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<eudamedExport entity="devices">
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    <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>
  <row>
    <udiDi>00606959037076</udiDi>
    <basicUdiDi>B-00606959037076</basicUdiDi>
    <tradeName>Dorma 500 Auto, with Humidifier, TR</tradeName>
    <deviceName>REMstar, REMstar SE, Dorma</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>TRV501H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:27.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959037069</udiDi>
    <basicUdiDi>B-00606959037069</basicUdiDi>
    <tradeName>Dorma 500 Auto, TR</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>Z1203010502</emdnCode>
    <emdnDescription>ADULT PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>TRV501</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:26.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959037045</udiDi>
    <basicUdiDi>B-00606959037045</basicUdiDi>
    <tradeName>Dorma 200, with Humidifier, LD</tradeName>
    <deviceName>REMstar, REMstar SE, Dorma</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>LDV201H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:25.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959037038</udiDi>
    <basicUdiDi>B-00606959037038</basicUdiDi>
    <tradeName>Dorma 200, LD</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>Z1203010502</emdnCode>
    <emdnDescription>ADULT PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LDV201</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:25.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959036956</udiDi>
    <basicUdiDi>B-00606959036956</basicUdiDi>
    <tradeName>Dorma 500 Auto, with Humidifier, INTL</tradeName>
    <deviceName>REMstar, REMstar SE, Dorma</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>INV501H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:21.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959036925</udiDi>
    <basicUdiDi>B-00606959036925</basicUdiDi>
    <tradeName>REMstar SE with Heated Tube, with SD Slot, INTL</tradeName>
    <deviceName>REMstar, REMstar SE, Dorma</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>IN221TS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:19.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959036918</udiDi>
    <basicUdiDi>B-00606959036918</basicUdiDi>
    <tradeName>REMstar SE with HUMIDIFIER, with SD Slot, INTL</tradeName>
    <deviceName>REMstar, REMstar SE, Dorma</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>IN221HS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:18.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959036901</udiDi>
    <basicUdiDi>B-00606959036901</basicUdiDi>
    <tradeName>Dorma 200  w/Humid, 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>Z1203010502</emdnCode>
    <emdnDescription>ADULT PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INV201H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:17.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959036895</udiDi>
    <basicUdiDi>B-00606959036895</basicUdiDi>
    <tradeName>Dorma 200, INTL</tradeName>
    <deviceName>REMstar, REMstar SE, Dorma</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>INV201</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:13.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959036864</udiDi>
    <basicUdiDi>B-00606959036864</basicUdiDi>
    <tradeName>Dorma 500 Auto, with Humidifier, IN</tradeName>
    <deviceName>REMstar, REMstar SE, Dorma</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>INDV501H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:13.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959036857</udiDi>
    <basicUdiDi>B-00606959036857</basicUdiDi>
    <tradeName>Dorma 500 Auto, IN</tradeName>
    <deviceName>REMstar, REMstar SE, Dorma</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>INDV501</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:12.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959036840</udiDi>
    <basicUdiDi>B-00606959036840</basicUdiDi>
    <tradeName>Dorma 500 Auto, w/ Humid, DE</tradeName>
    <deviceName>REMstar System (60 Series)</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>DEV502H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:11.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959036826</udiDi>
    <basicUdiDi>B-00606959036826</basicUdiDi>
    <tradeName>Dorma 400 w/Humid, DE</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>Z1203010502</emdnCode>
    <emdnDescription>ADULT PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DEV402H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:06.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959036802</udiDi>
    <basicUdiDi>B-00606959036802</basicUdiDi>
    <tradeName>Dorma 200 with Humidifier, FR</tradeName>
    <deviceName>REMstar, REMstar SE, Dorma</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>FRV201H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:05.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959036796</udiDi>
    <basicUdiDi>B-00606959036796</basicUdiDi>
    <tradeName>Dorma 200, FR</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>Z1203010502</emdnCode>
    <emdnDescription>ADULT PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FRV201</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:05.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959033924</udiDi>
    <basicUdiDi>B-00606959033924</basicUdiDi>
    <tradeName>Trilogy 200 Ventilator, Germany-Recert</tradeName>
    <deviceName>Trilogy 200</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>U1032802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:04.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959033917</udiDi>
    <basicUdiDi>B-00606959033917</basicUdiDi>
    <tradeName>Trilogy 200 Ventilator, Intl-Recert</tradeName>
    <deviceName>Trilogy 200</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>U1032800</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:06:15.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959033870</udiDi>
    <basicUdiDi>B-00606959033870</basicUdiDi>
    <tradeName>Trilogy 202 Ventilator,Intl-RENTAL</tradeName>
    <deviceName>Trilogy 202/O2</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>R1040000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:06:14.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959033856</udiDi>
    <basicUdiDi>B-00606959033856</basicUdiDi>
    <tradeName>Trilogy 200 Ventilator, Germany-Rental</tradeName>
    <deviceName>Trilogy 200</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>R1032802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:06:12.959Z</lastUpdated>
  </row>
</eudamedExport>