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<eudamedExport entity="devices">
  <row>
    <udiDi>00896100002248</udiDi>
    <basicUdiDi>B-00896100002248</basicUdiDi>
    <tradeName>VuMAX</tradeName>
    <deviceName>VuMAX Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>AU.575</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:00.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002231</udiDi>
    <basicUdiDi>B-00896100002231</basicUdiDi>
    <tradeName>GoVu</tradeName>
    <deviceName>GoVu Handheld Pachymeter</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GV.275</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:59.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002224</udiDi>
    <basicUdiDi>B-00896100002224</basicUdiDi>
    <tradeName>VuMAX</tradeName>
    <deviceName>VuMAX Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>BU.575</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:59.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002217</udiDi>
    <basicUdiDi>B-00896100002217</basicUdiDi>
    <tradeName>VuMAX</tradeName>
    <deviceName>VuMAX Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>BUA.575</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:58.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002200</udiDi>
    <basicUdiDi>B-00896100002200</basicUdiDi>
    <tradeName>VuMAX</tradeName>
    <deviceName>VuMAX Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>BA.575</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:54.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002194</udiDi>
    <basicUdiDi>B-00896100002194</basicUdiDi>
    <tradeName>VuMAX</tradeName>
    <deviceName>VuMAX Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>U.575</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:53.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002187</udiDi>
    <basicUdiDi>B-00896100002187</basicUdiDi>
    <tradeName>VuMAX</tradeName>
    <deviceName>VuMAX Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>B.575</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:52.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002170</udiDi>
    <basicUdiDi>B-00896100002170</basicUdiDi>
    <tradeName>VuPad</tradeName>
    <deviceName>VuPad Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>A.580</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:51.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002149</udiDi>
    <basicUdiDi>B-00896100002149</basicUdiDi>
    <tradeName>VuPad</tradeName>
    <deviceName>VuPad Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>U.580</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:47.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002163</udiDi>
    <basicUdiDi>B-00896100002163</basicUdiDi>
    <tradeName>VuPad</tradeName>
    <deviceName>VuPad Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>BUA.580</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:47.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002156</udiDi>
    <basicUdiDi>B-00896100002156</basicUdiDi>
    <tradeName>VuPad</tradeName>
    <deviceName>VuPad Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>BU.580</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:46.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002132</udiDi>
    <basicUdiDi>B-00896100002132</basicUdiDi>
    <tradeName>VuPad</tradeName>
    <deviceName>VuPad Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>BA.580</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:45.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002125</udiDi>
    <basicUdiDi>B-00896100002125</basicUdiDi>
    <tradeName>VuPad</tradeName>
    <deviceName>VuPad Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>B.580</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:29.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002118</udiDi>
    <basicUdiDi>B-00896100002118</basicUdiDi>
    <tradeName>MasterVu B</tradeName>
    <deviceName>MasterVu B-Scan</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>MV5600</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:28.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002101</udiDi>
    <basicUdiDi>B-00896100002101</basicUdiDi>
    <tradeName>MasterVu A</tradeName>
    <deviceName>MasterVu A-Scan</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>MV4500</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:26.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002095</udiDi>
    <basicUdiDi>B-00896100002095</basicUdiDi>
    <tradeName>PacScan Plus</tradeName>
    <deviceName>PacScan Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>300AP+</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:24.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002088</udiDi>
    <basicUdiDi>B-00896100002088</basicUdiDi>
    <tradeName>PacScan Plus</tradeName>
    <deviceName>PacScan Plus Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>300A+</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:22.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002064</udiDi>
    <basicUdiDi>B-00896100002064</basicUdiDi>
    <tradeName>VuPad</tradeName>
    <deviceName>VuPad Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>BUAP.580</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:22.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002057</udiDi>
    <basicUdiDi>B-00896100002057</basicUdiDi>
    <tradeName>VuPad</tradeName>
    <deviceName>VuPad Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>BUP.580</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:20.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896100002040</udiDi>
    <basicUdiDi>B-00896100002040</basicUdiDi>
    <tradeName>VuPad</tradeName>
    <deviceName>VuPad Ophthalmic Ultrasound</deviceName>
    <manufacturerName>Sonomed, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002342</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>UP.580</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:18.129Z</lastUpdated>
  </row>
</eudamedExport>