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<eudamedExport entity="devices">
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    <udiDi>00606959004702</udiDi>
    <basicUdiDi>B-00606959004702</basicUdiDi>
    <tradeName>6FT (1.83M) System One Performance Tubing - 15</tradeName>
    <deviceName>6FT (1.83M) System One Performance Tubing - 15</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>1074400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:47:17.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959002593</udiDi>
    <basicUdiDi>B-00606959002593</basicUdiDi>
    <tradeName>O2 Enrichment Attachment, Qty: 10</tradeName>
    <deviceName>O2 Enrichment Attachment, Qty: 10</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>312010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:47:17.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959002173</udiDi>
    <basicUdiDi>B-00606959002173</basicUdiDi>
    <tradeName>Performance Tubing, 6’ (1.83 M) White</tradeName>
    <deviceName>Performance Tubing, 6’ (1.83 M) White</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>1032907</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:47:16.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959002166</udiDi>
    <basicUdiDi>B-00606959002166</basicUdiDi>
    <tradeName>Reusable Flexible Tubing, 6 ft (1.83m), Grey</tradeName>
    <deviceName>Reusable Flexible Tubing, 6 ft (1.83m), Grey</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>622038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:47:15.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012436139</udiDi>
    <basicUdiDi>94200124NIV01DJ</basicUdiDi>
    <tradeName>F&amp;P NIVAIRO</tradeName>
    <deviceName>NIV Mask</deviceName>
    <manufacturerName>Fisher &amp; Paykel Healthcare Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000002556</manufacturerSrn>
    <authorisedRepresentativeName>FISHER &amp; PAYKEL HEALTHCARE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000294</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0301010202</emdnCode>
    <emdnDescription>NIV MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT045L</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T00:59:17.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959048097</udiDi>
    <basicUdiDi>B-30606959048097</basicUdiDi>
    <tradeName>AF531 Mask w/SE, w/Reduced Size 4 PT Headgear, SU, Medium</tradeName>
    <deviceName>AF531 Mask w/SE, w/Reduced Size 4 PT Headgear, SU, 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>1134715</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:45.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959042453</udiDi>
    <basicUdiDi>B-30606959042453</basicUdiDi>
    <tradeName>Philips Procedure 5 Pack, PerforMax SU W/FEP, S</tradeName>
    <deviceName>Philips Procedure 5 Pack, PerforMax SU W/FEP, S</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>1074063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:45.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959042446</udiDi>
    <basicUdiDi>B-30606959042446</basicUdiDi>
    <tradeName>Philips Procedure 5 Pack, PerforMax SU W/FEP, L</tradeName>
    <deviceName>Philips Procedure 5 Pack, PerforMax SU W/FEP, L</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>1074062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:43.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959041753</udiDi>
    <basicUdiDi>B-30606959041753</basicUdiDi>
    <tradeName>PN841, INTL, Child Small, SE, 5 Pack</tradeName>
    <deviceName>PN841, INTL, Child Small, SE, 5 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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1130582</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:41.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959041777</udiDi>
    <basicUdiDi>B-30606959041777</basicUdiDi>
    <tradeName>PN841, INTL, Child Large, SE, 5 Pack</tradeName>
    <deviceName>PN841, INTL, Child Large, SE, 5 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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1130584</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:39.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959041760</udiDi>
    <basicUdiDi>B-30606959041760</basicUdiDi>
    <tradeName>PN841, INTL, Child Med, SE, 5 Pack</tradeName>
    <deviceName>PN841, INTL, Child Med, SE, 5 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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1130583</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:38.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959041746</udiDi>
    <basicUdiDi>B-30606959041746</basicUdiDi>
    <tradeName>PN841, INTL, Child Large, Leak 3, 5 Pack</tradeName>
    <deviceName>PN841, INTL, Child Large, Leak 3, 5 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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1130581</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:37.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959041739</udiDi>
    <basicUdiDi>B-30606959041739</basicUdiDi>
    <tradeName>PN841, INTL, Child Med, Leak 3, 5 Pack</tradeName>
    <deviceName>PN841, INTL, Child Med, Leak 3, 5 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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1130580</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:21.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959041722</udiDi>
    <basicUdiDi>B-30606959041722</basicUdiDi>
    <tradeName>PN841, INTL, Child Small, Leak 3, 5 Pack</tradeName>
    <deviceName>PN841, INTL, Child Small, Leak 3, 5 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>R0301010201</emdnCode>
    <emdnDescription>CPAP MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1130579</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:20.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012470</udiDi>
    <basicUdiDi>B-30606959012470</basicUdiDi>
    <tradeName>ACC, PerforMax Ped EE Leak 1 Elbow, 5 Pack</tradeName>
    <deviceName>ACC, PerforMax Ped EE Leak 1 Elbow, 5 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>1100688</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:07.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012425</udiDi>
    <basicUdiDi>B-30606959012425</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 2, with 4 PT Headgear, Large, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 2, with 4 PT Headgear, Large, SU</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>1100395</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:03.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012418</udiDi>
    <basicUdiDi>B-30606959012418</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 2, with 4 PT Headgear, Medium, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 2, with 4 PT Headgear, Medium, SU</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>1100394</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:01.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012401</udiDi>
    <basicUdiDi>B-30606959012401</basicUdiDi>
    <tradeName>AF531 Mask EE, Leak 2, with 4 PT Headgear, Small, SU</tradeName>
    <deviceName>AF531 Mask EE, Leak 2, with 4 PT Headgear, Small, SU</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>1100393</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:00.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012128</udiDi>
    <basicUdiDi>B-30606959012128</basicUdiDi>
    <tradeName>AF531 Mask w/SE, and CapStrap, Large, Single Use</tradeName>
    <deviceName>AF531 Mask w/SE, and CapStrap, Large, Single Use</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>1072632</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:00.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959012111</udiDi>
    <basicUdiDi>B-30606959012111</basicUdiDi>
    <tradeName>AF531 Mask w/SE, and CapStrap, Medium, Single Use</tradeName>
    <deviceName>AF531 Mask w/SE, and CapStrap, Medium, Single Use</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>1072631</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:47:56.123Z</lastUpdated>
  </row>
</eudamedExport>