<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959426597</udiDi>
    <basicUdiDi>B-00606959426597</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AAM, MedicAir, Respi Comfort</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AAM, MedicAir, Respi Comfort</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>MDX1130S25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:28:59.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426580</udiDi>
    <basicUdiDi>B-00606959426580</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AAM, w/ Humidifier,Linde EOLUS</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AAM, w/ Humidifier,Linde EOLUS</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>LDX1130H23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:28:58.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426573</udiDi>
    <basicUdiDi>B-00606959426573</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AAM, Linde EOLUS</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AAM, Linde EOLUS</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>LDX1130S23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:28:54.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426566</udiDi>
    <basicUdiDi>B-00606959426566</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AAM no Bluetooth, UA</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AAM no Bluetooth, UA</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>UAX1130S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:28:53.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426559</udiDi>
    <basicUdiDi>B-00606959426559</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AAM w/Humid, NO Bluetooth, UA</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AAM w/Humid, NO Bluetooth, UA</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>UAX1130H19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:28:52.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426535</udiDi>
    <basicUdiDi>B-00606959426535</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AAM, TR</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AAM, 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRX1130S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:28:47.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426511</udiDi>
    <basicUdiDi>B-00606959426511</basicUdiDi>
    <tradeName>DreamStation AVAPS 30, ND</tradeName>
    <deviceName>DreamStation AVAPS 30, 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDX1130S20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:28:46.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426504</udiDi>
    <basicUdiDi>B-00606959426504</basicUdiDi>
    <tradeName>DreamStation AVAPS 30 with Heated Humidifier, AAM ND</tradeName>
    <deviceName>DreamStation AVAPS 30 with Heated Humidifier, AAM 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDX1130H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:28:45.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426498</udiDi>
    <basicUdiDi>B-00606959426498</basicUdiDi>
    <tradeName>DreamStation AVAPS 30 AAM ND</tradeName>
    <deviceName>DreamStation AVAPS 30 AAM 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDX1130S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:26:57.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426481</udiDi>
    <basicUdiDi>B-00606959426481</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30, IT</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 30, 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITX1130S21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:26:55.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426474</udiDi>
    <basicUdiDi>B-00606959426474</basicUdiDi>
    <tradeName>DreamStation AVAPS 25, IT</tradeName>
    <deviceName>DreamStation AVAPS 25, 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITX1125S21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:26:54.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426467</udiDi>
    <basicUdiDi>B-00606959426467</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30 w/Heated Humidifier AAM, FR</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 30 w/Heated Humidifier AAM, FR</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>FRX1130H14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:26:53.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426450</udiDi>
    <basicUdiDi>B-00606959426450</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AAM, FR</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AAM, FR</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>FRX1130S14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:26:51.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426443</udiDi>
    <basicUdiDi>B-00606959426443</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30 w/Heated Humidifier, AAM EU</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 30 w/Heated Humidifier, 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>EUX1130H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:26:49.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426436</udiDi>
    <basicUdiDi>B-00606959426436</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30 AAM, EU</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 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>EUX1130S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:26:47.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426412</udiDi>
    <basicUdiDi>B-00606959426412</basicUdiDi>
    <tradeName>DreamStation AVAPS 25, EU</tradeName>
    <deviceName>DreamStation AVAPS 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>EUX1125S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:26:44.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426405</udiDi>
    <basicUdiDi>B-00606959426405</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30 w/HTD Humid, No BT, EU</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 30 w/HTD Humid, No BT, 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>EUX1130H19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:26:42.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426375</udiDi>
    <basicUdiDi>B-00606959426375</basicUdiDi>
    <tradeName>DreamStation AVAPS 25, No Bluetooth, EU</tradeName>
    <deviceName>DreamStation AVAPS 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>EUX1125S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:26:38.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426368</udiDi>
    <basicUdiDi>B-00606959426368</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30, AAM w/ Humidifier, ES</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 30, AAM 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>ESX1130H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:26:35.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426337</udiDi>
    <basicUdiDi>B-00606959426337</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AAM, EE</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AAM, 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>EEX1130S22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:26:31.057Z</lastUpdated>
  </row>
</eudamedExport>