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<eudamedExport entity="devices">
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    <udiDi>30606959000866</udiDi>
    <basicUdiDi>B-30606959000866</basicUdiDi>
    <tradeName>L Performax Su Intl W/Ee Leak 2 -10 Pack</tradeName>
    <deviceName>L Performax Su Intl W/Ee Leak 2 -10 Pack</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1052536</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:45:12.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959000859</udiDi>
    <basicUdiDi>B-30606959000859</basicUdiDi>
    <tradeName>S Performax Su Intl W/Ee Leak 2 -10 Pack</tradeName>
    <deviceName>S Performax Su Intl W/Ee Leak 2 -10 Pack</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1052535</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:45:11.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062511</udiDi>
    <basicUdiDi>B-00606959062511</basicUdiDi>
    <tradeName>Small/Medium, Large, Extra Large Pico Fitpack, with Headgear, Malaysia</tradeName>
    <deviceName>Small/Medium, Large, Extra Large Pico Fitpack, with Headgear, Malaysia</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1104940MY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:32.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062504</udiDi>
    <basicUdiDi>B-00606959062504</basicUdiDi>
    <tradeName>Extra Large Pico Nasal Mask with Headgear Malaysia</tradeName>
    <deviceName>Extra Large Pico Nasal Mask with Headgear Malaysia</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1104923MY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:31.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062498</udiDi>
    <basicUdiDi>B-00606959062498</basicUdiDi>
    <tradeName>Large Pico Nasal Mask with Headgear Malaysia</tradeName>
    <deviceName>Large Pico Nasal Mask with Headgear Malaysia</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1104922MY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:27.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062481</udiDi>
    <basicUdiDi>B-00606959062481</basicUdiDi>
    <tradeName>Small/Medium Pico Nasal Mask with Headgear Malaysia</tradeName>
    <deviceName>Small/Medium Pico Nasal Mask with Headgear Malaysia</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1104921MY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:26.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062443</udiDi>
    <basicUdiDi>B-00606959062443</basicUdiDi>
    <tradeName>Dreamwear Under the Nose/Silicone Pillows Frame Kit Large</tradeName>
    <deviceName>Dreamwear Under the Nose/Silicone Pillows Frame Kit Large</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1148934</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:25.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062436</udiDi>
    <basicUdiDi>B-00606959062436</basicUdiDi>
    <tradeName>Dreamwear Under the Nose/Silicone Pillows Frame Kit Medium</tradeName>
    <deviceName>Dreamwear Under the Nose/Silicone Pillows Frame Kit Medium</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1148933</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:25.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062429</udiDi>
    <basicUdiDi>B-00606959062429</basicUdiDi>
    <tradeName>Dreamwear Under the Nose/Silicone Pillows Frame Kit Small</tradeName>
    <deviceName>Dreamwear Under the Nose/Silicone Pillows Frame Kit Small</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1148932</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:21.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062153</udiDi>
    <basicUdiDi>B-00606959062153</basicUdiDi>
    <tradeName>DreamWear Silicone Pillows, FitPack Russian Corridor</tradeName>
    <deviceName>DreamWear Silicone Pillows, FitPack Russian Corridor</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146469RC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:20.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062146</udiDi>
    <basicUdiDi>B-00606959062146</basicUdiDi>
    <tradeName>DreamWear Silicone Pillows, FitPack Central Europe</tradeName>
    <deviceName>DreamWear Silicone Pillows, FitPack Central Europe</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146469CE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:19.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959062108</udiDi>
    <basicUdiDi>B-00606959062108</basicUdiDi>
    <tradeName>S, DreamWear Silicone Pillows, Small Frame with Headgear, Asain Pacific</tradeName>
    <deviceName>S, DreamWear Silicone Pillows, Small Frame with Headgear, Asain Pacific</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146410AP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:18.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959061088</udiDi>
    <basicUdiDi>B-00606959061088</basicUdiDi>
    <tradeName>MW, DreamWearFull, Sm and Med Frm, UK</tradeName>
    <deviceName>MW, DreamWearFull, Sm and Med Frm, UK</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1133373UA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:14.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959061071</udiDi>
    <basicUdiDi>B-00606959061071</basicUdiDi>
    <tradeName>L, DreamWear Full, Sm &amp; Med Frm, INTL</tradeName>
    <deviceName>L, DreamWear Full, Sm &amp; Med Frm, 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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1133372UA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:13.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060975</udiDi>
    <basicUdiDi>B-00606959060975</basicUdiDi>
    <tradeName>DreamWear SP, Demo Pack</tradeName>
    <deviceName>DreamWear SP, Demo Pack</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146471</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:13.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060968</udiDi>
    <basicUdiDi>B-00606959060968</basicUdiDi>
    <tradeName>DreamWear SP, Setup Pack</tradeName>
    <deviceName>DreamWear SP, Setup Pack</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146470</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:12.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060883</udiDi>
    <basicUdiDi>B-00606959060883</basicUdiDi>
    <tradeName>L, DreamWear SP, Lg Frm W/O HGR,GBL</tradeName>
    <deviceName>L, DreamWear SP, Lg Frm W/O HGR,GBL</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146463</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:08.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060944</udiDi>
    <basicUdiDi>B-00606959060944</basicUdiDi>
    <tradeName>DreamWear SP, FitPack, GBL</tradeName>
    <deviceName>DreamWear SP, FitPack, GBL</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146468</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:07.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060890</udiDi>
    <basicUdiDi>B-00606959060890</basicUdiDi>
    <tradeName>DreamWear Silicone Pillows MW, L Frame W/O Headgear, Global</tradeName>
    <deviceName>DreamWear Silicone Pillows MW, L Frame W/O Headgear, Global</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146464</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:29:06.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959060876</udiDi>
    <basicUdiDi>B-00606959060876</basicUdiDi>
    <tradeName>M, DreamWear SP, Lg Frm W/O HGR, GBL</tradeName>
    <deviceName>M, DreamWear SP, Lg Frm W/O HGR, GBL</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>R03010199</emdnCode>
    <emdnDescription>VENTILATION MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1146462</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:28:51.460Z</lastUpdated>
  </row>
</eudamedExport>