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<eudamedExport entity="devices">
  <row>
    <udiDi>00606959426023</udiDi>
    <basicUdiDi>B-00606959426023</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T30 AAM BL</tradeName>
    <deviceName>DreamStation BiPAP S/T30 AAM BL</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>BLX1030S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:25.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426016</udiDi>
    <basicUdiDi>B-00606959426016</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30 w/Heated Humidifier, GB</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 30 w/Heated Humidifier, GB</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>GBX1130H20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:24.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426009</udiDi>
    <basicUdiDi>B-00606959426009</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30, GB</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 30, GB</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>GBX1130S20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:23.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425996</udiDi>
    <basicUdiDi>B-00606959425996</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T 30 with Heated Humidifier, GB</tradeName>
    <deviceName>DreamStation BiPAP S/T 30 with Heated Humidifier, GB</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>GBX1030H20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:19.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425989</udiDi>
    <basicUdiDi>B-00606959425989</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T 30, GB</tradeName>
    <deviceName>DreamStation BiPAP S/T 30, GB</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>GBX1030S20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:18.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425125</udiDi>
    <basicUdiDi>B-00606959425125</basicUdiDi>
    <tradeName>DreamStation AVAPS 30 AE AAM w/Hum w/HTube, no BT, INTL</tradeName>
    <deviceName>DreamStation AVAPS 30 AE AAM w/Hum w/HTube, no BT, 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX1131T19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:24:25.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425118</udiDi>
    <basicUdiDi>B-00606959425118</basicUdiDi>
    <tradeName>DreamSt BiPAP AVAPS 30 AE w/HTD Humid, No Btooth, INTL</tradeName>
    <deviceName>DreamSt BiPAP AVAPS 30 AE w/HTD Humid, No Btooth, 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX1131H19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:24:24.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425101</udiDi>
    <basicUdiDi>B-00606959425101</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30 AE No Bluetooth. INTL</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 30 AE No Bluetooth. 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX1131S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:24:23.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425095</udiDi>
    <basicUdiDi>B-00606959425095</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30 w/Hum w/HTube, No BT, INTL</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 30 w/Hum w/HTube, No BT, 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX1130T19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:24:22.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425088</udiDi>
    <basicUdiDi>B-00606959425088</basicUdiDi>
    <tradeName>DreamStation AVAPS 30 AAM w/Hum,no Bluetooth, INTL</tradeName>
    <deviceName>DreamStation AVAPS 30 AAM w/Hum,no Bluetooth, 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX1130H19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:24:18.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425064</udiDi>
    <basicUdiDi>B-00606959425064</basicUdiDi>
    <tradeName>DreamStation AVAPS 25 w/Humid w/H Tube, no Bluetooth, INTL</tradeName>
    <deviceName>DreamStation AVAPS 25 w/Humid w/H Tube, no Bluetooth, 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX1125T19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:24:17.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425057</udiDi>
    <basicUdiDi>B-00606959425057</basicUdiDi>
    <tradeName>DreamStation AVAPS 25 w/Hum,no Bluetooth, INTL</tradeName>
    <deviceName>DreamStation AVAPS 25 w/Hum,no Bluetooth, 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX1125H19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:24:16.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425040</udiDi>
    <basicUdiDi>B-00606959425040</basicUdiDi>
    <tradeName>DreamStation AVAPS 25, no Bluetooth, Intl</tradeName>
    <deviceName>DreamStation AVAPS 25, no Bluetooth, 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX1125S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:24:01.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425033</udiDi>
    <basicUdiDi>B-00606959425033</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T30 AAM w/Hum w/HTube, no BT,INTL</tradeName>
    <deviceName>DreamStation BiPAP S/T30 AAM w/Hum w/HTube, no BT,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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX1030T19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:24:00.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425019</udiDi>
    <basicUdiDi>B-00606959425019</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T25 w/Hum w/H Tube, no BT, INTL</tradeName>
    <deviceName>DreamStation BiPAP S/T25 w/Hum w/H Tube, no BT, 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX1025T19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:23:55.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425002</udiDi>
    <basicUdiDi>B-00606959425002</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T25, no Bluetooth, INTL</tradeName>
    <deviceName>DreamStation BiPAP S/T25, no Bluetooth, 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX1025S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:23:54.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424999</udiDi>
    <basicUdiDi>B-00606959424999</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/WiFi AU</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/WiFi AU</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>AUX1131T15W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:23:53.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424982</udiDi>
    <basicUdiDi>B-00606959424982</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AE w/WiFi, AU</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AE w/WiFi, AU</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>AUX1131S15W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:23:49.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424951</udiDi>
    <basicUdiDi>B-00606959424951</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AE w/Cell, AU</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AE w/Cell, AU</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>AUX1131S15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:23:47.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424937</udiDi>
    <basicUdiDi>B-00606959424937</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30 AE w/Humid w/H Tube, AU</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 30 AE w/Humid w/H Tube, AU</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>AUX1131T15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:23:42.773Z</lastUpdated>
  </row>
</eudamedExport>