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<eudamedExport entity="devices">
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    <udiDi>00606959057890</udiDi>
    <basicUdiDi>B-00606959057890</basicUdiDi>
    <tradeName>A40 Pro/EFL, Sys One Heated Hum, Germany</tradeName>
    <deviceName>A40 Pro/EFL, Sys One Heated Hum, Germany</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>Piyasada</deviceStatus>
    <reference>DEX3H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:19:50.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959057869</udiDi>
    <basicUdiDi>B-00606959057869</basicUdiDi>
    <tradeName>A Series, System One, Heated Tube Humidifier, FR</tradeName>
    <deviceName>A Series, System One, Heated Tube Humidifier, 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR1111555</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:19:46.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959056862</udiDi>
    <basicUdiDi>B-00606959056862</basicUdiDi>
    <tradeName>A40 Pro/EFL, SysOne Htd Tube Hum, Intl</tradeName>
    <deviceName>A40 Pro/EFL, SysOne Htd Tube Hum, 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>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX3T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:19:45.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959056831</udiDi>
    <basicUdiDi>B-00606959056831</basicUdiDi>
    <tradeName>A40 Pro/EFL, Sys One Heated Hum, Intl</tradeName>
    <deviceName>A40 Pro/EFL, Sys One Heated Hum, 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>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INX3H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:19:44.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959048720</udiDi>
    <basicUdiDi>B-00606959048720</basicUdiDi>
    <tradeName>A Series System One Heated Humidifier, IT</tradeName>
    <deviceName>A Series System One Heated 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IT1111552</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:18:56.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959047099</udiDi>
    <basicUdiDi>B-00606959047099</basicUdiDi>
    <tradeName>Humid Air Outlet Port Disinfection Aid</tradeName>
    <deviceName>Humid Air Outlet Port Disinfection Aid</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>Piyasada</deviceStatus>
    <reference>1127627</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:18:52.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959042308</udiDi>
    <basicUdiDi>B-00606959042308</basicUdiDi>
    <tradeName>DreamStation Humidifier GB</tradeName>
    <deviceName>DreamStation 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>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:41.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959041035</udiDi>
    <basicUdiDi>B-00606959041035</basicUdiDi>
    <tradeName>A Series System One Heated Tube Humidifier, Japan</tradeName>
    <deviceName>A Series System One Heated Tube Humidifier, Japan</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>Piyasada</deviceStatus>
    <reference>1111556</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:36.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959039643</udiDi>
    <basicUdiDi>B-00606959039643</basicUdiDi>
    <tradeName>Silver Series Heated Humidifier</tradeName>
    <deviceName>Silver Series Heated Humidifier</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>Piyasada</deviceStatus>
    <reference>1120348</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:29.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959027640</udiDi>
    <basicUdiDi>B-00606959027640</basicUdiDi>
    <tradeName>DreamStation Humidifier Spain</tradeName>
    <deviceName>DreamStation Humidifier Spain</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>Piyasada</deviceStatus>
    <reference>ESXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:23.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959027589</udiDi>
    <basicUdiDi>B-00606959027589</basicUdiDi>
    <tradeName>DreamStation Humidifier EE</tradeName>
    <deviceName>DreamStation 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EEXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:21.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959027565</udiDi>
    <basicUdiDi>B-00606959027565</basicUdiDi>
    <tradeName>DreamStation Humidifier BL</tradeName>
    <deviceName>DreamStation 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:21.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959027220</udiDi>
    <basicUdiDi>B-00606959027220</basicUdiDi>
    <tradeName>DreamStation Humidifier ND</tradeName>
    <deviceName>DreamStation 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:16.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959024113</udiDi>
    <basicUdiDi>B-00606959024113</basicUdiDi>
    <tradeName>DreamStation Humidifier GER</tradeName>
    <deviceName>DreamStation Humidifier GER</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>Piyasada</deviceStatus>
    <reference>DEXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:08.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959023239</udiDi>
    <basicUdiDi>B-00606959023239</basicUdiDi>
    <tradeName>DreamStation Humidifier, EU</tradeName>
    <deviceName>DreamStation 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EUXH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:10:04.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021556</udiDi>
    <basicUdiDi>B-00606959021556</basicUdiDi>
    <tradeName>A Series System One Heated Humidifier, INTL</tradeName>
    <deviceName>A Series System One Heated 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>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1111552</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:09:57.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959013872</udiDi>
    <basicUdiDi>B-00606959013872</basicUdiDi>
    <tradeName>A Series Humidifer, INTL</tradeName>
    <deviceName>A Series Humidifer, 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>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1077107</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:09:24.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>16923980105712</udiDi>
    <basicUdiDi>69239801ND2FANV</basicUdiDi>
    <tradeName>Aplus Humidification Chamber</tradeName>
    <deviceName>Disposable Humidification Chamber</deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060280</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XJK0001</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-19T07:37:25.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060120950352</udiDi>
    <basicUdiDi>506012095Cat47B</basicUdiDi>
    <tradeName>Insufflation Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GVS Filter Technology UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045036</manufacturerSrn>
    <authorisedRepresentativeName>GVS S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028148</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000/05DWKBIUA121/0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:08.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060120950383</udiDi>
    <basicUdiDi>506012095Cat47B</basicUdiDi>
    <tradeName>Insufflation Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GVS Filter Technology UK Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000045036</manufacturerSrn>
    <authorisedRepresentativeName>GVS S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000028148</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R060299</emdnCode>
    <emdnDescription>HUMIDIFICATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2200/25BUKBAUA001/0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:08.127Z</lastUpdated>
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</eudamedExport>