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<eudamedExport entity="devices">
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    <udiDi>00690103197129</udiDi>
    <basicUdiDi>0690103D001TDT000WX</basicUdiDi>
    <tradeName>TRUWAVE, VAMP PLUS</tradeName>
    <deviceName>TruWave Disposable Pressure Transducer and Pressure Monitoring Set/Kit</deviceName>
    <manufacturerName>Edwards Lifesciences LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007139</manufacturerSrn>
    <authorisedRepresentativeName>Edwards Lifesciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006184</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020301</emdnCode>
    <emdnDescription>INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T490007A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:03:51.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690103220193</udiDi>
    <basicUdiDi>0690103D001TDT000WX</basicUdiDi>
    <tradeName>TRUWAVE, VAMP FLEX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Edwards Lifesciences LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007139</manufacturerSrn>
    <authorisedRepresentativeName>Edwards Lifesciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006184</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020301</emdnCode>
    <emdnDescription>INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T311058A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:00:31.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690103192773</udiDi>
    <basicUdiDi>0690103D003CRI000TH</basicUdiDi>
    <tradeName>CRIMPER</tradeName>
    <deviceName>CRIMPER</deviceName>
    <manufacturerName>Edwards Lifesciences LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007139</manufacturerSrn>
    <authorisedRepresentativeName>Edwards Lifesciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006184</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P07038002</emdnCode>
    <emdnDescription>CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9600CR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:22:14.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690103210927</udiDi>
    <basicUdiDi>0690103D001HAM000PH</basicUdiDi>
    <tradeName>FORESIGHT OXIMETER CABLE</tradeName>
    <deviceName>HemoSphere Advanced Monitoring Platform</deviceName>
    <manufacturerName>Edwards Lifesciences LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007139</manufacturerSrn>
    <authorisedRepresentativeName>Edwards Lifesciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006184</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020280</emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEMFSM10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:40:03.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690103221251</udiDi>
    <basicUdiDi>0690103D001VCS000X7</basicUdiDi>
    <tradeName>VolumeView</tradeName>
    <deviceName>VolumeView Catheter Sets</deviceName>
    <manufacturerName>Edwards Lifesciences LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007139</manufacturerSrn>
    <authorisedRepresentativeName>Edwards Lifesciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006184</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPTD4F1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-04T17:55:53.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690103221268</udiDi>
    <basicUdiDi>0690103D001VCS000X7</basicUdiDi>
    <tradeName>VolumeView</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Edwards Lifesciences LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007139</manufacturerSrn>
    <authorisedRepresentativeName>Edwards Lifesciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006184</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPTD5F1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T19:55:05.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690103221275</udiDi>
    <basicUdiDi>0690103D001VCS000X7</basicUdiDi>
    <tradeName>VolumeView</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Edwards Lifesciences LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007139</manufacturerSrn>
    <authorisedRepresentativeName>Edwards Lifesciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006184</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPTD4F5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T19:54:44.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690103221282</udiDi>
    <basicUdiDi>0690103D001VCS000X7</basicUdiDi>
    <tradeName>VolumeView</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Edwards Lifesciences LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007139</manufacturerSrn>
    <authorisedRepresentativeName>Edwards Lifesciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006184</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPTD5F5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T19:54:42.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690103197143</udiDi>
    <basicUdiDi>0690103D001CS1000MR</basicUdiDi>
    <tradeName>CO-SET+</tradeName>
    <deviceName>Co-Set</deviceName>
    <manufacturerName>Edwards Lifesciences LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007139</manufacturerSrn>
    <authorisedRepresentativeName>Edwards Lifesciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006184</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030299</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93524</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:13:31.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>00690103197167</udiDi>
    <basicUdiDi>0690103D001CS1000MR</basicUdiDi>
    <tradeName>CO-SET+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Edwards Lifesciences LLC</manufacturerName>
    <manufacturerSrn>US-MF-000007139</manufacturerSrn>
    <authorisedRepresentativeName>Edwards Lifesciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006184</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030299</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93528</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T14:00:10.360Z</lastUpdated>
  </row>
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