<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00841517105563</udiDi>
    <basicUdiDi>B-00841517105563</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>P23610-18R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:33.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105471</udiDi>
    <basicUdiDi>B-00841517105471</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>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51416-51A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:32.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105464</udiDi>
    <basicUdiDi>B-00841517105464</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>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51416-51</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:28.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105181</udiDi>
    <basicUdiDi>B-00841517105181</basicUdiDi>
    <tradeName>P21v/5-1 MHz</tradeName>
    <deviceName>TRANSDUCER, P21V 5-1 MHZ, IVIZ</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>P18800-51</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:27.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105174</udiDi>
    <basicUdiDi>B-00841517105174</basicUdiDi>
    <tradeName>L38v/10-5 MHz</tradeName>
    <deviceName>TRANSDUCER, L38V 10-5 MHZ, IVIZ</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>Artık piyasada değil</deviceStatus>
    <reference>P19360-51</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:26.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105167</udiDi>
    <basicUdiDi>B-00841517105167</basicUdiDi>
    <tradeName>C60V/5-2 MHZ</tradeName>
    <deviceName>TRANSDUCER, C60V 5-2 MHZ, IVIZ</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>P21244-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:26.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105150</udiDi>
    <basicUdiDi>B-00841517105150</basicUdiDi>
    <tradeName>L25V/13-6 MHZ</tradeName>
    <deviceName>TRANSDUCER, L25V 13-6 MHZ, IVIZ</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>P21877-11</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:22.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105136</udiDi>
    <basicUdiDi>B-00841517105136</basicUdiDi>
    <tradeName>L25V/13-6 MHZ</tradeName>
    <deviceName>TRANSDUCER, L25V 13-6 MHZ, IVIZ</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>Artık piyasada değil</deviceStatus>
    <reference>P21877-10A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:20.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105129</udiDi>
    <basicUdiDi>B-00841517105129</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>P06073-71A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:19.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105099</udiDi>
    <basicUdiDi>B-00841517105099</basicUdiDi>
    <tradeName>SLAx/13-6 MHz</tradeName>
    <deviceName>TRANSDUCER, SLAX/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>Artık piyasada değil</deviceStatus>
    <reference>P07699-72</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:18.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105068</udiDi>
    <basicUdiDi>B-00841517105068</basicUdiDi>
    <tradeName>C60XI/5-2 MHZ</tradeName>
    <deviceName>TRANSDUCER, C60XI/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>Piyasada</deviceStatus>
    <reference>P20402-20A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:15.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105037</udiDi>
    <basicUdiDi>B-00841517105037</basicUdiDi>
    <tradeName>C60XI/5-2 MHZ</tradeName>
    <deviceName>TRANSDUCER, C60XI/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>Piyasada</deviceStatus>
    <reference>P20402-20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:14.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104979</udiDi>
    <basicUdiDi>B-00841517104979</basicUdiDi>
    <tradeName>C60x/5-2 MHz</tradeName>
    <deviceName>TRANSDUCER, C60X/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>Piyasada</deviceStatus>
    <reference>P07680-80</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:13.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104955</udiDi>
    <basicUdiDi>B-00841517104955</basicUdiDi>
    <tradeName>SLAx/13-6 MHz</tradeName>
    <deviceName>TRANSDUCER, SLAX/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>P07699-80</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:12.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104900</udiDi>
    <basicUdiDi>B-00841517104900</basicUdiDi>
    <tradeName>P21x/5-1 MHz</tradeName>
    <deviceName>TRANSDUCER, P21X/5-1 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>Z110402010301</emdnCode>
    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P07698-80</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:08.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104801</udiDi>
    <basicUdiDi>B-00841517104801</basicUdiDi>
    <tradeName>HFL38x/13-6 MHz</tradeName>
    <deviceName>TRANSDUCER, HFL38X/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>P07682-80</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:07.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104795</udiDi>
    <basicUdiDi>B-00841517104795</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>P08010-80</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:07.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104788</udiDi>
    <basicUdiDi>B-00841517104788</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>Piyasada</deviceStatus>
    <reference>P08189-91R</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:05.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104771</udiDi>
    <basicUdiDi>B-00841517104771</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>Piyasada</deviceStatus>
    <reference>P17000-25R</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:36:15.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104764</udiDi>
    <basicUdiDi>B-00841517104764</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>Piyasada</deviceStatus>
    <reference>P17000-25C</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:36:14.729Z</lastUpdated>
  </row>
</eudamedExport>