<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00841517102692</udiDi>
    <basicUdiDi>B-00841517102692</basicUdiDi>
    <tradeName>SonoSite X-Porte</tradeName>
    <deviceName>X-PORTE ENGINE, CW</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>P16055-35</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:32:10.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102685</udiDi>
    <basicUdiDi>B-00841517102685</basicUdiDi>
    <tradeName>SonoSite X-Porte</tradeName>
    <deviceName>X-PORTE ENGINE, CW</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>P16055-32</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:32:07.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102630</udiDi>
    <basicUdiDi>B-00841517102630</basicUdiDi>
    <tradeName>HFL50xp/15-6 MHz</tradeName>
    <deviceName>TRANSDUCER, HFL50XP/15-6 MHZ</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>Z1104020201</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P14567-21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:32:06.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102586</udiDi>
    <basicUdiDi>B-00841517102586</basicUdiDi>
    <tradeName>C8x/8-5 MHz</tradeName>
    <deviceName>TRANSDUCER, C8X/8-5 MHZ CURVED ARRAY, COAX CABLE</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>Z110402010201</emdnCode>
    <emdnDescription>CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES  (CONVEX–ARRAY)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P08010-71</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:32:05.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102579</udiDi>
    <basicUdiDi>B-00841517102579</basicUdiDi>
    <tradeName>C60E/5-2 MHZ</tradeName>
    <deviceName>TRANSDUCER, C60E/5-2 MHZ</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>Z110402010201</emdnCode>
    <emdnDescription>CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES  (CONVEX–ARRAY)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P07633-71</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:32:03.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102562</udiDi>
    <basicUdiDi>B-00841517102562</basicUdiDi>
    <tradeName>P17/5-1 MHZ</tradeName>
    <deviceName>TRANSDUCER, P17/5-1 MHZ, BIOPSY COMPATIBLE</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>Z110402010301</emdnCode>
    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P06073-71</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:32:01.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102555</udiDi>
    <basicUdiDi>B-00841517102555</basicUdiDi>
    <tradeName>L38E/10-5 MHZ</tradeName>
    <deviceName>TRANSDUCER, L38E/10-5 MHZ</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>Z1104020201</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P05482-71</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:31:59.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102548</udiDi>
    <basicUdiDi>B-00841517102548</basicUdiDi>
    <tradeName>Vevo MD Imaging System</tradeName>
    <deviceName>VEVO MD IMAGING SYSTEM (120V)</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>51475-44</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:31:59.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102524</udiDi>
    <basicUdiDi>B-00841517102524</basicUdiDi>
    <tradeName>Vevo MD Imaging System</tradeName>
    <deviceName>VEVO MD IMAGING SYSTEM (120V)</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>51475-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:31:57.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102463</udiDi>
    <basicUdiDi>B-00841517102463</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>P23620-13</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:31:55.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102425</udiDi>
    <basicUdiDi>B-00841517102425</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>P20883-13R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:31:53.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102418</udiDi>
    <basicUdiDi>B-00841517102418</basicUdiDi>
    <tradeName>SonoSite Edge II</tradeName>
    <deviceName>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>P20680-12R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:31:52.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102401</udiDi>
    <basicUdiDi>B-00841517102401</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>P20500-13R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:31:51.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102371</udiDi>
    <basicUdiDi>B-00841517102371</basicUdiDi>
    <tradeName>HSL25xp/13-6 MHz</tradeName>
    <deviceName>TRANSDUCER, HSL25XP/13-6 MHZ</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>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P18657-21A</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:31:48.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102364</udiDi>
    <basicUdiDi>B-00841517102364</basicUdiDi>
    <tradeName>HSL25xp/13-6 MHz</tradeName>
    <deviceName>TRANSDUCER, HSL25XP/13-6 MHZ</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>Z1104020201</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P18657-21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:31:47.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102357</udiDi>
    <basicUdiDi>B-00841517102357</basicUdiDi>
    <tradeName>UHF70 Transducer</tradeName>
    <deviceName>UHF70: 70 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER</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>Z1104020201</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>51416-30A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:31:46.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102333</udiDi>
    <basicUdiDi>B-00841517102333</basicUdiDi>
    <tradeName>UHF48 Transducer</tradeName>
    <deviceName>UHF48: 48 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER</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>Z1104020201</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>51415-30A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:31:44.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102340</udiDi>
    <basicUdiDi>B-00841517102340</basicUdiDi>
    <tradeName>UHF70 Transducer</tradeName>
    <deviceName>UHF70: 70 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER</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>Z1104020201</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>51416-30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:31:42.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102319</udiDi>
    <basicUdiDi>B-00841517102319</basicUdiDi>
    <tradeName>UHF22 Transducer</tradeName>
    <deviceName>UHF22: 22 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER</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>Z1104020201</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>51414-30A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:31:40.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517102326</udiDi>
    <basicUdiDi>B-00841517102326</basicUdiDi>
    <tradeName>UHF48 Transducer</tradeName>
    <deviceName>UHF48: 48 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER</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>Z1104020201</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>51415-30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:31:39.968Z</lastUpdated>
  </row>
</eudamedExport>