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<eudamedExport entity="devices">
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    <udiDi>09353278000229</udiDi>
    <basicUdiDi>93532780AIStation2U3</basicUdiDi>
    <tradeName>AI Station 2</tradeName>
    <deviceName>Kosmos Class I Accessories</deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P006200</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:23.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000120</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos Bridge</tradeName>
    <deviceName>Kosmos</deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P006030</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:23.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000137</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos Torso</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P006025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000212</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos Binaural Headset</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P006115</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000243</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos ECG Patient Cable – International</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P006186</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000250</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos Accessories-International</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P006105</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000410</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos Torso-One</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P006440</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000434</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos Torso-One (Refurbished)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R006440</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000441</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos Torso (Refurbished)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R006025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000458</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos Bridge (Refurbished)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R006030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000502</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos Torso-One – USB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P006632</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000519</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos Lexsa</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P006709</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000571</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos Torso-One – USB (Refurbished)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R006632</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000588</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos Software [Android]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P006576</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000595</udiDi>
    <basicUdiDi>93532780AIStation2U3</basicUdiDi>
    <tradeName>Kosmos Hub</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P006966</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000618</udiDi>
    <basicUdiDi>93532780AIStation2U3</basicUdiDi>
    <tradeName>Kosmos Hub (Refurbished)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R006966</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000625</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos Lexsa (Refurbished)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R006709</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000632</udiDi>
    <basicUdiDi>93532780AIStation2U3</basicUdiDi>
    <tradeName>Kosmos Power Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P007640</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000694</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos OTS Android Linear Color</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P007465</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>09353278000700</udiDi>
    <basicUdiDi>93532780KOSMOSWH</basicUdiDi>
    <tradeName>Kosmos OTS Android Doppler</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EchoNous</manufacturerName>
    <manufacturerSrn>US-MF-000004161</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P007701</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:14.167Z</lastUpdated>
  </row>
</eudamedExport>