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<eudamedExport entity="devices">
  <row>
    <udiDi>09420012432025</udiDi>
    <basicUdiDi>B-09420012432025</basicUdiDi>
    <tradeName>F&amp;P 850</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MR290V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T12:29:10.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012432247</udiDi>
    <basicUdiDi>B-09420012432247</basicUdiDi>
    <tradeName>CIRCUIT</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900MR810</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T12:29:10.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012432292</udiDi>
    <basicUdiDi>B-09420012432292</basicUdiDi>
    <tradeName>F&amp;P OPTIFLOW JUNIOR</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPT316</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T12:29:10.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012461452</udiDi>
    <basicUdiDi>94200124OJRCANEC</basicUdiDi>
    <tradeName>F&amp;P OPTIFLOW JUNIOR 2</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OJR418HM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T12:29:10.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012469298</udiDi>
    <basicUdiDi>94200124AIRVO3HH02ES</basicUdiDi>
    <tradeName>F&amp;P AIRVO 3</tradeName>
    <deviceName>Respiratory Support Device</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PT301UK</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:09:19.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012455420</udiDi>
    <basicUdiDi>94200124950RHH001S6</basicUdiDi>
    <tradeName>F&amp;P 950</tradeName>
    <deviceName>Respiratory Humidifier</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>950AEU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:09:18.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012454560</udiDi>
    <basicUdiDi>94200124950NCOHK1WD</basicUdiDi>
    <tradeName>F&amp;P 950</tradeName>
    <deviceName>Heated Circuit</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>R02010199</emdnCode>
    <emdnDescription>STANDARD BREATHING CIRCUITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>950N40</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:09:17.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012436825</udiDi>
    <basicUdiDi>94200124950AVDHK1V8</basicUdiDi>
    <tradeName>F&amp;P 950</tradeName>
    <deviceName>Breathing Circuit</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>R02010199</emdnCode>
    <emdnDescription>STANDARD BREATHING CIRCUITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>950A81</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:09:13.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012435743</udiDi>
    <basicUdiDi>94200124OJRCANEC</basicUdiDi>
    <tradeName>F&amp;P OPTIFLOW JUNIOR 2</tradeName>
    <deviceName>Nasal Cannula</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>R0301020302</emdnCode>
    <emdnDescription>HIGH FLOW THERAPY NASAL CANNULAS (HFNC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OJR410</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:09:12.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012429117</udiDi>
    <basicUdiDi>94200124RACOPTINT8F</basicUdiDi>
    <tradeName>F&amp;P OPTIFLOW+</tradeName>
    <deviceName>Nasal Cannula</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>R0301020302</emdnCode>
    <emdnDescription>HIGH FLOW THERAPY NASAL CANNULAS (HFNC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPT944</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:09:12.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012410931</udiDi>
    <basicUdiDi>94200124NEOPUFIFRSAD2QL</basicUdiDi>
    <tradeName>F&amp;P NEOPUFF</tradeName>
    <deviceName>T- Piece Resuscitator</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD900AEU</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:09:11.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012432469</udiDi>
    <basicUdiDi>B-09420012432469</basicUdiDi>
    <tradeName>F&amp;P FLEXITRUNK</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC191-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:18:11.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012410948</udiDi>
    <basicUdiDi>B-09420012410948</basicUdiDi>
    <tradeName>F&amp;P NEOPUFF</tradeName>
    <deviceName></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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD900AFU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:30:57.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012429155</udiDi>
    <basicUdiDi>94200124RACOPTINT8F</basicUdiDi>
    <tradeName>F&amp;P OPTIFLOW+</tradeName>
    <deviceName></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>R0301020302</emdnCode>
    <emdnDescription>HIGH FLOW THERAPY NASAL CANNULAS (HFNC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPT946</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:30:57.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012430205</udiDi>
    <basicUdiDi>B-09420012430205</basicUdiDi>
    <tradeName>F&amp;P EVAQUA 2</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT265</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:30:57.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012431103</udiDi>
    <basicUdiDi>B-09420012431103</basicUdiDi>
    <tradeName>F&amp;P EVAQUA 2</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT266</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:30:57.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012432254</udiDi>
    <basicUdiDi>B-09420012432254</basicUdiDi>
    <tradeName>Circuit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900MR810E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:30:57.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012432285</udiDi>
    <basicUdiDi>B-09420012432285</basicUdiDi>
    <tradeName>F&amp;P OPTIFLOW JUNIOR</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPT314</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:30:57.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012433794</udiDi>
    <basicUdiDi>B-09420012433794</basicUdiDi>
    <tradeName>F&amp;P AIRVO</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900PT561</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:30:57.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>09420012447517</udiDi>
    <basicUdiDi>B-09420012447517</basicUdiDi>
    <tradeName>F&amp;P AIRVO</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900PT562</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:30:57.712Z</lastUpdated>
  </row>
</eudamedExport>