Non-Heated 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>1069445</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:40:30.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959026200</udiDi>
    <basicUdiDi>B-30606959026200</basicUdiDi>
    <tradeName>Adult Non-Invasive Passive Disposable Non-Heated Circuit</tradeName>
    <deviceName>Adult Non-Invasive Passive Disposable Non-Heated 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>1069467</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:40:29.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959026170</udiDi>
    <basicUdiDi>B-30606959026170</basicUdiDi>
    <tradeName>Adult Invasive Passive Disposable Non-Heated Wire Circuit</tradeName>
    <deviceName>Adult Invasive Passive Disposable Non-Heated Wire 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>1069443</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:40:27.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959026071</udiDi>
    <basicUdiDi>B-30606959026071</basicUdiDi>
    <tradeName>Disposable Adult Passve Circuit no H2O Trap</tradeName>
    <deviceName>Disposable Adult Passve Circuit no H2O Trap</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>1073228</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:40:26.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959026064</udiDi>
    <basicUdiDi>B-30606959026064</basicUdiDi>
    <tradeName>Disposable Pediatric Passive Circuit with H2O Trap</tradeName>
    <deviceName>Disposable Pediatric Passive Circuit with H2O Trap</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>1073224</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:40:24.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959026057</udiDi>
    <basicUdiDi>B-30606959026057</basicUdiDi>
    <tradeName>Disposable Adult Active Circuit no H2O Trap</tradeName>
    <deviceName>Disposable Adult Active Circuit no H2O Trap</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>1073223</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:40:22.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959490246</udiDi>
    <basicUdiDi>B-00606959490246</basicUdiDi>
    <tradeName>DreamStation Auto CPAP w/Humidifier/Cell, ND</tradeName>
    <deviceName>DreamStation Auto CPAP w/Humidifier/Cell, ND</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDX500H15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:33:27.571Z</lastUpdated>
  </row>
</eudamedExport>