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<eudamedExport entity="devices">
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    <basicUdiDi>B-00606959014992</basicUdiDi>
    <tradeName>AMARA MASK WITH RS FRAME AND HEADGEAR LARGE, INTL</tradeName>
    <deviceName>Amara, Amara Gel 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>1090228</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:02:00.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959014985</udiDi>
    <basicUdiDi>B-00606959014985</basicUdiDi>
    <tradeName>AMARA MASK W/ RS FRAME AND HEADGEAR, MEDIUM, INTL</tradeName>
    <deviceName>Amara, Amara Gel 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>1090225</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:58.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959014978</udiDi>
    <basicUdiDi>B-00606959014978</basicUdiDi>
    <tradeName>AMARA MASK W/ RS FRAME AND RS HEADGEAR, SMALL, INTL</tradeName>
    <deviceName>Amara, Amara Gel 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>1090221</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:56.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009264</udiDi>
    <basicUdiDi>B-00606959009264</basicUdiDi>
    <tradeName>Amara View Mask with Headgear, Medium, INTL</tradeName>
    <deviceName>Amara View Minimal Contact</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>1090663</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:37.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009189</udiDi>
    <basicUdiDi>B-00606959009189</basicUdiDi>
    <tradeName>Amara View Mask without Headgear, Large</tradeName>
    <deviceName>Amara View Minimal Contact</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>1090614</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:21.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009172</udiDi>
    <basicUdiDi>B-00606959009172</basicUdiDi>
    <tradeName>Amara View Mask without Headgear, Medium</tradeName>
    <deviceName>Amara View Minimal Contact</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>1090613</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:20.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959009165</udiDi>
    <basicUdiDi>B-00606959009165</basicUdiDi>
    <tradeName>Amara View Mask without Headgear, Small</tradeName>
    <deviceName>Amara View Minimal Contact</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>1090612</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:18.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959008007</udiDi>
    <basicUdiDi>B-00606959008007</basicUdiDi>
    <tradeName>S PerforMax MPU INTL w/EE Leak 2 &amp; SE, Plus 4 HG</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>1052553</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:01:16.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959001800</udiDi>
    <basicUdiDi>B-00606959001800</basicUdiDi>
    <tradeName>L FITLIFE MASK EE W/HGR INT</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>1060804</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:00:55.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959001794</udiDi>
    <basicUdiDi>B-00606959001794</basicUdiDi>
    <tradeName>S FITLIFE MASK EE W/HGR INT</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>1060803</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:00:54.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959001602</udiDi>
    <basicUdiDi>B-00606959001602</basicUdiDi>
    <tradeName>ComfortGel Blue Nasal Mask w/Headgear, Petite, INTL</tradeName>
    <deviceName>ComfortGel Blue / ProFile Lite 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>Artık piyasada değil</deviceStatus>
    <reference>1070067</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:00:53.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959001596</udiDi>
    <basicUdiDi>B-00606959001596</basicUdiDi>
    <tradeName>ComfortGel Blue Nasal Mask w/Headgear, Small, INTL</tradeName>
    <deviceName>ComfortGel Blue / ProFile Lite 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>Artık piyasada değil</deviceStatus>
    <reference>1070066</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:00:50.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959001589</udiDi>
    <basicUdiDi>B-00606959001589</basicUdiDi>
    <tradeName>ComfortGel Blue Nasal Mask w/Headgear, Medium, INTL</tradeName>
    <deviceName>ComfortGel Blue / ProFile Lite 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>Artık piyasada değil</deviceStatus>
    <reference>1070065</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:00:49.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959001572</udiDi>
    <basicUdiDi>B-00606959001572</basicUdiDi>
    <tradeName>ComfortGel Blue Nasal Mask w/Headgear, Large, INTL</tradeName>
    <deviceName>ComfortGel Blue / ProFile Lite 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>Artık piyasada değil</deviceStatus>
    <reference>1070064</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:00:48.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680845006027</udiDi>
    <basicUdiDi>868407208MASKM3</basicUdiDi>
    <tradeName>NAZAL (BURUN) MASKE SİLİKON ESASLI SMALL</tradeName>
    <deviceName>Continuous Positive Airway Pressure Device</deviceName>
    <manufacturerName>Ece Tıbbi Cihazlar ve Medikal San. Tic. A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000017200</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RN01S</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:22:38.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058323040984</udiDi>
    <basicUdiDi>80583230DCSMASKLN</basicUdiDi>
    <tradeName>08058323040984</tradeName>
    <deviceName>MASK FOR NIV - SINGLE PATIENT AND ACCESSORIES</deviceName>
    <manufacturerName>Intersurgical SpA</manufacturerName>
    <manufacturerSrn>IT-MF-000010729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMASK-004PED</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:02:51.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058323015777</udiDi>
    <basicUdiDi>80583230DCSMASKRVE</basicUdiDi>
    <tradeName>08058323015777</tradeName>
    <deviceName>MASK FOR NIV REUSABLE AND ACCESSORIES</deviceName>
    <manufacturerName>Intersurgical SpA</manufacturerName>
    <manufacturerSrn>IT-MF-000010729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MASKR-0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:02:35.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>08015662727419</udiDi>
    <basicUdiDi>8015662INSOFTCHILDNV2S</basicUdiDi>
    <tradeName>Ineva SOFT Child Non Vented</tradeName>
    <deviceName>Ineva SOFT Child Non Vented</deviceName>
    <manufacturerName>Air Liquide Medical Systems S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000015627</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>472741</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:26:24.006Z</lastUpdated>
  </row>
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    <udiDi>08015662727372</udiDi>
    <basicUdiDi>8015662INSOFTBABYNVWZ</basicUdiDi>
    <tradeName>Ineva SOFT Baby Non Vented</tradeName>
    <deviceName>Ineva SOFT Baby Non Vented</deviceName>
    <manufacturerName>Air Liquide Medical Systems S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000015627</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>472737</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:26:20.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>08015662727334</udiDi>
    <basicUdiDi>8015662ALSOFTCHILDNVN5</basicUdiDi>
    <tradeName>Alnest SOFT Child Non Vented</tradeName>
    <deviceName>Alnest SOFT Child Non Vented</deviceName>
    <manufacturerName>Air Liquide Medical Systems S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000015627</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>472733</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:26:17.602Z</lastUpdated>
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</eudamedExport>