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<eudamedExport entity="devices">
  <row>
    <udiDi>00841517100278</udiDi>
    <basicUdiDi>B-00841517100278</basicUdiDi>
    <tradeName>SonoSite S-Series</tradeName>
    <deviceName>SONOSITE S SERIES ULTRASOUND SYSTEM</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P09417-93</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:25:46.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100261</udiDi>
    <basicUdiDi>B-00841517100261</basicUdiDi>
    <tradeName>SonoSite M-Turbo</tradeName>
    <deviceName>M-TURBO ULTRASOUND SYSTEM</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P17000-15C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:25:45.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100254</udiDi>
    <basicUdiDi>B-00841517100254</basicUdiDi>
    <tradeName>SonoSite M-Turbo</tradeName>
    <deviceName>M-TURBO ULTRASOUND SYSTEM</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P17000-15R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:25:45.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100247</udiDi>
    <basicUdiDi>B-00841517100247</basicUdiDi>
    <tradeName>SonoSite Edge</tradeName>
    <deviceName>EDGE ULTRASOUND SYSTEM</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P15000-64R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:25:41.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100230</udiDi>
    <basicUdiDi>B-00841517100230</basicUdiDi>
    <tradeName>SonoSite Edge</tradeName>
    <deviceName>EDGE ULTRASOUND SYSTEM</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P15000-64</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:25:40.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100223</udiDi>
    <basicUdiDi>B-00841517100223</basicUdiDi>
    <tradeName>SonoSite Edge II</tradeName>
    <deviceName>SONOSITE EDGE II ULTRASOUND SYSTEM</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P20680-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:25:39.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100216</udiDi>
    <basicUdiDi>B-00841517100216</basicUdiDi>
    <tradeName>SonoSite SII</tradeName>
    <deviceName>SONOSITE SII ULTRASOUND SYSTEM</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P20500-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:25:38.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100032</udiDi>
    <basicUdiDi>B-00841517100032</basicUdiDi>
    <tradeName>SonoSite M-Turbo</tradeName>
    <deviceName>M-TURBO ULTRASOUND SYSTEM</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P17000-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:24:59.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852698007508</udiDi>
    <basicUdiDi>852698007508JY</basicUdiDi>
    <tradeName>Terason uSmart3200T Plus</tradeName>
    <deviceName>uSmart3200T Plus Ultrasound System without GPU, Tablet</deviceName>
    <manufacturerName>Teratech Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000033295</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-3258</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:31:03.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852698007225</udiDi>
    <basicUdiDi>852698007225JH</basicUdiDi>
    <tradeName>Terason uSmart3300 USB3</tradeName>
    <deviceName>uSmart3300 Ultrasound System USB3</deviceName>
    <manufacturerName>Teratech Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000033295</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-3303 R2</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:30:58.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852698007218</udiDi>
    <basicUdiDi>852698007218JL</basicUdiDi>
    <tradeName>Terason uSmart3200T USB3</tradeName>
    <deviceName>uSmart3200T Ultrasound System, Tablet USB3</deviceName>
    <manufacturerName>Teratech Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000033295</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-3232 R200</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:30:57.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852698007119</udiDi>
    <basicUdiDi>852698007119JH</basicUdiDi>
    <tradeName>Terason uSmart3200T</tradeName>
    <deviceName>uSmart3200T Ultrasound System, Tablet</deviceName>
    <manufacturerName>Teratech Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000033295</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-3232</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:30:53.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>00852698007102</udiDi>
    <basicUdiDi>852698007102HY</basicUdiDi>
    <tradeName>Terason uSmart3300</tradeName>
    <deviceName>uSmart3300 Ultrasound System</deviceName>
    <manufacturerName>Teratech Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000033295</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-3303</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:30:52.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056304455543</udiDi>
    <basicUdiDi>805630445ESA.US0000006.YA</basicUdiDi>
    <tradeName>AL300</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101741009</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:14:38.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056304455031</udiDi>
    <basicUdiDi>805630445ESA.US0000005.Y7</basicUdiDi>
    <tradeName>MyLabOmega eXP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101740040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:14:18.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056304454713</udiDi>
    <basicUdiDi>805630445ESA.US0000010.XV</basicUdiDi>
    <tradeName>MyLabC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100760000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:14:02.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540205001158</udiDi>
    <basicUdiDi>7540205ClariusFanBF</basicUdiDi>
    <tradeName>Clarius Fan HD</tradeName>
    <deviceName>Clarius Fan</deviceName>
    <manufacturerName>Clarius Mobile Health Corp.</manufacturerName>
    <manufacturerSrn>CA-MF-000037016</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99-03-00005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:26:04.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540205001042</udiDi>
    <basicUdiDi>7540205Clarius2in1ChargW8</basicUdiDi>
    <tradeName>Clarius 2-in-1 Charging Station</tradeName>
    <deviceName>Clarius 2-in-1 Charging Station</deviceName>
    <manufacturerName>Clarius Mobile Health Corp.</manufacturerName>
    <manufacturerSrn>CA-MF-000037016</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99-13-00016</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:26:00.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540205000915</udiDi>
    <basicUdiDi>7540205ClariusCharger6F</basicUdiDi>
    <tradeName>Clarius Charger HD</tradeName>
    <deviceName>Clarius Charger</deviceName>
    <manufacturerName>Clarius Mobile Health Corp.</manufacturerName>
    <manufacturerSrn>CA-MF-000037016</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99-13-00008</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:25:59.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540205000908</udiDi>
    <basicUdiDi>7540205ClariusBatteryBD</basicUdiDi>
    <tradeName>Clarius Battery HD</tradeName>
    <deviceName>Clarius Battery</deviceName>
    <manufacturerName>Clarius Mobile Health Corp.</manufacturerName>
    <manufacturerSrn>CA-MF-000037016</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99-13-00010</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:25:58.412Z</lastUpdated>
  </row>
</eudamedExport>