<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00841517105945</udiDi>
    <basicUdiDi>B-00841517105945</basicUdiDi>
    <tradeName>Sonosite PX</tradeName>
    <deviceName>SONOSITE STAND BATTERY</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P27003-17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:39:07.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105938</udiDi>
    <basicUdiDi>B-00841517105938</basicUdiDi>
    <tradeName>Battery</tradeName>
    <deviceName>KIT, BATTERY, PORTABLE 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>P27852-03</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:39:07.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105921</udiDi>
    <basicUdiDi>B-00841517105921</basicUdiDi>
    <tradeName>Battery Charger</tradeName>
    <deviceName>IVIZ BATTERY CHARGER, GANGPLATE</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P19610-03</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:39:02.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105914</udiDi>
    <basicUdiDi>B-00841517105914</basicUdiDi>
    <tradeName>Sonosite PX Stand</tradeName>
    <deviceName>SONOSITE PX STAND</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P25002-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:39:01.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105907</udiDi>
    <basicUdiDi>B-00841517105907</basicUdiDi>
    <tradeName>Sonosite PX Stand Head</tradeName>
    <deviceName>SONOSITE PX STAND HEAD</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P25001-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:39:00.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105877</udiDi>
    <basicUdiDi>B-00841517105877</basicUdiDi>
    <tradeName>C5-1</tradeName>
    <deviceName>TRANSDUCER, C5-1</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>P23119-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:59.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105860</udiDi>
    <basicUdiDi>B-00841517105860</basicUdiDi>
    <tradeName>L12-3</tradeName>
    <deviceName>TRANSDUCER, L12-3</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>P22916-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:55.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105853</udiDi>
    <basicUdiDi>B-00841517105853</basicUdiDi>
    <tradeName>IC10-3</tradeName>
    <deviceName>TRANSDUCER, IC10-3</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>P23121-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:55.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105846</udiDi>
    <basicUdiDi>B-00841517105846</basicUdiDi>
    <tradeName>L19-5</tradeName>
    <deviceName>TRANSDUCER, L19-5</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>P23972-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:54.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105792</udiDi>
    <basicUdiDi>B-00841517105792</basicUdiDi>
    <tradeName>SII Stand</tradeName>
    <deviceName>SONOSITE SII STAND</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P21432-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:53.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105785</udiDi>
    <basicUdiDi>B-00841517105785</basicUdiDi>
    <tradeName>Edge Stand</tradeName>
    <deviceName>EDGE STAND</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P15800-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:48.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105778</udiDi>
    <basicUdiDi>B-00841517105778</basicUdiDi>
    <tradeName>V-Universal Stand</tradeName>
    <deviceName>V-UNIVERSAL STAND</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P12738-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:47.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105761</udiDi>
    <basicUdiDi>B-00841517105761</basicUdiDi>
    <tradeName>H-Universal Stand</tradeName>
    <deviceName>H-UNIVERSAL STAND</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P12163-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:47.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105747</udiDi>
    <basicUdiDi>B-00841517105747</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>P28965-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:46.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105709</udiDi>
    <basicUdiDi>B-00841517105709</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>P28965-25C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:42.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105693</udiDi>
    <basicUdiDi>B-00841517105693</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>P28965-25R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:41.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105662</udiDi>
    <basicUdiDi>B-00841517105662</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>P19360-15A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:40.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105617</udiDi>
    <basicUdiDi>B-00841517105617</basicUdiDi>
    <tradeName>P5-1</tradeName>
    <deviceName>TRANSDUCER, P5-1</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>P24087-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:39.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105594</udiDi>
    <basicUdiDi>B-00841517105594</basicUdiDi>
    <tradeName>Power Pack</tradeName>
    <deviceName>KIT, POWER PACK WITH UDI</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P13559-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:34.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517105570</udiDi>
    <basicUdiDi>B-00841517105570</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>P07682-80A</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:38:34.197Z</lastUpdated>
  </row>
</eudamedExport>