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<eudamedExport entity="devices">
  <row>
    <udiDi>00606959426177</udiDi>
    <basicUdiDi>B-00606959426177</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T 30 AAM , No Bluetooth, EU</tradeName>
    <deviceName>DreamStation BiPAP S/T 30 AAM , No Bluetooth, EU</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>EUX1030S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:50.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426153</udiDi>
    <basicUdiDi>B-00606959426153</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T 25, no Bluetooth, EU</tradeName>
    <deviceName>DreamStation BiPAP S/T 25, no Bluetooth, EU</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>EUX1025S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:45.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426139</udiDi>
    <basicUdiDi>B-00606959426139</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T 30 AAM, EU</tradeName>
    <deviceName>DreamStation BiPAP S/T 30 AAM, EU</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>EUX1030S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:43.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426122</udiDi>
    <basicUdiDi>B-00606959426122</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T 25 w/Heated Humidifier, EU</tradeName>
    <deviceName>DreamStation BiPAP S/T 25 w/Heated Humidifier, EU</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>EUX1025H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:42.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426115</udiDi>
    <basicUdiDi>B-00606959426115</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T 25, EU</tradeName>
    <deviceName>DreamStation BiPAP S/T 25, EU</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>EUX1025S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:38.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426108</udiDi>
    <basicUdiDi>B-00606959426108</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T30 w/ Humidifier, ES</tradeName>
    <deviceName>DreamStation BiPAP S/T30 w/ Humidifier, ES</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>ESX1030H20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:38.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426092</udiDi>
    <basicUdiDi>B-00606959426092</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T30, ES</tradeName>
    <deviceName>DreamStation BiPAP S/T30, ES</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>ESX1030S20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:37.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426085</udiDi>
    <basicUdiDi>B-00606959426085</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T 30 AAM w/Heated Humidifier, ES</tradeName>
    <deviceName>DreamStation BiPAP S/T 30 AAM w/Heated Humidifier, ES</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>ESX1030H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:36.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426054</udiDi>
    <basicUdiDi>B-00606959426054</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T30, EE</tradeName>
    <deviceName>DreamStation BiPAP S/T30, EE</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>EEX1030S22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:30.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426030</udiDi>
    <basicUdiDi>B-00606959426030</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T30 AAM w/Humidifier, BL</tradeName>
    <deviceName>DreamStation BiPAP S/T30 AAM w/Humidifier, 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>BLX1030H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:26.151Z</lastUpdated>
  </row>
  <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>00606959425972</udiDi>
    <basicUdiDi>B-00606959425972</basicUdiDi>
    <tradeName>DreamStation AutoSV, Ukraine</tradeName>
    <deviceName>DreamStation AutoSV, Ukraine</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UAX900S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:18.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425958</udiDi>
    <basicUdiDi>B-00606959425958</basicUdiDi>
    <tradeName>DreamStation BiPAP autoSV, TR</tradeName>
    <deviceName>DreamStation BiPAP autoSV, TR</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRX900S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:02.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425941</udiDi>
    <basicUdiDi>B-00606959425941</basicUdiDi>
    <tradeName>DreamStation, BiPAP AutoSV with Humidifier, IT</tradeName>
    <deviceName>DreamStation, BiPAP AutoSV with Humidifier, IT</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITX900H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:25:01.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425934</udiDi>
    <basicUdiDi>B-00606959425934</basicUdiDi>
    <tradeName>DreamStation BiPAP AutoSV, IT</tradeName>
    <deviceName>DreamStation BiPAP AutoSV, IT</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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITX900S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:24:57.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425927</udiDi>
    <basicUdiDi>B-00606959425927</basicUdiDi>
    <tradeName>DreamStation BiPAP autoSV with Humidifier, ND</tradeName>
    <deviceName>DreamStation BiPAP autoSV with Humidifier, 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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDX900H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:24:56.491Z</lastUpdated>
  </row>
</eudamedExport>