<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959427419</udiDi>
    <basicUdiDi>B-00606959427419</basicUdiDi>
    <tradeName>DreamStation CPAP, BL</tradeName>
    <deviceName>DreamStation CPAP, 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLX200S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:00:18.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959427365</udiDi>
    <basicUdiDi>B-00606959427365</basicUdiDi>
    <tradeName>DreamStation Auto CPAP with Humidifier, GB</tradeName>
    <deviceName>DreamStation Auto CPAP with 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBX500H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:00:18.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959427358</udiDi>
    <basicUdiDi>B-00606959427358</basicUdiDi>
    <tradeName>DreamStation Auto CPAP, GB</tradeName>
    <deviceName>DreamStation Auto CPAP, 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBX500S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:00:17.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959427334</udiDi>
    <basicUdiDi>B-00606959427334</basicUdiDi>
    <tradeName>DreamStation CPAP Pro with C-Flex, GB</tradeName>
    <deviceName>DreamStation CPAP Pro with C-Flex, 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBX401S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:00:13.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959427235</udiDi>
    <basicUdiDi>B-00606959427235</basicUdiDi>
    <tradeName>DreamStation CPAP Pro with Humidifier, GB</tradeName>
    <deviceName>DreamStation CPAP Pro with 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBX400H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:00:12.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426658</udiDi>
    <basicUdiDi>B-00606959426658</basicUdiDi>
    <tradeName>DreamStation AVAPS30 AAM, VT</tradeName>
    <deviceName>DreamStation AVAPS30 AAM, VT</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>VTX1130S24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:00:11.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426634</udiDi>
    <basicUdiDi>B-00606959426634</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 with Humidifier, SP</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 with Humidifier, SP</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>SPX1130H21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:00:10.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426542</udiDi>
    <basicUdiDi>B-00606959426542</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AAM w/Humidifier, TR</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 AAM 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRX1130H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:00:06.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426528</udiDi>
    <basicUdiDi>B-00606959426528</basicUdiDi>
    <tradeName>DreamStation AVAPS 30 with Heated Humidifier, ND</tradeName>
    <deviceName>DreamStation AVAPS 30 with Heated 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDX1130H20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:00:06.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426429</udiDi>
    <basicUdiDi>B-00606959426429</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30 w/Heated Humidifier, EU</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 30 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>EUX1125H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:00:05.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426399</udiDi>
    <basicUdiDi>B-00606959426399</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30 AAM no Bluetooth, EU</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 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>EUX1130S19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:00:04.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426382</udiDi>
    <basicUdiDi>B-00606959426382</basicUdiDi>
    <tradeName>DreamStation AVAPS 25 w/Heated Humidifier, No Bluetooth, EU</tradeName>
    <deviceName>DreamStation AVAPS 25 w/Heated Humidifier, 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>EUX1125H19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:00:00.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426351</udiDi>
    <basicUdiDi>B-00606959426351</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30 AAM, ES</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 30 AAM, 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>ESX1130S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:59.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426344</udiDi>
    <basicUdiDi>B-00606959426344</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS 30 w/Heated Humidifier, AAM EE</tradeName>
    <deviceName>DreamStation BiPAP AVAPS 30 w/Heated Humidifier, 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>EEX1130H22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:58.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426306</udiDi>
    <basicUdiDi>B-00606959426306</basicUdiDi>
    <tradeName>DreamStation BiPAP AVAPS30 AAM w/Humidifier, BL</tradeName>
    <deviceName>DreamStation BiPAP AVAPS30 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>BLX1130H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:58.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426276</udiDi>
    <basicUdiDi>B-00606959426276</basicUdiDi>
    <tradeName>DreamStation BiPAP ST30 AAM w/Humid, no Bluetooth, UA</tradeName>
    <deviceName>DreamStation BiPAP ST30 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>UAX1030H19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:54.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426238</udiDi>
    <basicUdiDi>B-00606959426238</basicUdiDi>
    <tradeName>DreamStation ST 30, ND</tradeName>
    <deviceName>DreamStation ST 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>NDX1030S20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:53.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426207</udiDi>
    <basicUdiDi>B-00606959426207</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T30 with Humidifier, IT</tradeName>
    <deviceName>DreamStation BiPAP S/T30 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITX1030H20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:52.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426191</udiDi>
    <basicUdiDi>B-00606959426191</basicUdiDi>
    <tradeName>DreamStation, BiPAP S/T30, FR</tradeName>
    <deviceName>DreamStation, BiPAP S/T30, 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>FRX1030S14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:51.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959426078</udiDi>
    <basicUdiDi>B-00606959426078</basicUdiDi>
    <tradeName>DreamStation BiPAP S/T ST30 AAM, ES</tradeName>
    <deviceName>DreamStation BiPAP S/T ST30 AAM, 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>ESX1030S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:59:47.615Z</lastUpdated>
  </row>
</eudamedExport>