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<eudamedExport entity="devices">
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    <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>40606959032369</udiDi>
    <basicUdiDi>B-40606959032369</basicUdiDi>
    <tradeName>Cannula, PF Nasal M-F 0.20x0.35 10PK</tradeName>
    <deviceName>Cannula, PF Nasal M-F 0.20x0.35 10PK</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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1097349</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:51.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>40606959032352</udiDi>
    <basicUdiDi>B-40606959032352</basicUdiDi>
    <tradeName>Cannula, PF Nasal M-F 0.35x0.35 10PK</tradeName>
    <deviceName>Cannula, PF Nasal M-F 0.35x0.35 10PK</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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1097348</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:49.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>40606959032321</udiDi>
    <basicUdiDi>B-40606959032321</basicUdiDi>
    <tradeName>Pro-Flow MultiPurpose Cann Adult 5PK</tradeName>
    <deviceName>Pro-Flow MultiPurpose Cann Adult 5PK</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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1368</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:47.424Z</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>30606959032379</udiDi>
    <basicUdiDi>B-30606959032379</basicUdiDi>
    <tradeName>Cannula, PF Nasal M-F 0.45x0.40 10PK</tradeName>
    <deviceName>Cannula, PF Nasal M-F 0.45x0.40 10PK</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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1097345</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:20.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959032362</udiDi>
    <basicUdiDi>B-30606959032362</basicUdiDi>
    <tradeName>Cannula, PF Nasal M-F 0.20x0.35 60PK</tradeName>
    <deviceName>Cannula, PF Nasal M-F 0.20x0.35 60PK</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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1097940</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:16.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959032355</udiDi>
    <basicUdiDi>B-30606959032355</basicUdiDi>
    <tradeName>Cannula, PF Nasal M-F 0.35x0.35 60PK</tradeName>
    <deviceName>Cannula, PF Nasal M-F 0.35x0.35 60PK</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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1097939</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:15.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959032348</udiDi>
    <basicUdiDi>B-30606959032348</basicUdiDi>
    <tradeName>PF+MultiPurpose Cannula Adult 30/CS</tradeName>
    <deviceName>PF+MultiPurpose Cannula Adult 30/CS</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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1373</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:14.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959032331</udiDi>
    <basicUdiDi>B-30606959032331</basicUdiDi>
    <tradeName>PF+MulitPurpose Cann PED 30/CS</tradeName>
    <deviceName>PF+MulitPurpose Cann PED 30/CS</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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1366</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:13.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959032324</udiDi>
    <basicUdiDi>B-30606959032324</basicUdiDi>
    <tradeName>Pro-Flow MultiPurpose Can Adult 30/CS</tradeName>
    <deviceName>Pro-Flow MultiPurpose Can Adult 30/CS</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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1350</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:09.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959032317</udiDi>
    <basicUdiDi>B-30606959032317</basicUdiDi>
    <tradeName>Pro-Flow MultiPurpose Can Ped Sm 30/CS</tradeName>
    <deviceName>Pro-Flow MultiPurpose Can Ped Sm 30/CS</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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1348</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:48:08.943Z</lastUpdated>
  </row>
</eudamedExport>