<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959030749</udiDi>
    <basicUdiDi>B-00606959030749</basicUdiDi>
    <tradeName>DreamWear Under Nose Mask MW, M Frame w/Headgear, Global</tradeName>
    <deviceName>DreamWear Under the Nose</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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1116683</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:40.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959030688</udiDi>
    <basicUdiDi>B-00606959030688</basicUdiDi>
    <tradeName>M DreamWear Under the Nose Nasal, Med Frame W/HGR, GBL</tradeName>
    <deviceName></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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1116681</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:24.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959030275</udiDi>
    <basicUdiDi>B-00606959030275</basicUdiDi>
    <tradeName>REMstar Pro C-Flex+, w/HT Humid System One 60 Series INT</tradeName>
    <deviceName></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>Artık piyasada değil</deviceStatus>
    <reference>IN461TS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:24.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029903</udiDi>
    <basicUdiDi>B-00606959029903</basicUdiDi>
    <tradeName>REMstar Plus C-Flex, w/H Tube Humid, 60 Series, INTL</tradeName>
    <deviceName>REMstar System (60 Series)</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>Artık piyasada değil</deviceStatus>
    <reference>IN261TS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:22.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029880</udiDi>
    <basicUdiDi>B-00606959029880</basicUdiDi>
    <tradeName>REMstar Plus C-Flex, 60 Series, INTL</tradeName>
    <deviceName>REMstar System (60 Series)</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>Artık piyasada değil</deviceStatus>
    <reference>IN261S</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:20.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029842</udiDi>
    <basicUdiDi>B-00606959029842</basicUdiDi>
    <tradeName>BiPAP autoSV ADV w/ HT Humid, 60 Series, 30cm INTL</tradeName>
    <deviceName></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>Artık piyasada değil</deviceStatus>
    <reference>IN961XTS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:18.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029828</udiDi>
    <basicUdiDi>B-00606959029828</basicUdiDi>
    <tradeName>BiPAP autoSV ADV, w/Humid 60 Series, 30cm, INTL</tradeName>
    <deviceName></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>Artık piyasada değil</deviceStatus>
    <reference>IN961XHS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:17.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029781</udiDi>
    <basicUdiDi>B-00606959029781</basicUdiDi>
    <tradeName>BiPAP autoSV ADV 60 Series, 30cm DE</tradeName>
    <deviceName></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>Artık piyasada değil</deviceStatus>
    <reference>DE962XS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:16.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029705</udiDi>
    <basicUdiDi>B-00606959029705</basicUdiDi>
    <tradeName>BiPAP autoSV ADV SYS ONE w/HT Humid, 60 Series, GER</tradeName>
    <deviceName></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>Artık piyasada değil</deviceStatus>
    <reference>DE962TS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:13.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029699</udiDi>
    <basicUdiDi>B-00606959029699</basicUdiDi>
    <tradeName>BiPAP autoSV ADV SYS ONE w/Humid, 60 Series, GER</tradeName>
    <deviceName></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>Artık piyasada değil</deviceStatus>
    <reference>DE962HS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:12.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029644</udiDi>
    <basicUdiDi>B-00606959029644</basicUdiDi>
    <tradeName>BiPAP autoSV ADV SYS ONE w/HT Humid, 60 Series, INT</tradeName>
    <deviceName></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>Artık piyasada değil</deviceStatus>
    <reference>IN961TS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:11.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029637</udiDi>
    <basicUdiDi>B-00606959029637</basicUdiDi>
    <tradeName>BiPAP autoSV ADV SYS ONE w/Humid, 60 Series INTL</tradeName>
    <deviceName></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>Artık piyasada değil</deviceStatus>
    <reference>IN961HS</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:09.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029620</udiDi>
    <basicUdiDi>B-00606959029620</basicUdiDi>
    <tradeName>BiPAP autoSV ADV SYS ONE 60 Series, INTL</tradeName>
    <deviceName></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>Artık piyasada değil</deviceStatus>
    <reference>IN961S</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:07.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029361</udiDi>
    <basicUdiDi>B-00606959029361</basicUdiDi>
    <tradeName>Heated Humidifier ES</tradeName>
    <deviceName></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>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ES6H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:05.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029323</udiDi>
    <basicUdiDi>B-00606959029323</basicUdiDi>
    <tradeName>System One Heated Humidifier GB</tradeName>
    <deviceName></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>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GB6H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:04.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029262</udiDi>
    <basicUdiDi>B-00606959029262</basicUdiDi>
    <tradeName>System One Heated Tube Humidfier GB</tradeName>
    <deviceName></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>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GB6T</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:03.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959029217</udiDi>
    <basicUdiDi>B-00606959029217</basicUdiDi>
    <tradeName>System One Heated Humidifier GER</tradeName>
    <deviceName></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>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DE6H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:05:00.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959028937</udiDi>
    <basicUdiDi>B-00606959028937</basicUdiDi>
    <tradeName>Recert-Trilogy 100 Vent,Germany -BT</tradeName>
    <deviceName>Trilogy 100, Trilogy EC</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>Artık piyasada değil</deviceStatus>
    <reference>U1054097B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:04:59.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959028920</udiDi>
    <basicUdiDi>B-00606959028920</basicUdiDi>
    <tradeName>Recert Trilogy 100 Ventilator,INTl - BT</tradeName>
    <deviceName>Trilogy 100, Trilogy EC</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>Artık piyasada değil</deviceStatus>
    <reference>U1054096B</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:04:58.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959028890</udiDi>
    <basicUdiDi>B-00606959028890</basicUdiDi>
    <tradeName>Trilogy 100 Ventilator,Germany-BT-RENT</tradeName>
    <deviceName>Trilogy 100, Trilogy EC</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>R1054097B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:04:56.830Z</lastUpdated>
  </row>
</eudamedExport>