<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00841517104757</udiDi>
    <basicUdiDi>B-00841517104757</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>P08189-91</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:36:13.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104740</udiDi>
    <basicUdiDi>B-00841517104740</basicUdiDi>
    <tradeName>SonoSite X-Porte</tradeName>
    <deviceName>X-PORTE 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>P19220-22</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:36:11.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104733</udiDi>
    <basicUdiDi>B-00841517104733</basicUdiDi>
    <tradeName>SonoSite X-Porte</tradeName>
    <deviceName>X-PORTE 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>P19220-77</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:36:09.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104726</udiDi>
    <basicUdiDi>B-00841517104726</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>51475-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:36:09.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104719</udiDi>
    <basicUdiDi>B-00841517104719</basicUdiDi>
    <tradeName>SonoSite iViz</tradeName>
    <deviceName>IVIZ MEDICAL DIAGNOSTIC TABLET</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>P20830-26</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:36:07.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104702</udiDi>
    <basicUdiDi>B-00841517104702</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>Piyasada</deviceStatus>
    <reference>P24550-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:36:05.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104696</udiDi>
    <basicUdiDi>B-00841517104696</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>Artık piyasada değil</deviceStatus>
    <reference>51416-50A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:36:03.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104689</udiDi>
    <basicUdiDi>B-00841517104689</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>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51415-50A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:36:02.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104672</udiDi>
    <basicUdiDi>B-00841517104672</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>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51414-50A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:36:01.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104665</udiDi>
    <basicUdiDi>B-00841517104665</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>P17000-25</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:35:58.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104641</udiDi>
    <basicUdiDi>B-00841517104641</basicUdiDi>
    <tradeName>Power Park</tradeName>
    <deviceName>ASSEMBLY, POWERPARK STAND MODULE</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>P12822-45</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:35:57.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104627</udiDi>
    <basicUdiDi>B-00841517104627</basicUdiDi>
    <tradeName>L25n/13-6 MHz</tradeName>
    <deviceName>TRANSDUCER, L25N-128/13-6 MHZ, NANOMAXX</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>P12092-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:35:56.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104610</udiDi>
    <basicUdiDi>B-00841517104610</basicUdiDi>
    <tradeName>C11n/8-5 MHz</tradeName>
    <deviceName>TRANSDUCER, C11N/8-5 MHZ, NANOMAXX</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>P11880-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:35:54.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104603</udiDi>
    <basicUdiDi>B-00841517104603</basicUdiDi>
    <tradeName>P21n/5-1 MHz</tradeName>
    <deviceName>TRANSDUCER, P21N/5-1 MHZ, NANOMAXX</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>P11879-22</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:35:52.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104597</udiDi>
    <basicUdiDi>B-00841517104597</basicUdiDi>
    <tradeName>C60n/5-2 MHz</tradeName>
    <deviceName>TRANSDUCER, C60N/5-2 MHZ, NANOMAXX</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>P11878-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:35:50.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104580</udiDi>
    <basicUdiDi>B-00841517104580</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>P24550-02R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:35:49.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104566</udiDi>
    <basicUdiDi>B-00841517104566</basicUdiDi>
    <tradeName>SonoSite iViz</tradeName>
    <deviceName>IVIZ MEDICAL DIAGNOSTIC TABLET</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>P27300-01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:35:48.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104573</udiDi>
    <basicUdiDi>B-00841517104573</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>P20883-17R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:35:45.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104542</udiDi>
    <basicUdiDi>B-00841517104542</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>P17000-18C</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:35:44.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517104559</udiDi>
    <basicUdiDi>B-00841517104559</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>P17000-18R</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:35:43.496Z</lastUpdated>
  </row>
</eudamedExport>