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<eudamedExport entity="devices">
  <row>
    <udiDi>00606959023079</udiDi>
    <basicUdiDi>B-00606959023079</basicUdiDi>
    <tradeName>FitLife Mask with SE, with Headgear, XLarge, INTL</tradeName>
    <deviceName>FitLife Family</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>1089995</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:38.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959023055</udiDi>
    <basicUdiDi>B-00606959023055</basicUdiDi>
    <tradeName>FitLife Mask with Headgear, w/SE, Small, INTL</tradeName>
    <deviceName>FitLife Family</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>1061711</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:23.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959022751</udiDi>
    <basicUdiDi>B-00606959022751</basicUdiDi>
    <tradeName>Trilogy100 Ventilator, Germany</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>1054097</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:22.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959022720</udiDi>
    <basicUdiDi>B-00606959022720</basicUdiDi>
    <tradeName>Trilogy 202 Ventilator Germany</tradeName>
    <deviceName>Trilogy 202/O2</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>1040003</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:20.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959022713</udiDi>
    <basicUdiDi>B-00606959022713</basicUdiDi>
    <tradeName>Garbin Plus Ventilator, 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1040002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:18.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959022706</udiDi>
    <basicUdiDi>B-00606959022706</basicUdiDi>
    <tradeName>Trilogy 202 Ventilator International</tradeName>
    <deviceName>Trilogy 202/O2</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>1040000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:16.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959022690</udiDi>
    <basicUdiDi>B-00606959022690</basicUdiDi>
    <tradeName>Trilogy 200 Ventilator, 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>Z12030103</emdnCode>
    <emdnDescription>PULMONARY VENTILATORS FOR NON–HOSPITAL USE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1032802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:15.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959022669</udiDi>
    <basicUdiDi>B-00606959022669</basicUdiDi>
    <tradeName>Garbin Ventilator, DE</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>1040001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:14.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959022249</udiDi>
    <basicUdiDi>B-00606959022249</basicUdiDi>
    <tradeName>M COMFORTGEL BLUE SE NASAL MASK W/HGR, 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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1070069</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:11.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021914</udiDi>
    <basicUdiDi>B-00606959021914</basicUdiDi>
    <tradeName>Humidifier Oxigen Salud</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>XS6H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:10.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021907</udiDi>
    <basicUdiDi>B-00606959021907</basicUdiDi>
    <tradeName>Dorma 100, Oxigen Salud</tradeName>
    <deviceName>REMstar, REMstar SE, Dorma</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>Z1203010502</emdnCode>
    <emdnDescription>ADULT PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>XSV101</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:09.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021471</udiDi>
    <basicUdiDi>B-00606959021471</basicUdiDi>
    <tradeName>NUANCE PRO GEL PILLOWS MASK W/HGR, 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>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1105168</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:07.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021457</udiDi>
    <basicUdiDi>B-00606959021457</basicUdiDi>
    <tradeName>Actiware Software CD - 6</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</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>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1104775</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:05.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021402</udiDi>
    <basicUdiDi>B-00606959021402</basicUdiDi>
    <tradeName>Actiwatch Spectrum PRO</tradeName>
    <deviceName>Actiwatch Spectrum Pro and Actiwatch Spe</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>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1099351</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:03.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021372</udiDi>
    <basicUdiDi>B-00606959021372</basicUdiDi>
    <tradeName>CoughAssist 70 Series Circuit, Mouthpiece, 9ft</tradeName>
    <deviceName>CoughAssist Class IIa Accessories</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>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1098410</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:03.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021365</udiDi>
    <basicUdiDi>B-00606959021365</basicUdiDi>
    <tradeName>CoughAssist 70 Series Circuit, Adult Large, 9ft</tradeName>
    <deviceName>CoughAssist Class IIa Accessories</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>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1098408</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:03:01.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021358</udiDi>
    <basicUdiDi>B-00606959021358</basicUdiDi>
    <tradeName>CoughAssist 70 Series Circuit, Adult Medium, 9ft</tradeName>
    <deviceName>CoughAssist Class IIa Accessories</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>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1098407</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:59.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021341</udiDi>
    <basicUdiDi>B-00606959021341</basicUdiDi>
    <tradeName>CoughAssist 70 Series Circuit, Adult Small, 9ft</tradeName>
    <deviceName>CoughAssist Class IIa Accessories</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>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1098405</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:57.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021334</udiDi>
    <basicUdiDi>B-00606959021334</basicUdiDi>
    <tradeName>CoughAssist 70 Series Circuit, Toddler, 9ft</tradeName>
    <deviceName>CoughAssist Class IIa Accessories</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>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1098404</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:56.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959021327</udiDi>
    <basicUdiDi>B-00606959021327</basicUdiDi>
    <tradeName>CoughAssist 70 Series Circuit, Infant, 9ft.</tradeName>
    <deviceName>CoughAssist Class IIa Accessories</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>R05010301</emdnCode>
    <emdnDescription>SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1098403</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:55.017Z</lastUpdated>
  </row>
</eudamedExport>