<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00857377006117</udiDi>
    <basicUdiDi>B-00857377006117</basicUdiDi>
    <tradeName>Scanmate Flex</tradeName>
    <deviceName>Scanmate Flex</deviceName>
    <manufacturerName>DGH Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008833</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040199</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLEX</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:26.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857377006100</udiDi>
    <basicUdiDi>B-00857377006100</basicUdiDi>
    <tradeName>Scanmate B</tradeName>
    <deviceName>Scanmate B</deviceName>
    <manufacturerName>DGH Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008833</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040199</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DGH 8000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:25.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857377006094</udiDi>
    <basicUdiDi>B-00857377006094</basicUdiDi>
    <tradeName>Scanmate A</tradeName>
    <deviceName>Scanmate A</deviceName>
    <manufacturerName>DGH Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008833</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040199</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DGH 6000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:24.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517111694</udiDi>
    <basicUdiDi>B-00841517111694</basicUdiDi>
    <tradeName>M-Turbo Mini-Dock</tradeName>
    <deviceName>MINIDOCK DVI, DESKTOP VERSION, M-SERIES</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>P30375-61</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:44:12.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517111687</udiDi>
    <basicUdiDi>B-00841517111687</basicUdiDi>
    <tradeName>Edge Mini-Dock</tradeName>
    <deviceName>MINIDOCK, DESKTOP VERSION, EDGE</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>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P30376-61</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:44:10.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517111670</udiDi>
    <basicUdiDi>B-00841517111670</basicUdiDi>
    <tradeName>Edge Mini-Dock</tradeName>
    <deviceName>MINIDOCK, DESKTOP VERSION, EDGE</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>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P30376-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:44:08.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517111663</udiDi>
    <basicUdiDi>B-00841517111663</basicUdiDi>
    <tradeName>M-Turbo Mini-Dock</tradeName>
    <deviceName>MINIDOCK DVI, DESKTOP VERSION, M-SERIES</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>P30375-02</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:44:06.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517111458</udiDi>
    <basicUdiDi>B-00841517111458</basicUdiDi>
    <tradeName>Battery</tradeName>
    <deviceName>BATTERY PACK ASSEMBLY, 6 CELL, LITHIUM-ION, M-TURBO</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>P30398-05</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:44:05.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517111410</udiDi>
    <basicUdiDi>B-00841517111410</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1104018099</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P30397-16</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:44:04.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517110901</udiDi>
    <basicUdiDi>B-00841517110901</basicUdiDi>
    <tradeName>Battery</tradeName>
    <deviceName>BATTERY PACK ASSEMBLY, 6 CELL, LITHIUM-ION, TURBO S</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>P07753-27</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:43:53.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517110888</udiDi>
    <basicUdiDi>B-00841517110888</basicUdiDi>
    <tradeName>Battery</tradeName>
    <deviceName>BATTERY PACK ASSEMBLY, 6 CELL, LITHIUM-ION, M-TURBO</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>P07168-27</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:43:53.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517110239</udiDi>
    <basicUdiDi>B-00841517110239</basicUdiDi>
    <tradeName>Sonosite PX</tradeName>
    <deviceName>SONOSITE MICROPHONE ACCESSORY</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>P33206-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:43:47.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517110123</udiDi>
    <basicUdiDi>B-00841517110123</basicUdiDi>
    <tradeName>Vevo MD Imaging System</tradeName>
    <deviceName>VEVO MD IMAGING SYSTEM (240V)</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>51476-55</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:43:42.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517110208</udiDi>
    <basicUdiDi>B-00841517110208</basicUdiDi>
    <tradeName>Sonosite PX</tradeName>
    <deviceName>SONOSITE PX ULTRASOUND SYSTEM, 3.1.1</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>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P31060-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:43:41.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517110116</udiDi>
    <basicUdiDi>B-00841517110116</basicUdiDi>
    <tradeName>Sonosite PX Stand Head</tradeName>
    <deviceName>SERVICE EXCHANGE, SONOSITE PX STAND HEAD, 2.0</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>P25001-25R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:43:27.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517110109</udiDi>
    <basicUdiDi>B-00841517110109</basicUdiDi>
    <tradeName>Triple Transducer Connect</tradeName>
    <deviceName>TRIPLE TRANSDUCER CONNECT, SONOSITE ZX</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>P32506-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:43:25.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517110086</udiDi>
    <basicUdiDi>B-00841517110086</basicUdiDi>
    <tradeName>Sonosite ZX Portable System</tradeName>
    <deviceName>PORTABLE SYSTEM, SONOSITE ZX</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>P32502-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:43:23.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517110024</udiDi>
    <basicUdiDi>B-00841517110024</basicUdiDi>
    <tradeName>SonoSite LX</tradeName>
    <deviceName>SONOSITE MICROPHONE ACCESSORY</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>P31093-17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:43:21.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517110017</udiDi>
    <basicUdiDi>B-00841517110017</basicUdiDi>
    <tradeName>Battery</tradeName>
    <deviceName>BATTERY, PHOENIX, MOLICEL M35A</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>P23597-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:43:20.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517109981</udiDi>
    <basicUdiDi>B-00841517109981</basicUdiDi>
    <tradeName>Sonosite PX Stand Head</tradeName>
    <deviceName>SONOSITE PX STAND HEAD, 2.0</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>P25001-26</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:43:19.353Z</lastUpdated>
  </row>
</eudamedExport>