<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959426160</udiDi>
    <basicUdiDi>B-00606959426160</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T 25 w/ HTD Humid, No BT, EU</tradeName>
    <deviceName>DreamStation BiPAP S/T 25 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>EUX1025H19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:46.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426146</udiDi>
    <basicUdiDi>B-00606959426146</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T 30 AAM w/Heated Humidifier, EU</tradeName>
    <deviceName>DreamStation BiPAP S/T 30 AAM 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>EUX1030H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:46.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426061</udiDi>
    <basicUdiDi>B-00606959426061</basicUdiDi>
    <tradeName>DreamStation S/T 30 w/Heated Humidifier, EE</tradeName>
    <deviceName>DreamStation S/T 30 w/Heated Humidifier, 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>EEX1030H22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:45.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426047</udiDi>
    <basicUdiDi>B-00606959426047</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T 25, DE</tradeName>
    <deviceName>DreamStation BiPAP S/T 25, DE</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>DEX1025S13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:29.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425965</udiDi>
    <basicUdiDi>B-00606959425965</basicUdiDi>
    <tradeName>DreamStation BiPAP autoSV w/Humidifier, TR</tradeName>
    <deviceName>DreamStation BiPAP autoSV w/Humidifier, 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>TRX900H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:28.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425866</udiDi>
    <basicUdiDi>B-00606959425866</basicUdiDi>
    <tradeName>DreamStation BiPAP autoSV , No Bluetooth, EU</tradeName>
    <deviceName>DreamStation BiPAP autoSV , 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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EUX900S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:26.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425842</udiDi>
    <basicUdiDi>B-00606959425842</basicUdiDi>
    <tradeName>DreamStation BiPAP AutoSV, EU</tradeName>
    <deviceName>DreamStation BiPAP AutoSV, 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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EUX900S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:24.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425798</udiDi>
    <basicUdiDi>B-00606959425798</basicUdiDi>
    <tradeName>DreamStation, BiPAP AutoSV with Humidifier, DE</tradeName>
    <deviceName>DreamStation, BiPAP AutoSV with Humidifier, DE</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>DEX900H13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:22.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425774</udiDi>
    <basicUdiDi>B-00606959425774</basicUdiDi>
    <tradeName>DreamStation BiPAP autoSV w/Humidifier, BL</tradeName>
    <deviceName>DreamStation BiPAP autoSV 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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLX900H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:21.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425071</udiDi>
    <basicUdiDi>B-00606959425071</basicUdiDi>
    <tradeName>DreamStation AVAPS 30 AAM, no Bluetooth, INTL</tradeName>
    <deviceName>DreamStation AVAPS 30 AAM, 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>INX1130S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:20.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959425026</udiDi>
    <basicUdiDi>B-00606959425026</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T30 AAM no Bluetooth, INTL</tradeName>
    <deviceName>DreamStation BiPAP S/T30 AAM 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>INX1030S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:17.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424975</udiDi>
    <basicUdiDi>B-00606959424975</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi, AU</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AE w/Humidifier 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>AUX1131H15W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:16.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424968</udiDi>
    <basicUdiDi>B-00606959424968</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/Cell, AU</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AE w/Humd w/H Tube 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>AUX1131T15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:15.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424944</udiDi>
    <basicUdiDi>B-00606959424944</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AE w/Humidifier w/Cell, AU</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AE w/Humidifier 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>AUX1131H15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:13.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424852</udiDi>
    <basicUdiDi>B-00606959424852</basicUdiDi>
    <tradeName>DreamStation BiPAP autoSV w/Humid w/H tube w/Cell, AU</tradeName>
    <deviceName>DreamStation BiPAP autoSV w/Humid w/H tube 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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AUX900T15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:11.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424807</udiDi>
    <basicUdiDi>B-00606959424807</basicUdiDi>
    <tradeName>DreamStation CPAP Pro, INTL</tradeName>
    <deviceName>DreamStation CPAP Pro, 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX400S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:10.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424777</udiDi>
    <basicUdiDi>B-00606959424777</basicUdiDi>
    <tradeName>DreamStation BiPAP Pro with Humidifier, INTL</tradeName>
    <deviceName>DreamStation BiPAP Pro with Humidifier, 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX600H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:09.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424722</udiDi>
    <basicUdiDi>B-00606959424722</basicUdiDi>
    <tradeName>DreamStation CPAP Pro w/Humid w/H Tube, INTL</tradeName>
    <deviceName>DreamStation CPAP Pro w/Humid w/H Tube, 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX400T15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:07.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424715</udiDi>
    <basicUdiDi>B-00606959424715</basicUdiDi>
    <tradeName>DreamStation CPAP Pro with Humidifier, INTL</tradeName>
    <deviceName>DreamStation CPAP Pro with Humidifier, 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX400H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:05.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959424692</udiDi>
    <basicUdiDi>B-00606959424692</basicUdiDi>
    <tradeName>DreamStation CPAP with Humidifier, INTL</tradeName>
    <deviceName>DreamStation CPAP with Humidifier, 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX200H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:03.542Z</lastUpdated>
  </row>
</eudamedExport>