<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00606959054110</udiDi>
    <basicUdiDi>B-00606959054110</basicUdiDi>
    <tradeName>Trilogy Evo, Germany</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>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE2110X13B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:10:10.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959054103</udiDi>
    <basicUdiDi>B-00606959054103</basicUdiDi>
    <tradeName>Trilogy Evo O2, Germany</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>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE2100X13B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:10:08.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959054097</udiDi>
    <basicUdiDi>B-00606959054097</basicUdiDi>
    <tradeName>Trilogy Evo O2, Iberia</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>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES2100X15B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:10:07.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959054080</udiDi>
    <basicUdiDi>B-00606959054080</basicUdiDi>
    <tradeName>Trilogy Evo, Iberia</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>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES2110X15B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:10:06.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959054059</udiDi>
    <basicUdiDi>B-00606959054059</basicUdiDi>
    <tradeName>Trilogy Evo, O2, International</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>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN2100X15B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:10:03.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959051966</udiDi>
    <basicUdiDi>B-00606959051966</basicUdiDi>
    <tradeName>Trilogy Evo, International (Non-BT)</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>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN2110X19</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:10:01.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959051959</udiDi>
    <basicUdiDi>B-00606959051959</basicUdiDi>
    <tradeName>Trilogy Evo, International</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>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN2110X15B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:09:59.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959042315</udiDi>
    <basicUdiDi>B-00606959042315</basicUdiDi>
    <tradeName>FEP Circuit S/A w/Filter – 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1065834</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:54.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959026506</udiDi>
    <basicUdiDi>B-00606959026506</basicUdiDi>
    <tradeName>Trilogy 200 Ventilator Germany Bluetooth</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>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1032802B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:04:02.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959002616</udiDi>
    <basicUdiDi>B-00606959002616</basicUdiDi>
    <tradeName>(10) BiPAP Disposable Humidifier Tubing 36 IN (91cm)</tradeName>
    <deviceName>BiPAP Disp Circuits</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>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>312111</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:00:57.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809268914294</udiDi>
    <basicUdiDi>880926891Z12030104H3N</basicUdiDi>
    <tradeName>HFT750</tradeName>
    <deviceName>HFT750</deviceName>
    <manufacturerName>MEKICS Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000012640</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCN-WM-1875</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:49:30.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698898250045</udiDi>
    <basicUdiDi>869889825SIP00475</basicUdiDi>
    <tradeName>Peep Valfli Otomatik Resüsitatör HMEF Filtreli</tradeName>
    <deviceName>Peep Valfli Otomatik Resüsitatör HMEF Filtreli</deviceName>
    <manufacturerName>Yiğit Sağlık Araç ve Gereçleri Paz. İth. İhr. Ltd. Şti</manufacturerName>
    <manufacturerSrn>TR-PR-000051597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIP004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:53:28.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698898250038</udiDi>
    <basicUdiDi>869889825SIP00373</basicUdiDi>
    <tradeName>Otomatik Resüsitatör HMEF Filtreli</tradeName>
    <deviceName>Otomatik Resüsitatör HMEF Filtreli</deviceName>
    <manufacturerName>Yiğit Sağlık Araç ve Gereçleri Paz. İth. İhr. Ltd. Şti</manufacturerName>
    <manufacturerSrn>TR-PR-000051597</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIP003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:53:27.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680829050077</udiDi>
    <basicUdiDi>8680829050077AK</basicUdiDi>
    <tradeName>Oxi-Life</tradeName>
    <deviceName>Portable Mechanical Ventilator</deviceName>
    <manufacturerName>Modül Grup Mühendislik Elektr.Med.İnş.Eğt.ve Bilş.San.Tic.Ltd.Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000050023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Oxi-Life</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:22:05.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033737260425</udiDi>
    <basicUdiDi>80337372604PV</basicUdiDi>
    <tradeName>SIRIO S2/T</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siare Enginnering International Group S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025581</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09436</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:11:17.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974213416597</udiDi>
    <basicUdiDi>697421341S9930T7S</basicUdiDi>
    <tradeName>06974213416597</tradeName>
    <deviceName>Sleep Apnea Ventilator</deviceName>
    <manufacturerName>Nanjing Superstar Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020034</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S9930T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:40:11.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974213416559</udiDi>
    <basicUdiDi>697421341S913096</basicUdiDi>
    <tradeName>06974213416559</tradeName>
    <deviceName>Sleep Apnea Ventilator</deviceName>
    <manufacturerName>Nanjing Superstar Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020034</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S9130</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:40:11.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974213416535</udiDi>
    <basicUdiDi>697421341S90308Z</basicUdiDi>
    <tradeName>06974213416535</tradeName>
    <deviceName>Sleep Apnea Ventilator</deviceName>
    <manufacturerName>Nanjing Superstar Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020034</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S9030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:40:07.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972733991938</udiDi>
    <basicUdiDi>697273399120301PVSIJG</basicUdiDi>
    <tradeName>Ventilator</tradeName>
    <deviceName>Ventilator</deviceName>
    <manufacturerName>HEYER Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014712</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112000324</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:08:57.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>04054685276522</udiDi>
    <basicUdiDi>40546851012MN</basicUdiDi>
    <tradeName>MEDUVENT Standard</tradeName>
    <deviceName>MEDUVENT Standard ventilator</deviceName>
    <manufacturerName>WEINMANN Emergency Medical Technology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WM 35720</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:24:28.553Z</lastUpdated>
  </row>
</eudamedExport>