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<eudamedExport entity="devices">
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    <udiDi>00606959420229</udiDi>
    <basicUdiDi>B-00606959420229</basicUdiDi>
    <tradeName>AW CT Takeda TAK-925-2001 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>1144736</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:45.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959420915</udiDi>
    <basicUdiDi>B-00606959420915</basicUdiDi>
    <tradeName>Philips NightBalance, Refurbishment Kit, Canada</tradeName>
    <deviceName>NightBalance</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>RPL2US01CA</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:44.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959420304</udiDi>
    <basicUdiDi>B-00606959420304</basicUdiDi>
    <tradeName>AW CT Immusoft MT2018-18 Pkg Scorer</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>Piyasada</deviceStatus>
    <reference>1144978</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:43.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959420212</udiDi>
    <basicUdiDi>B-00606959420212</basicUdiDi>
    <tradeName>AW CT Takeda TAK-925-2001 Pkg Scorer</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>1144735</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:25.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959419971</udiDi>
    <basicUdiDi>B-00606959419971</basicUdiDi>
    <tradeName>Philips NightBalance, Refurbishment Kit, DK</tradeName>
    <deviceName>NightBalance</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>Piyasada</deviceStatus>
    <reference>RPL2EU01DK</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:25.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959419964</udiDi>
    <basicUdiDi>B-00606959419964</basicUdiDi>
    <tradeName>Philips NightBalance, Refurbishment Kit, FR</tradeName>
    <deviceName>NightBalance</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>RPL2EU01FR</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:23.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959419957</udiDi>
    <basicUdiDi>B-00606959419957</basicUdiDi>
    <tradeName>Philips NightBalance, Refurbishment Kit, DE</tradeName>
    <deviceName>NightBalance</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>RPL2EU01DE</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:22.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959419940</udiDi>
    <basicUdiDi>B-00606959419940</basicUdiDi>
    <tradeName>Philips NightBalance, Refurbishment Kit, UK</tradeName>
    <deviceName>NightBalance</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>RPL2EU01UK</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:18.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959419933</udiDi>
    <basicUdiDi>B-00606959419933</basicUdiDi>
    <tradeName>Philips NightBalance, Refurbishment Kit, NL</tradeName>
    <deviceName>NightBalance</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>RPL2EU01NL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:17.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959419902</udiDi>
    <basicUdiDi>B-00606959419902</basicUdiDi>
    <tradeName>CT XyloCor XC001-1001 SW Pkg Scorer</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>1143903</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:16.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959419896</udiDi>
    <basicUdiDi>B-00606959419896</basicUdiDi>
    <tradeName>AW CT Takeda TAK-994-1501 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>1143718</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:16.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959419803</udiDi>
    <basicUdiDi>B-00606959419803</basicUdiDi>
    <tradeName>CT Sanofi LPS15497 Software 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>1143211</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:12.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959419797</udiDi>
    <basicUdiDi>B-00606959419797</basicUdiDi>
    <tradeName>CT Sanofi LPS15497 Software Pkg Scorer-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>1143210</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:11.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959419629</udiDi>
    <basicUdiDi>B-00606959419629</basicUdiDi>
    <tradeName>Philips NightBalance Mobile App, Android</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>1142207</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:10.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959419612</udiDi>
    <basicUdiDi>B-00606959419612</basicUdiDi>
    <tradeName>Philips NightBalance Mobile App, iOS</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>1142206</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:08.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959418998</udiDi>
    <basicUdiDi>B-00606959418998</basicUdiDi>
    <tradeName>AW CT Regeneron R3500-AD-1798 Pkg Scorer</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>1140958</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:04.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959418882</udiDi>
    <basicUdiDi>B-00606959418882</basicUdiDi>
    <tradeName>AW CT Angelini 152PO17433 Pkg Scorer</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>Piyasada</deviceStatus>
    <reference>1140687</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:04.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959418769</udiDi>
    <basicUdiDi>B-00606959418769</basicUdiDi>
    <tradeName>AW CT Ovid OV101-17-002 Pkg Scorer</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>1140325</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:03.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959418103</udiDi>
    <basicUdiDi>B-00606959418103</basicUdiDi>
    <tradeName>AW CT Janssen 42756493BLC3001 Pkg Scorer</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>1139805</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:02.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959417540</udiDi>
    <basicUdiDi>B-00606959417540</basicUdiDi>
    <tradeName>Micro-Flexible Heated 12mm Tube</tradeName>
    <deviceName>DreamStation 2</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>Artık piyasada değil</deviceStatus>
    <reference>HT12</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:58.578Z</lastUpdated>
  </row>
</eudamedExport>